A Phase I/II Open-Label Dose-Escalation Clinical Trial Of CPI-613 In Combination With Gemcitabine In Cancer Patients

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 Plan

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

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-05-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-03-19
First Submitted that Met QC Criteria 2009-05-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-03-21
First Posted (ACTUAL) 2009-05-22	Results First Posted N/A	Last Verified 2017-01

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Phase I, Arm A CPI-613 + Gemcitabine	DRUG: CPI-613 IV infusion of CPI-613 given on Days 1,4, 8, 11, 15, 18, of 28 day cycle in cancer patients. DRUG: Gemcitabine IV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in cancer patients.
EXPERIMENTAL: Phase II, Arm A CPI-613 + Gemcitabine	DRUG: CPI-613 IV infusion of CPI-613 given on Days 1, 4, 8, 11, 15, 18, of 28 day cycle in patients with pancreatic carcinoma. DRUG: Gemcitabine IV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in patients with pancreatic carcinoma.
ACTIVE_COMPARATOR: Phase II, Arm B Gemcitabine	DRUG: Gemcitabine IV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in patients with pancreatic carcinoma.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Phase I, Arm A

CPI-613 + Gemcitabine

DRUG: CPI-613

IV infusion of CPI-613 given on Days 1,4, 8, 11, 15, 18, of 28 day cycle in cancer patients.

DRUG: Gemcitabine

IV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in cancer patients.

EXPERIMENTAL: Phase II, Arm A

CPI-613 + Gemcitabine

DRUG: CPI-613

IV infusion of CPI-613 given on Days 1, 4, 8, 11, 15, 18, of 28 day cycle in patients with pancreatic carcinoma.

DRUG: Gemcitabine

IV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in patients with pancreatic carcinoma.

ACTIVE_COMPARATOR: Phase II, Arm B

Gemcitabine

DRUG: Gemcitabine

IV infusion of 1000 mg/m^2 of Gemcitabine given on Days 1, 8, and 15 of a 28 day cycle in patients with pancreatic carcinoma.

Primary Outcome Measures	Measure Description	Time Frame
To determine the safety and MTD of CPI-613, when used in combination with Gemcitabine, in cancer patients.		1 Year

Secondary Outcome Measures	Measure Description	Time Frame
To compare the safety and efficacy of CPI-613 Gemcitabine combination vs. Gemcitabine alone in patients with carcinoma of the pancreas.		1 year

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

For Stages 1 and 2 of the study, histologically documented unresectable primary or metastatic carcinoma of the pancreas, Stage II-IV, diagnosed within the past 8 weeks, intended to be treated with Gemcitabine as a single agent at 1000 mg/m^2 once weekly for 3 weeks repeating the cycle every 4 weeks. For Stage 1 but not Stage 2 of the study, patients also include those with histologically documented unresectable primary or metastatic carcinoma other than pancreatic carcinoma (e.g., bladder cancer, NSCLC, and biliary tract cancer) who are intended to be treated with Gemcitabine as a single agent at 1000 mg/m^2 once weekly for 3 weeks repeating the cycle every 4 weeks, regardless if Gemcitabine is used as second, third or fourth line treatment.
Eastern Cooperative Oncology Group (ECOG) performance status being 0-2.
Expected survival >2 months.
18-70 years of age of both genders
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], 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.
No radiotherapy, treatment with cytotoxic agents or chemotherapeutic agents (except CPI-613), or treatment with biologic agents within the 2 weeks prior to treatment with CPI-613. At least 2 weeks must have elapsed from any prior surgery or hormonal therapy. Patients must have fully recovered from the acute toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment). Patients with persisting, stable chronic toxicities from prior treatment ≤Grade 1 are eligible, but must be documented as such.
Laboratory values ≤2 weeks must be:

Adequate hematologic (white blood cell [WBC] ≥3500 cells/mm^3 or ≥3.5 bil/L; platelet count ≥150,000 cells/mm^3 or ≥150 bil/L; absolute neutrophil count [ANC] ≥1500 cells/mm3 or ≥1.5 bil/L; and hemoglobin ≥9 g/dL or ≥90 g/L).
Adequate hepatic function (aspartate aminotransferase [AST/SGOT] ≤3x upper normal limit [UNL], alanine aminotransferase [ALT/SGPT] ≤3x UNL (≤5x UNL if liver metastases present), bilirubin ≤3x UNL).
Adequate renal function (serum creatinine ≤2.0 mg/dL or 177 µmol/L).
Adequate coagulation (International Normalized Ratio or INR must be≤1.5)
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.

Prior therapy with Gemcitabine
Serious medical illness, such as significant cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patients' risk for toxicity.
Patients with active central nervous system (CNS) or epidural tumor.
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 2 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.
Dyspnea with minimal to moderate exertion. Patients with large pleural, pericardial, or peritoneal effusions.
Active heart disease including myocardial infarction within previous 6 months, symptomatic coronary artery disease, arrhythmias requiring medication, or symptomatic congestive heart failure.
Albumin <2.5 g/dL or <25 g/L.
Evidence of active infection, or serious infection within the past month.
Patients with known HIV infection.
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 4 weeks prior to initiation of CPI-613 treatment.
Patients who have received immunotherapy of any type within the past 4 weeks prior to initiation of CPI-613 treatment.
Requirement for immediate palliative treatment of any kind including surgery.
Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months.
A marked baseline prolongation of QT/QTc interval (e.g., repeated exhibition of a QTc interval >470 ms.)
A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Prior illicit drug addiction.
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient.

Collaborators and Investigators

Publications

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