- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00298675
Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
A Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologically documented advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available. Additionally, the safety and tolerability and clinical response of BSI-201 + irinotecan will be investigated in patients with metastatic breast cancer in the phase 1b portion of the study.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Expanded Access
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States
- Research Site
-
-
Texas
-
Houston, Texas, United States
- Research Site
-
San Antonio, Texas, United States
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathologically documented, advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available.
- ECOG performance status of 0, 1, or 2
- Adequate hematological status
- Any prior toxicity from prior chemotherapeutic treatment recovered to grade 1 or grade 0
- 18 years of age or older
- Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
- For phase 1b portion only: metastatic breast cancer
Exclusion Criteria:
- Hematologic malignancies
- Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids
- Myocardial infarction within 6 months of study day 1, unstable angina, congestive heart failure with NYHA > class II, uncontrolled hypertension
- Known positive test for HIV or hepatitis C virus, or chronic active hepatitis
- Major surgery within 1 month of study day 1
- History of second neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary cancer with no known active disease present and no curative treatment administered for the last 3 years
- History of seizure disorder or currently on anti-seizure medication
- Systemic chemotherapy or radiation therapy within 28 days of study day 1
- Antibody therapy for treatment of underlying malignancy within 1 month of study day 1
- Evidence of liver disease shown by elevated enzymes
- Evidence of renal disease shown by serum creatinine > 1.5 x upper limit of normal
- Currently receiving platelet of GCF support for any medical condition
- Concurrent use of herbal medications taken with the intent to treat cancer
- Enrolled in or not yet completed at least 30 days since ending other investigational device or drug study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Iniparib
|
BSI-201 administered intravenously (IV), 2x weekly
Other Names:
|
Experimental: Iniparib/irinotecan
|
BSI-201 administered intravenously (IV), 2x weekly
Other Names:
Irinotecan administered weekly, IV.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose
Time Frame: After one cycle
|
After one cycle
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Response
Time Frame: 8 months
|
8 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TED11483
- 20060101 (Other Identifier: BiPar)
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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