A Study of CPI-613 With Gemcitabine and Nab-paclitaxel for Patients With Advanced or Metastatic Pancreatic Cancer

February 9, 2018 updated by: Atlantic Health System

A Phase I Study of CPI-613 in Combination With Gemcitabine and Nab-paclitaxel (Abraxane) for Patients With Locally Advanced or Metastatic Pancreatic Cancer

This is a single arm, open-label study of CPI-613 in combination with gemcitabine and nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer never treated with systemic chemotherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The primary specific aim of the study is to establish the maximum tolerated dose (MTD) of CPI-613 when given in combination with gemcitabine/nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • 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
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Sub-Investigator:
          • Joshua Strauss, MD
        • Principal Investigator:
          • Angela T Alistar, MD
      • Summit, New Jersey, United States, 07901
        • Recruiting
        • Overlook Medical Center
        • Contact:
        • Sub-Investigator:
          • Sophie D Morse, MD

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically or cytologically documented and measurable stage III or IV pancreatic adenocarcinoma.
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  3. First line treatment for patients diagnosed with metastatic disease
  4. First line treatment for patients with locally advanced pancreatic cancer who have not been treated with systemic therapies. Prior treatment with chemoradiation is allowed if 4 or more weeks have passed from completion of chemo-radiotherapy.
  5. Expected survival > 3 months.
  6. Women of child-bearing potential must use accepted contraceptive methods (abstinence, intrauterine device, oral contraceptive, or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
  7. Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.

  8. Laboratory values ≤2 weeks must be:

    A. Adequate hematologic (platelet count ≥ 100,000 cells/mm^3 or ≥ 100 bil/L; absolute neutrophil count [ANC] ≥ 1500 cells/mm3 or ≥1.5 bil/L; and hemoglobin ≥ 9 g/dL or ≥ 90 g/L).

    B. Adequate hepatic function (aspartate aminotransferase [AST/SGOT] ≤ 3x upper normal limit [UNL], alanine aminotransferase [ALT/SGPT] ≤ 3x UNL (≤ 5x UNL if liver metastases present), Total bilirubin ≤ 1.5x ULN C. Adequate renal function (serum creatinine ≤ 2.0 mg/dL or 177 μmol/L). D. Adequate coagulation (International Normalized Ratio or INR must be ≤ 1.5), unless the patient receives anticoagulation treatment in which case the INR should be within the therapeutic level, not higher than 3.5 E. Albumin > 2.5 g/dL

  9. No evidence of active infection and no serious infection within the past month.

  10. Mentally competent, ability to understand and willingness to sign the informed consent form.

    -

Exclusion Criteria:

  1. Unwilling or unable to follow protocol requirements. Endocrine or acinar pancreatic carcinoma
  2. Known cerebral metastases, central nervous system (CNS), or epidural tumor
  3. Prior treatment with any systemic chemotherapy for metastatic adenocarcinoma of the pancreas or for stage III (locally advanced) adenocarcinoma
  4. Presence of clinically significant abdominal ascites
  5. Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment.
  6. Serious medical illness that would potentially increase patients' risk for toxicity.
  7. Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease).
  8. Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown).
  9. Lactating females.
  10. Fertile men unwilling to practice contraceptive methods during the study period.
  11. Life expectancy less than 3 months.
  12. Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.
  13. Unwilling or unable to follow protocol requirements.
  14. Active heart disease including but not limited to symptomatic congestive heart failure (NYHA class 3 or 4), symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction.
  15. Patients with a history of myocardial infarction that is <3 months prior to registration.
  16. Evidence of active infection, or serious infection within the past month.
  17. Patients with known HIV infection.
  18. Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment. Steroid use for contrast induced allergy or other supportive care indication is allowed
  19. Requirement for immediate palliative treatment of any kind including surgery.
  20. Any other malignancy within last 3 years
  21. History of interstitial lung disease, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis

  22. Peripheral neuropathy grades 2 or higher

    -

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: CPI-613, Gemcitabine and Nab-paclitaxel
CPI-613 in Combination With Gemcitabine 1000mg/m2 iv and Nab-paclitaxel 125mg/m2 iv
Drug: CPI 613 in Combination With Gemcitabine and Nab-paclitaxel

Day 1,15 CPI-613: IV infusion at a rate of 4 mL/min via a central venous catheter starting at 500 mg/m2 (with concurrent D5W infusing at a rate of 125-150 cc/hr). The CPI dose will be determined based on cohort. Day 2,16 Neulasta as clinically indicated

Nab- paclitaxel 125mg/m2 iv over 30 min followed by Gemcitabine 1000mg/m2 iv over 30 min

Other Names:
  • Gemzar
  • Gemcitabine
  • Abraxane
  • Nab-paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The maximally tolerated dose of CPI 613 combined with Gemcitabine and nab-paclitaxel
Time Frame: Evaluation at monthly intervals through study completion from the date of study entry until the date of progression, up to 1 year
Evaluation at monthly intervals through study completion from the date of study entry until the date of progression, up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of participants with treatment related adverse events as assessed by CTCAE v 4.0
Time Frame: Evaluation at 2 week intervals through study completion from the date of study entry until the date of progression, up to 1 year
Evaluation at 2 week intervals through study completion from the date of study entry until the date of progression, up to 1 year
The number of participants with complete or partial response
Time Frame: Evaluation at 2 month intervals through study completion from the date of study entry until the date of progression, up to 1 year
Evaluation at 2 month intervals through study completion from the date of study entry until the date of progression, up to 1 year

Collaborators and Investigators

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

Sponsor

Atlantic Health System

Collaborators

Cornerstone Pharmaceuticals

Investigators

  • Principal Investigator: Angela T Alistar, MD, Morristown Medical Center

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)

October 19, 2017

Primary Completion (ANTICIPATED)

November 1, 2018

Study Completion (ANTICIPATED)

January 1, 2019

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

February 9, 2018

First Posted (ACTUAL)

February 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA CPI 613

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual data available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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