- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005973
BMS-214662 in Treating Patients With Solid Tumors
Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC 710086D) in Solid Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
I. Determine the maximum tolerated dose of BMS-214662 in patients with solid tumors.
II. Evaluate intermediate biological endpoints as surrogates for the effectiveness of this drug in these patients.
III. Determine the nature of dose limiting toxicity of this drug in this patient population.
IV. Determine the recommended phase II regimen of this drug in these patients. V. Establish a pharmacologic and pharmacokinetic profile of this drug in these patients.
OUTLINE: This is a dose escalation study.
Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities.
Patients are followed every 3 months for at least 24 months.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of malignant solid tumor for which a standard curative therapy does not exist
- Performance status - Karnofsky 70-100%
- At least 6 months
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10.0 g/dL
- Bilirubin no greater than 2.0 mg/dL
- AST no greater than 2 times upper limit of normal
- Albumin at least 3.0 g/dL
- Creatinine no greater than 1.5 mg/dL
- No uncontrolled heart disease
- No history of clinically significant cardiac arrhythmia that could be exacerbated by QT interval prolongation
- Corrected QT interval no greater than 450 milliseconds
- Must not require total parenteral nutrition
- No manifestations of malabsorption syndrome due to prior surgery, gastrointestinal disease, or unknown reasons
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No signs or symptoms of acute infection requiring systemic therapy
- No grade 3 or 4 neurotoxicity from prior anticancer treatment or neuropathy from any cause
- No confusion, disorientation, or psychiatric illness that may preclude study
- No more than 3 prior chemotherapy regimens
- At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) and recovered
- No other concurrent antineoplastic agents
- No concurrent hormonal anticancer therapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
- Prior drugs known to prolong the QT interval allowed if they can be safely discontinued for a time period equal to 4 elimination half-lives prior to administering study drug
- No drugs known to prolong the QT interval during and for 24 hours after study drug
- No concurrent therapy with known CYP3A4 substrates
- No other concurrent investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MTD, defined as the dose level among the 9 levels studied having toxicity rate closest to a target of 33%, graded according to CTC version 2.0
Time Frame: Up to 6 weeks
|
Toxicity is defined as grade 3, 4 non-hematologic and grade 4 hematologic (neutropenia and thrombocytopenia) toxicity.
The continual reassessment method (CRM) will be used.
|
Up to 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vassiliki Papadimitrakopoulou, M.D. Anderson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary 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
- NCI-2012-02343
- U01CA062461 (U.S. NIH Grant/Contract)
- ID99-304
- CDR0000067960 (Registry Identifier: PDQ (Physician Data Query))
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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