- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01333137
A Clinical Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin
September 3, 2014 updated by: Piramal Enterprises Limited
An Open-Label Randomized Phase II Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Phase I Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin
P276-00 is a novel, potent, small-molecule, flavone-derived Cdk 4 D1, Cdk1 B, and Cdk9 T inhibitor, with potent cytotoxic effects against chemosensitive and chemoresistant cancer cell lines.This study is planned to compare efficacy of the standard chemotherapy regimen of gemcitabine and carboplatin when administered with or without P276-00 in subjects with advanced triple negative breast cancer.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Burbank, California, United States
- Disney Cancer Center
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La Jolla, California, United States, 92093
- 3855 Health Sciences Drive
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Sacramento, California, United States, 95817
- UC Davis Cancer Center
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Missouri
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St. Louis, Missouri, United States
- Washington University
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Females of age ≥18 years.
- Histologically documented metastatic triple negative breast cancer (any triple negative breast cancer for Phase I)
- Two or fewer chemotherapy regimens for advanced disease (no limit of prior regimens for Phase I)
- ECOG performance score of 1 or less
- Presence of measurable disease by RECIST 1.1 criteria (not for the Phase I portion)
- Ability to understand and the willingness to sign a written informed consent document (ICD)
- Full recovery from all prior treatment toxicities to Common Terminology Criteria for Adverse Events (CTCAE V.4) Grade ≤ 1
Exclusion Criteria:
- Prior chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration
- Prior radiation therapy within 6 weeks of study drug administration
- Subject with known active CNS metastases and/or carcinomatous meningitis. However, subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases (2) off steroids that are used to minimize surrounding brain edema.
- Prior therapy with gemcitabine or a platinum agent (not for the Phase I part)
- Prior therapy with a Cdk/cyclin inhibitor or any flavones derivative
- QTc interval >450 msec (using Fridericia's formula)
- Any acute illness including uncontrolled diabetes, symptomatic or otherwise uncontrolled cardiac disease (coronary artery disease, arrhythmias, congestive heart failure) or other illness that in the judgment of the investigator would introduce additional medical risks
- Visceral crisis including extensive liver disease with>50% parenchymal involvement or lymphangitic pulmonary disease
- History of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, or in situ breast cancer
- Expected survival of less than 3 months
- Hemoglobin <9.0 gm/dL
- Absolute neutrophil count <1500/mm3
- Platelet count <100,000/mm3
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >3 × institutional upper limit of normal (ULN)
- Total bilirubin, >1.5 × institutional ULN
- Serum creatinine >1.5 mg/dL
- Subjects with known infection with human immunodeficiency virus (HIV), tuberculosis, Hepatitis C or Hepatitis B
- Pregnant or lactating women
Women of childbearing potential not willing to use approved methods of contraception after signing the ICD, during the entire study and for at least 4 weeks after completion of study or following withdrawal from the study
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Gemcitabine and Carboplatin
Gemcitabine 1000 mg/m2/day on Days 1 & 8 and carboplatin at AUC 2 on Days 1 and 8 every 21 days.
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Gemcitabine 1000 mg/m2/day on Days 1 & 8 and carboplatin at AUC 2 on Days 1 and 8 every 21 days.
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Experimental: P276-00 along with Gemcitabine and carboplatin
P276-00 will be administered at starting dose of 100 mg/m2/day (and higher if tolerated) in 200 mL of 5% dextrose as an iv infusion over 30 minutes, on Days 1 to 5, along with gemcitabine 1000 mg/m2/day and carboplatin at AUC 2 on Days 1 & 8 every 21 days.In Phase 2 component, P276-00 will be administered at recommended phase II dose of P276-00 in combination with standard dose of gemcitabine and carboplatin.
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In phase I run in period, P276 00 will be administered at starting dose of 100 mg/m2/day (and higher if tolerated) in 200 mL of 5% dextrose as an iv infusion over 30 minutes, on Days 1 to 5, along with gemcitabine 1000 mg/m2/day and carboplatin at AUC 2 on Days 1 & 8 every 21 days.
In Phase 2 component, P276-00 will be administered at recommended phase II dose of P276-00 in combination with standard dose of gemcitabine and carboplatin.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Progression free survival
Time Frame: 1 year and above
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The primary efficacy endpoint will be median progression-free survival (PFS), defined as the time from the beginning of study treatment to the occurrence of documented disease progression or recurrence, or death from any cause
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1 year and above
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS)
Time Frame: at 3 years
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at 3 years
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Overall survival at 6 months
Time Frame: at 6 months
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at 6 months
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Progression Free Survival at 6 months
Time Frame: at 6 months
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at 6 months
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Objective response rate
Time Frame: upto 3 years and above
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upto 3 years and above
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Duration of response
Time Frame: upto 3 years and above
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upto 3 years and above
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr.Debasish Tripathy, USC/Norris Comprehensive Cancer Center 1441 Eastlake Avenue, Rm 3440, Los Angeles, CA 90033
Study record dates
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 Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
April 8, 2011
First Submitted That Met QC Criteria
April 8, 2011
First Posted (Estimate)
April 11, 2011
Study Record Updates
Last Update Posted (Estimate)
September 4, 2014
Last Update Submitted That Met QC Criteria
September 3, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Triple Negative Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Carboplatin
Other Study ID Numbers
- P276-00/52/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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