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Safety and Effectiveness Study of CPI-613 and/or Gemcitabine to Treat Metastatic Pancreatic Cancer

Information source: Cornerstone Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Pancreatic Adenocarcinoma

Intervention: CPI-613 (Drug); Gemcitabine (Drug); Any non-gemcitabine chemotherapies or best supportive care (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Cornerstone Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
King C Lee, Ph.D., Study Chair, Affiliation: Cornerstone Pharmaceuticals, Inc.


This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients with metastatic pancreatic cancer. The primary outcome measure is Overall Survival (OS). The secondary outcome measures are: changes in CA 19-9, Quality of Life (QOL), Progression-Free Survival (PFS), and safety.

Clinical Details

Official title: A Phase II Open-Label Clinical Trial of CPI-613 Given Alone, or in Combination With Gemcitabine, in Patients With Metastatic Pancreatic Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival (OS)

Secondary outcome:

Changes in CA 19-9

Quality of Life (QOL)

Progression-Free Survival (PFS)


Detailed description: Data from dose-escalated Phase I trials indicate that CPI-613 is safe and effective against metastatic pancreatic cancer (Lee et al. 2012; Retter et al. 2012). Accordingly, this Phase II trial is conducted to assess the safety and efficacy of CPI-613 in patients with metastatic pancreatic cancer. Primary Outcome Measure:

- Overall Survival (OS)

Secondary Outcome Measures:

- Changes in CA 19-9

- Quality of Life (QOL) assessment

- Progression-Free Survival (PFS)

- Safety


Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.


Inclusion Criteria:

- Histologically and cytologically confirmed, measurable metastatic pancreatic


- Eastern Cooperative Oncology Group (ECOG) performance status being 0-2

- Expected survival >2 months

- 18 years of age or older 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. (Note: Pregnant patients are excluded because the effects of CPI-613 on a fetus are unknown.)

- Fertile men must practice effective contraceptive methods during the study, unless

documentation of infertility exists.

- At least 2 weeks must have elapsed from any prior surgery or hormonal therapy. Must

have fully recovered from the acute toxicities of any prior treatment with any anti-cancer 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/mm3 or ≥3. 5 bil/L;

platelet count ≥150,000 cells/mm3 or ≥150 bil/L; absolute neutrophil count [ANC] ≥1500 cells/mm3 or ≥1. 5 bil/L; and hemoglobin (Hgb) ≥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 ≤1. 5x UNL).

- Adequate renal function (serum creatinine ≤2. 0 mg/dL or 177 μmol/L, and blood

urea nitrogen [BUN] ≤25 mg/dL).

- Adequate coagulation ("International Normalized Ratio or INR must be <1. 5"),

unless treated with anticoagulants.

- No evidence of active infection and no serious infection within the past month; no

systemic fungal, bacterial, viral or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment.

- Consent to participating the study by signed informed consent form

Exclusion Criteria:

- Serious medical illness that would potentially increase patients' risk for toxicity

- Any active uncontrolled bleeding or patients with a bleeding diathesis (e. g., active

peptic ulcer disease)

- Patients with active central nervous system (CNS) or epidural tumor

- Lactating females (Note: Lactating females are excluded because the effects of

CPI-613 on a nursing child are unknown)

- Life expectancy less than 2 months

- Unwilling or unable to follow protocol requirements

- Dyspnea with minimal to moderate exertion, or patients with pleural, pericardial, or

peritoneal effusions

- Active heart disease including but not limited to symptomatic congestive heart

failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction, arrhythmias requiring medication, or symptomatic congestive heart failure. Also patients with a history of myocardial infarction that is <1 year prior to registration, or patients with previous congestive heart failure (<1 year prior to registration) requiring pharmacologic support or with Left Ventricular Ejection Fraction <50%).

- 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).

- Requirement for immediate palliative treatment of any kind including surgery

- Any condition or abnormality which may, in the opinion of the investigator,

compromise the safety of patients

Locations and Contacts

Eastchester Center for Cancer Care, Bronx, New York 10469, United States

Temple Vasicek Cancer Treatment Center, Temple, Texas 76508, United States

Additional Information

Starting date: January 2014
Last updated: August 13, 2013

Page last updated: August 23, 2015

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