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COMPLETEDPHASE1

A Open Label Phase I/II Clinical Trial to Evaluate CPI-613 in Patients With Advanced Malignancies

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

NCT00741403•Cornerstone Pharmaceuticals

View on ClinicalTrials.gov

Summary

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 The objectives of this study are: * To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks. * To determine pharmacokinetics of CPI-613 following intravenous (IV) administration. * To observe the anti-tumor effects of CPI-613, if any occur.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 unknown.)
•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 such.
•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).
+3 more criteria

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.
+11 more criteria

Locations (4)

Pivotal Research Centers

Peoria, Arizona, United States

Eastchester Center for Cancer Care

The Bronx, New York, United States

Mary Crowley Cancer Research Centers

Dallas, Texas, United States

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Key Dates

Start Date

August 1, 2008

Primary Completion Date

December 1, 2016

Completion Date

December 1, 2016

Last Updated

December 29, 2016

Enrollment

ACTUAL participants

Conditions

Advanced CancerMetastatic CancerLymphomaSolid TumorsAdvanced Malignancies

Interventions

CPI-613

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Open Label Phase I/II Clinical Trial to Evaluate CPI-613 in Patients With Advanced Malignancies

Inclusion Criteria

Exclusion Criteria

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

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Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

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