Clinical Trials /

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

NCT03435289

Description:

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.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Unknown status

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: GA CPI 613
  • NCT ID: NCT03435289

Conditions

  • Pancreatic Cancer
  • Metastatic Pancreatic Cancer

Interventions

DrugSynonymsArms
CPI 613 in Combination With Gemcitabine and Nab-paclitaxelGemcitabine, Nab-paclitaxel, Abraxane, GemzarCPI-613, Gemcitabine and Nab-paclitaxel

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
CPI-613, Gemcitabine and Nab-paclitaxelOtherCPI-613 in Combination With Gemcitabine 1000mg/m2 iv and Nab-paclitaxel 125mg/m2 iv
  • CPI 613 in Combination With Gemcitabine and Nab-paclitaxel

Eligibility Criteria

        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

             -
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Atlantic Health System

Trial Keywords

  • Advanced Pancreatic Cancer

Last Updated

February 9, 2018