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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 January 2013 |
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Main ID: |
NCT00005973 |
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Date of registration:
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05/07/2000 |
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Primary sponsor: |
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Public title:
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BMS-214662 in Treating Patients With Solid Tumors
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Scientific title:
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Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC 710086D) in Solid Tumors |
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Date of first enrolment:
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April 2000 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00005973 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Vassiliki Papadimitrakopoulou |
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Address:
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Telephone:
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Email:
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Affiliation:
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M.D. Anderson Cancer Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Unspecified Adult Solid Tumor, Protocol Specific
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Unspecified Childhood Solid Tumor, Protocol Specific
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Intervention(s)
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Drug: BMS-214662
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Other: laboratory biomarker analysis
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Primary Outcome(s)
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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]
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Secondary ID(s)
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CDR0000067960
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ID99-304
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NCI-2012-02343
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U01CA062461
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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