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An Open Label, Dose-Escalation Study to Evaluate Safety, Tolerability, Maximum Tolerated Dose (MTD), Efficacy, and Pharmacokinetics (PKs) of CPI-613 Given Twice Weekly for Three Consecutive Weeks in Cancer Patients

Phase 1/Phase 2
18 Years
Open (Enrolling)
Advanced Cancer, Metastatic Cancer, Lymphoma, Solid Tumors, Advanced Malignancies

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Trial Information

An Open Label, Dose-Escalation Study to Evaluate Safety, Tolerability, Maximum Tolerated Dose (MTD), Efficacy, and Pharmacokinetics (PKs) of CPI-613 Given Twice Weekly for Three Consecutive Weeks in Cancer Patients

Inclusion Criteria:

- Patients must have advanced and/or metastatic, histologically or cytologically
documented solid tumors and lymphomas, for whom there is no available therapy shown
to provide clinical benefit.

- Karnofsky Performance Status (KPS) of >70%.

- Must be ≥18 years of age.

- Expected survival >3 months.

- 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), 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

- Fertile men must practice effective contraceptive methods during the study period,
unless documentation of infertility exists.

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

- No radiotherapy, treatment with cytotoxic agents (except CPI-613), or treatment with
biologic agents within the 3 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

- Laboratory values ≤2 weeks must be:

- Adequate hematologic (white blood cell [WBC] ≥3500 cells/mm^3 or ≥3.5 bil/L;
platelet count ≥100,000 cells/mm^3 or ≥100 bil/L; absolute neutrophil count
[ANC] ≥1500 cells/mm^3 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).

- Adequate coagulation (International Normalized Ratio or INR must be ≤1.25).

Exclusion Criteria:

- Serious medical illness, such as significant cardiac disease (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 because the potential of excretion of CPI-613 into breast milk.
(Note: Lactating females are excluded because the effects of CPI-613 on a nursing
child are unknown.)

- 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.

- Dyspnea with minimal to moderate exertion. Patients with large and recurrent
pleural, or peritoneal effusions requiring frequent drainage (e.g. weekly). Patients
with any amount of clinically significant pericardial effusion.

- 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 3 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., clinically
significant heart failure, hypokalemia, family history of Long QT Syndrome).

- Troponin I above institution limit of normal or Left Ventricular Ejection Fraction
(LVEF) below 35%.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety, tolerability, maximum tolerated dose (MTD), and efficacy pharmacokinetics of CPI-613 given twice weekly for three consecutive weeks in cancer patients

Outcome Time Frame:

October 2010

Safety Issue:


Principal Investigator

Karen Gelmon, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

December 2012

Related Keywords:

  • Advanced Cancer
  • Metastatic Cancer
  • Lymphoma
  • Solid Tumors
  • Advanced Malignancies
  • Phase I
  • Phase II
  • malignancies
  • refractory
  • relapsed
  • Neoplasms
  • Lymphoma
  • Neoplasm Metastasis
  • Neoplasms, Second Primary



Eastchester Center for Cancer CareBronx, New York  10469
Mary Crowley Cancer Research CentersDallas, Texas  75201
Pivotal Research CentersPeoria, Arizona  85381