Clinical trial · Interventional
BMS-214662 in Treating Patients With Solid Tumors
Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC 710086D) in Solid Tumors
NCT00005973CI-TRIAL-00009042completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase I trial to study the effectiveness of BMS-214662 in treating patients who have solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-214662 | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- 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.
- interventionNames
- Drug: BMS-214662
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- 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
- timeFrame
- Up to 6 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.