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

Status unconfirmed · Phase 1

Conditions studied: Pancreatic Cancer, Metastatic Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT03435289

Run by

Atlantic Health System

People needed

24

Starts

2017-10-19

Expected to finish

2019-01-01

Last updated by the study team

2018-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically documented and measurable stage III or IV pancreatic adenocarcinoma.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• First line treatment for patients diagnosed with metastatic disease
• 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.
• Expected survival > 3 months.
• 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.
• Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
• 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
• No evidence of active infection and no serious infection within the past month.
• Mentally competent, ability to understand and willingness to sign the informed consent form.

You may not qualify if…

• Unwilling or unable to follow protocol requirements. Endocrine or acinar pancreatic carcinoma
• Known cerebral metastases, central nervous system (CNS), or epidural tumor
• Prior treatment with any systemic chemotherapy for metastatic adenocarcinoma of the pancreas or for stage III (locally advanced) adenocarcinoma
• Presence of clinically significant abdominal ascites
• 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.
• Serious medical illness that would potentially increase patients' risk for toxicity.
• Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease).
• Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown).
• Lactating females.
• Fertile men unwilling to practice contraceptive methods during the study period.
• Life expectancy less than 3 months.
• Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.
• Unwilling or unable to follow protocol requirements.
• 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.
• Patients with a history of myocardial infarction that is <3 months prior to registration.
• Evidence of active infection, or serious infection within the past month.
• Patients with known HIV infection.
• 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
• Requirement for immediate palliative treatment of any kind including surgery.
• Any other malignancy within last 3 years
• History of interstitial lung disease, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis
• Peripheral neuropathy grades 2 or higher

Where it is running

• Morristown Medical Center — Morristown, New Jersey, United States (enrolling)
• Overlook Medical Center — Summit, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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