The ASCEND Study: Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma (ASCEND)

October 20, 2024 updated by: Australasian Gastro-Intestinal Trials Group

A Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

The purpose of the ASCEND clinical trial is to measure the effect of adding LSTA1 (certepetide), compared to placebo, to chemotherapy (gemcitabine and nab-paclitaxel) in patients who have untreated metastatic pancreatic cancer. The study will assess the duration which the cancer remained stable or improved, the number of patients who responded to treatment, overall survival, side effects and quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

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.
158

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

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Border Medical Oncology
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Clayton, New South Wales, Australia, 3168
        • Monash Medical Centre
      • Gateshead, New South Wales, Australia, 2290
        • Lake Macquarie Private Hospital
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital
      • Newcastle, New South Wales, Australia
        • Newcastle Private Hospital
      • Newcastle, New South Wales, Australia
        • Calvary Mater Newcastle
      • Sydney, New South Wales, Australia
        • Prince of Wales Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Icon Cancer Centre Wesley
      • Birtinya, Queensland, Australia, 575
        • Sunshine Coast University Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Womens Hospital
      • Southport, Queensland, Australia, 4215
        • ICON Cancer Centre, Gold Coast University Hospital
    • South Australia
      • Adelaide, South Australia, Australia
        • Flinders Medical Centre
      • Woodville South, South Australia, Australia, 5011
        • Queen Elizabeth Hospital
    • Tasmania
      • Launceston, Tasmania, Australia
        • Launceston General Hospital
    • Victoria
      • Epping, Victoria, Australia, 3076
        • Northern Health
      • Heidelberg, Victoria, Australia, 3084
        • Warringal Private Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Melbourne, Victoria, Australia
        • Frankston Hospital
      • Richmond, Victoria, Australia, 3121
        • Epworth Healthcare
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
      • Subiaco, Western Australia, Australia, 6008
        • St John of God
  • New Zealand
      • Dunedin, New Zealand
        • Dunedin Hospital
      • Hamilton, New Zealand
        • Waikato Hospital

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:

  • Adults, 18 years or older with histologically confirmed metastatic pancreatic ductal adenocarcinoma or poorly differentiated carcinoma.
  • Measurable disease according to RECIST 1.1.
  • Archival tumour tissue for tertiary correlative studies (biopsy or resection of primary or metastasis). Fine needle aspirate (FNA) or brushings will not be accepted.
  • ECOG performance of 0-1 (Appendix 2)
  • Adequate renal and haematological function
  • Adequate hepatic function, defined as:

Bilirubin <1.5 X ULN (Upper Limit of Normal), AST or ALT ≤ 5x ULN. If a person was recently stented with improving bilirubin, the person can be randomised with bilirubin up to 3 x ULN provided chemotherapy is not administered until within the stated thresholds.

  • Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
  • Study treatment both planned and able to start within 7 days after randomisation
  • Signed, written informed consent.

Exclusion Criteria:

  • Uncontrolled metastatic disease to the central nervous system. To be eligible, known CNS metastases should have been treated with surgery and/or radiotherapy and the patient should have been receiving a stable dose of steroids for at least 2 weeks prior to randomisation, with no deterioration in neurological symptoms during this time.
  • Prior chemotherapy or investigational anti-cancer therapy for metastatic pancreatic adenocarcinoma. Prior treatments with curative intent or for locally advanced disease are allowed, provided the last dose of chemotherapy was administered more than 6 months prior to randomisation.
  • Prior radiotherapy or major surgery (as defined by local investigator) within 14 days of starting treatment.
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anti-cancer therapy with the exception of alopecia, vitiligo and the laboratory values defined in the inclusion criteria. Participants with Grade ≥2 peripheral neuropathy are not allowed.
  • Concurrent use of any other anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy or biological agents.
  • Known allergy or hypersensitivity to any of the study drugs and excipients.
  • Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV. Participants with known Hepatitis B/C infection will be allowed to participate providing evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy.

  • History of prior or synchronous malignancy within 2 years prior to randomisation, except:

    1. Malignancy that was treated with curative intent and for which there has been no known active disease for ≥2 years prior to randomisation.
    2. Curatively treated non-melanoma skin cancer, cervical cancer in situ, superficial transitional cell carcinoma of the bladder, stage 1 endometrial carcinoma, prostatic intraepithelial neoplasia, low-grade papillary thyroid cancer, untreated localised very low risk or low risk prostate cancer under observation.
  • Concurrent illness, including severe infection that may jeopardise the ability of the person to undergo the procedures outlined in this protocol with reasonable safety.
  • Neuroendocrine pancreatic carcinoma.
  • Life expectancy of less than 3 months.
  • Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to randomisation. Men must use a reliable means of contraception.
  • Serious medical or psychiatric conditions that might limit the ability of the person to comply with the protocol.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
Placebo Comparator: Cohort A: Standard Care + Placebo
Participants will receive nab-paclitaxel 125mg/m2; placebo IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
Drug: Gemcitabine Injection
Chemotherapy drug provided as solution to be administered via IV infusion.
Other Names:
  • Gemzar
Drug: Nab paclitaxel
Chemotherapy drug provided as solution to be administered via IV infusion.
Other Names:
  • Abraxane
Placebo Comparator: Cohort B: Standard Care + Placebo
Participants will receive nab-paclitaxel 125mg/m2; placebo IV; Gemcitabine 1000mg/m2, and then +~4hrs matching placebo IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
Drug: Gemcitabine Injection
Chemotherapy drug provided as solution to be administered via IV infusion.
Other Names:
  • Gemzar
Drug: Nab paclitaxel
Chemotherapy drug provided as solution to be administered via IV infusion.
Other Names:
  • Abraxane
Experimental: Cohort A: Standard Care + LSTA1 (1 dose)
Participants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
Drug: Gemcitabine Injection
Chemotherapy drug provided as solution to be administered via IV infusion.
Other Names:
  • Gemzar
Drug: Nab paclitaxel
Chemotherapy drug provided as solution to be administered via IV infusion.
Other Names:
  • Abraxane
Drug: LSTA1
LSTA1 is a novel cyclic tumour-penetrating peptide iRGD (internalizing Arginylglycylaspartic acid) which may overcome poor drug delivery by activation of a complex trans-tissue transport pathway, providing an opportunity to overcome this mechanism of resistance in PDAC
Other Names:
  • CEND-1, certepetide
Experimental: Cohort B: Standard Care +LSTA1 (2 doses)
Participants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; Gemcitabine 1000mg/m2, and then +~4hrs LSTA1 3.2mg/kg IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
Drug: Gemcitabine Injection
Chemotherapy drug provided as solution to be administered via IV infusion.
Other Names:
  • Gemzar
Drug: Nab paclitaxel
Chemotherapy drug provided as solution to be administered via IV infusion.
Other Names:
  • Abraxane
Drug: LSTA1
LSTA1 is a novel cyclic tumour-penetrating peptide iRGD (internalizing Arginylglycylaspartic acid) which may overcome poor drug delivery by activation of a complex trans-tissue transport pathway, providing an opportunity to overcome this mechanism of resistance in PDAC
Other Names:
  • CEND-1, certepetide

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
Progression Free Survival
Time Frame: From date of randomization to 18 months later, or death
Period of time from randomization to the date of first evidence of disease progression, the occurrence of new disease or death from any cause
From date of randomization to 18 months later, or death

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
Overall Survival
Time Frame: From date of randomization to 18 months later, or death
Period of time from randomization to date of death from any cause, or the date of last known follow-up alive
From date of randomization to 18 months later, or death
Objective Tumour Response Rate
Time Frame: From date of randomization to 18 months later, or death
The number of participants with documented partial or complete response (PR or CR) divided by the number of participants evaluable for response as defined as per the RECIST version 1.1 criteria
From date of randomization to 18 months later, or death
Patient-reported Outcomes
Time Frame: Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Completion of the EORTC QLQ-C30 questionnaire. 30 questions; 28 on a 1-4 scale (Higher scores indicative of poorer quality of life), 2 on a 1-7 scale (higher scores indicative of better health/quality of life).
Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Patient-reported Outcomes
Time Frame: Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Completion of the QLQ-PAN26 questionnaire. 26 questions on a 1-4 scale (Higher scores indicative of poorer quality of life)
Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Incidence of Treatment-Emergent Adverse Events (Patient Safety)
Time Frame: From date of randomization until 30 days after final treatment visit
Record of all adverse events (including SAEs) that patients experience
From date of randomization until 30 days after final treatment visit

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.
Australasian Gastro-Intestinal Trials Group

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.
University of Sydney

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.
  • Study Chair: Andrew Dean, St John of God Hospital
  • Study Chair: Timothy Price, The Queen Elizabeth Hospital

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

  • Dean A, Gill S, McGregor M, et al. 1528P Phase I trial of the first-in-class agent CEND-1 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer. Annals of Oncology 2020; 31: S941.

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.
April 13, 2022

Primary Completion (Estimated)

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.
June 1, 2025

Study Completion (Estimated)

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.
October 1, 2025

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).
August 25, 2021

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.
September 8, 2021

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.
September 13, 2021

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.
October 22, 2024

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.
October 20, 2024

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.
April 1, 2024

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.
  • CTC0304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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