Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
NCT ID: NCT00298675
Last Updated: 2012-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2006-03-31
2011-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Iniparib
BSI-201 (iniparib)
BSI-201 administered intravenously (IV), 2x weekly
Iniparib/irinotecan
BSI-201 (iniparib)
BSI-201 administered intravenously (IV), 2x weekly
irinotecan
Irinotecan administered weekly, IV.
Interventions
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BSI-201 (iniparib)
BSI-201 administered intravenously (IV), 2x weekly
irinotecan
Irinotecan administered weekly, IV.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Research Site
New Haven, Connecticut, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Countries
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Other Identifiers
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20060101
Identifier Type: OTHER
Identifier Source: secondary_id
TED11483
Identifier Type: -
Identifier Source: org_study_id