Trial of Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) (AA NABPLAGEM)

June 25, 2026 updated by: HonorHealth Research Institute

Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have No Prior Therapy for Their Metastatic Pancreatic Cancer

The purpose of this study is to see if a treatment regimen with a combination of paclitaxel protein bound (also known as nab-paclitaxel), gemcitabine, and cisplatin when given with high dose Ascorbic Acid will be safe and effective in individuals with untreated metastatic pancreatic cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pancreatic cancer continues to be a very lethal disease. It was estimated that in 2016, 53,070 Americans would be diagnosed with pancreatic ductal adenocarcinoma (PDA), and 41,780 would die from the disease. This makes pancreatic cancer the third leading cause of death from cancer in the US.

PDA is the twelfth most common cancer in the world with 338,000 new cases diagnosed in 2012. It is estimated that worldwide there will be > 300,000 deaths from pancreatic cancer. Furthermore unfortunately PDA is projected to be the second leading cause of death from cancer in the US by 2030.

Detection of pancreatic cancer has notoriously been very late in the disease and therefore the 5-year survival rate is only 8%, which is actually a slight improvement over the last few years. Right now the only potential cure for pancreatic cancer is surgical resection (if the disease is caught early). However only about 20% of PDA patients are eligible for potentially curable resection and unfortunately most (> 80%) have recurrence of their cancer within 2 years of resection, and those recurrences are almost universally fatal.

Recently it has been shown that there are regimens that actually improve survival for patients with advanced stage IV PDA. Conroy and colleagues have developed the Folfirinox regimen, which in a large randomized trial improved survival over gemcitabine as a single agent. Von Hoff and colleagues developed the nanoparticle albumin (nab) associated paclitaxel plus gemcitabine regimen which improved survival over single agent gemcitabine. Even more recently Jameson and colleagues have presented a combined regimen of nab-paclitaxel + gemcitabine + cisplatin in a small 24 patient phase Ib/II trial which showed a response rate of 71% with 2 patients having complete response, a 1-year survival of 65% and a median survival of 16+ months.

While there have been multiple investigators and investigations into the use of ascorbic acid for patients with cancer (see ClinTrials.gov), its use has generally not been found to be of help for patients particularly when given orally - e.g. 10 grams daily.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients must meet the following criteria to be included in the trial:

  • Be willing and able to provide written informed consent/assent for the trial.
  • Be ≥ 18 years of age on day of signing informed consent.
  • Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (with measurable disease according to RECIST 1.1 criteria).
  • Have a performance status of 0 or 1 on the ECOG performance scale.
  • Demonstrate adequate organ function as defined below in table 4. All screening labs should be performed within 14 days of treatment initiation.
  • Female participants of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving first dose of study medication.
  • Female participants of childbearing potential must be willing to use adequate method of contraception (as outlined in section 4.4.2) for the duration of the trial.
  • Male participants must agree to use adequate contraception (as outlined in section 4.4.2) for the duration of the trial.

Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.

Exclusion Criteria:

Patients must not meet any of the following criteria in order to be eligible for the trial:

  • Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
  • Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
  • Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
  • Patients who need constant use of finger stick blood glucose monitoring for tight contro l of their diabetes being the ascorbic acid causes false low readings of glucose via that technology (Vasudevan and Hirsch 2014) 39
  • Any person with a G6PD deficiency
  • History of renal oxalate stones (if type of stone is unknown, need to assess urine oxalates level if >60mg/dL, then patient is not eligible for the study)
  • Patient is taking acetaminophen at any dose, or any medication that contains acetaminophen within 72 hours of first dose of ascorbic acid.
  • Hypersensitivity to any of the agents proposed for treatment.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through one week from the last dose of trial treatment.
  • Patients with evidence of iron overload, defined as a transferrin saturation > 45 percent AND serum ferritin > 200 ng/mL (males) or >150 ng/mL (females).
  • Current, serious, clinically significant cardiac arrhythmias as determined by the investigator, or patient receiving a digitalis derivative.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High Dose Ascorbic Acid 25 g/m^2
25 grams/m^2 of ascorbic acid via infusion at the rate of 0.5 - 1.0 grams/minute (max). Infusions will occur two times per week administered prior to chemotherapy during weeks 1 & 2 and on intervening weeks of a 21-day cycle. Approximate days for ascorbic acid infusion will be Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle.
Drug: High Dose Ascorbic Acid 25 g/m^2
2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle
Other Names:
  • AA
Drug: Nanoparticle Paclitaxel protein bound 125mg/m^2
30 minute IV infusions on days 1 and 8 repeated every 21 days
Other Names:
  • Abraxane
Drug: Cisplatin 25mg/m^2
Via 500mL of Normal Saline over 60 minute IV infusion on days 1 and 8 repeated every 21 days
Other Names:
  • Platinol
Drug: Gemcitabine 1000mg/m^2
Via 500mL of Normal Saline over 30 minute IV infusion on days 1 and 8 repeated every 21 days
Other Names:
  • Gemzar
Experimental: High Dose Ascorbic Acid 37.5 g/m^2
37.5 g/m^2 of ascorbic acid via infusion at the rate of 0.5 - 1.0 grams/minute (max). Infusions will occur two times per week administered prior to chemotherapy during weeks 1 & 2 and on intervening weeks of a 21-day cycle. Approximate days for ascorbic acid infusion will be Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle.
Drug: Nanoparticle Paclitaxel protein bound 125mg/m^2
30 minute IV infusions on days 1 and 8 repeated every 21 days
Other Names:
  • Abraxane
Drug: Cisplatin 25mg/m^2
Via 500mL of Normal Saline over 60 minute IV infusion on days 1 and 8 repeated every 21 days
Other Names:
  • Platinol
Drug: Gemcitabine 1000mg/m^2
Via 500mL of Normal Saline over 30 minute IV infusion on days 1 and 8 repeated every 21 days
Other Names:
  • Gemzar
Drug: High Dose Ascorbic Acid 37.5 g/m^2
2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle
Other Names:
  • AA
Experimental: High Dose Ascorbic Acid 56.25 g/m^2
56.25 g/m^2 of ascorbic acid via infusion at the rate of 0.5 - 1.0 grams/minute (max). Infusions will occur two times per week administered prior to chemotherapy during weeks 1 & 2 and on intervening weeks of a 21-day cycle. Approximate days for ascorbic acid infusion will be Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle.
Drug: Nanoparticle Paclitaxel protein bound 125mg/m^2
30 minute IV infusions on days 1 and 8 repeated every 21 days
Other Names:
  • Abraxane
Drug: Cisplatin 25mg/m^2
Via 500mL of Normal Saline over 60 minute IV infusion on days 1 and 8 repeated every 21 days
Other Names:
  • Platinol
Drug: Gemcitabine 1000mg/m^2
Via 500mL of Normal Saline over 30 minute IV infusion on days 1 and 8 repeated every 21 days
Other Names:
  • Gemzar
Drug: High Dose Ascorbic Acid 56.25 g/m^2
2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle
Other Names:
  • AA
Experimental: High Dose Ascorbic Acid 75 g/m^2
75 g/m^2 of ascorbic acid via infusion at the rate of 0.5 - 1.0 grams/minute (max). Infusions will occur two times per week administered prior to chemotherapy during weeks 1 & 2 and on intervening weeks of a 21-day cycle. Approximate days for ascorbic acid infusion will be Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle.
Drug: Nanoparticle Paclitaxel protein bound 125mg/m^2
30 minute IV infusions on days 1 and 8 repeated every 21 days
Other Names:
  • Abraxane
Drug: Cisplatin 25mg/m^2
Via 500mL of Normal Saline over 60 minute IV infusion on days 1 and 8 repeated every 21 days
Other Names:
  • Platinol
Drug: Gemcitabine 1000mg/m^2
Via 500mL of Normal Saline over 30 minute IV infusion on days 1 and 8 repeated every 21 days
Other Names:
  • Gemzar
Drug: High Dose Ascorbic Acid 75 g/m^2
2x per week IV infusion Normal Saline on days Day 1, 3, 8, 10, 15, and 17 of each 21-day cycle
Other Names:
  • AA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Dose Received [Identifying Recommended Maximum Tolerated Dose (MTD)]
Time Frame: From enrollment through end of treatment, up to 40 weeks
To determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the total dose received of ascorbic acid (g/m^2) by participants was measured.
From enrollment through end of treatment, up to 40 weeks
Duration of Dose in Days [Identifying Recommended Maximum Tolerated Dose (MTD)]
Time Frame: From enrollment through end of treatment, up to 40 weeks
To determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the duration of ascorbic acid dose in days is reported.
From enrollment through end of treatment, up to 40 weeks
Duration of Dose in Weeks [Identifying Recommended Maximum Tolerated Dose (MTD)]
Time Frame: From enrollment through end of treatment, up to 40 weeks
To determine the maximum tolerated dose (MTD) of high dose ascorbic acid (AA) with triple therapy of nanoparticle paclitaxel protein bound+ cisplatin + gemcitabine (NABPLAGEM) in patients with advanced stage IV metastatic pancreatic cancer, the duration of ascorbic acid dose in weeks is reported.
From enrollment through end of treatment, up to 40 weeks
Disease Control Rate (CR+PR+SD at 18 Weeks)
Time Frame: 18 weeks
Preliminary efficacy as measured by disease control rate (DCR), defined as the percentage of patients with complete response (CR) + partial response (PR) + stable disease (SD) at 18 weeks according to RECIST v1.1. CR = disappearance of all target lesions; PR = at least 30% decrease in sum of the longest diameters for target lesions, SD = insufficient change to qualify for PR or progressive disease [defined as at least 20% increase in sum of the longest diameters for target lesions].
18 weeks
Best Overall Response
Time Frame: From enrollment through end of treatment, up to 36 weeks
Best overall response according to RECIST v1.1. Complete response (CR) = disappearance of all target lesions; Partial response (PD) = at least 30% decrease in sum of the longest diameters for target lesions; Stable disease (SD) = insufficient change to qualify for PR or PD; Progressive disease (PD) = at least 20% increase in sum of the longest diameters for target lesions.
From enrollment through end of treatment, up to 36 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Toxicities
Time Frame: From enrollment through 30 days after the end of treatment, up to 40 weeks
Incidence of adverse events reported according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
From enrollment through 30 days after the end of treatment, up to 40 weeks
Normalization of Tumor Markers by AA Treatment Group
Time Frame: From enrollment through study completion, up to 40 weeks
The percentage of patients who had elevated levels of tumor marker CA 19-9 (or CA-125/CEA if not expressors of CA 19-9) and had their levels normalize. Elevated levels were defined as any value >35 U/mL for CA 19-9, >35 U/mL for CA-125, and >3 ng/mL for CEA. Normalization was defined as any patient who had elevated tumor marker values at baseline and decreased to CA 19-9 value of 0.0-35 U/mL, CA-125 value of 0.0-35 U/mL, or CEA value of 0.0-3 ng/mL during treatment.
From enrollment through study completion, up to 40 weeks
Overall Survival
Time Frame: Approximately 12 weeks from last study treatment, assessed up to 3 years
Telephone follow-up conducted every 12 weeks from the last dose of treatment to determine survival status.
Approximately 12 weeks from last study treatment, assessed up to 3 years
Progression-free Survival
Time Frame: Approximately 12 weeks from last study treatment, assessed up to 3 years
Telephone follow-up conducted every 12 weeks from the last dose of treatment to determine status of disease progression.
Approximately 12 weeks from last study treatment, assessed up to 3 years
Quality of Life: MD Anderson's Symptom Inventory-GI (MDASI-GI)
Time Frame: From Cycle 1 to end of treatment, up to 40 weeks
Changes in patient's self-reported quality of life as determined by administering the MD Anderson Symptom Inventory (MDASI-GI). This questionnaire asks patients to rank the severity of symptoms using a 0-10 scale (0 = not present to 10 = as bad as you can imagine) and averages the responses of 18 questions to produce an MDASI-GI score on a 0-10 scale. MDASI-GI scores measured at the start of Cycle 1 and at the end of treatment (EOT) are reported here.
From Cycle 1 to end of treatment, up to 40 weeks
Quality of Life: Brief Pain Inventory (BPI) - Pain Intensity (PI)
Time Frame: From start of Cycle 1 to end of treatment, up to 40 weeks
Changes in patient's self-reported pain levels determined by administering the Brief Pain Inventory (BPI) - Pain Intensity (PI) assessment. This questionnaire asks about pain intensity using a 0-10 scale (0 = not present to 10 = as bad as you can imagine) and averages the responses of 4 questions to output a BPI-PI score on a 0-10 scale. BPI-PI scores measured at the start of Cycle 1 and at the end of treatment (EOT) are reported here.
From start of Cycle 1 to end of treatment, up to 40 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tumor Texture on Radiologic Scans
Time Frame: approximately 63 days
Imaging completed to evaluate tumor texture on radiologic scans as a non-invasive imaging biomarker for response, biologic, pathologic and outcome measures.
approximately 63 days
Correlation Between Peak Plasma Concentration of Ascorbic Acid and Response to Treatment
Time Frame: approximately 63 days
Lab testing will be completed to evaluate the correlation between peak plasma concentration of ascorbic acid and response to treatment
approximately 63 days
Potential Tumor Biomarkers
Time Frame: approximately 63 days
Tumor biopsy testing will be completed to evaluate potential biomarkers in the tumor including tumor immune cell infiltration, stromal activation, stem cell enumeration, metabolic profiles, whole exome and whole genome CN, ChIP-seq/ATAQ seq, IHC and PCR assays on immune cell populations, CAFs, stem cell content (CD133, Aldh) and Musashi
approximately 63 days
Potential Blood Biomarkers
Time Frame: approximately 63 days
Lab testing will be completed to evaluate potential biomarkers in the blood samples. Test may include CTCs/circCSC enumeration, Single CTC/circCSC transcription profiling, immune profiling [CD4+CD8+ T cells, MDSC (IDO-1+HLR-DR-/lowCD33+CD11b+CD14+), Immunosuppressive plasmocytes (CD19+CD138+IgA+IL-10+PD-L1+), Th17 (CD3+gdTCR+IL-17A+), Treg (CD4+Foxp3+), Hypo-responsive NK cells (CD3-CD56+KIR-NKG2A-), cfDNA, GPC1+ exosomes.
approximately 63 days
Changes in Circulating Tumor Stem Cells
Time Frame: approximately 63 days
Lab testing will be completed to evaluate changes in numbers of circulating tumor stem cells and macrophage lineage changes
approximately 63 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HonorHealth Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cancer Research UK
University of Arizona
Stand Up To Cancer
Lustgarten Foundation
Salk Institute for Biological Studies
Translational Genomics Research Institute
Princeton University
Cold Spring Harbor Laboratory
Barts Cancer Institute
Imaging Endpoints

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gayle S Jameson, RN, MSN, ACNP-BC, AOCN, HonorHealth Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SU2C HRI NPG-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If the study site is a 'covered site' under the definitions of the Health Insurance Portability and Accounting Act (HIPAA), the Investigator will ensure that the patient consents to the use of data by HonorHealth and its designees for the purposes of regulatory submissions, study publications, and drug approval.

SU2C will be notified of any outputs of the research such as guidelines, publications, presentation, changes in service delivery etc. prior to external submission or presentation. In any oral or written report or poster presentation of Results or otherwise relating to the Research, the support of CRUK, SU2C and the Lustgarten foundation will be acknowledged, displaying the relevant logs where possible. Any publications resulting from research funded in whole or in part by the Grant must be cited as required per signed confidentiality agreements.

IPD Sharing Time Frame

to be determined

IPD Sharing Access Criteria

The Investigator and any other study personnel involved in this study shall not disclose, or use for any purposes (other than for the performance of this study), any data, records, or other information (hereinafter collectively "information") disclosed to the Investigator or other study personnel. Such information shall remain the confidential and proprietary property of HonorHealth, and shall be disclosed only to the Investigator or other designated study personnel.

The obligation of non-disclosure shall not apply to the following:

  • relevant disclosure to potential study participants for the purpose of obtaining informed consent;
  • information after such time that it is or becomes publicly available through no fault of the Investigator or other study personnel; and,
  • information after such time that it is disclosed to the Investigator by a third party entitled to disclose such information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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