Clinical trial · Interventional
BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors
Phase I Study of Intravenous BMS-214662 FTI (NSC# 710086) and Herceptin (NSC# 688097) Weekly in Patients With Advanced Malignancies
NCT00022529CI-TRIAL-00009144completedPhase 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 plus trastuzumab in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells
Conditions
Conditions (1)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-214662 | Drug | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (BMS-214662, trastuzumab)
- description
- Patients receive BMS-214662 IV over 1 hour on days 2, 8, 15, and 22 and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: BMS-214662
- Biological: trastuzumab
- Other: pharmacological study
Primary outcomes (1)
- measure
- MTD defined as the highest dose level at which =< 1/6 subjects experience a study related dose-limiting toxicity (DLT) as assessed by CTC version 2.0
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective therapy exists * Overexpressing HER-2-neu (2+ or 3+) by immunohistochemistry or fluorescent in situ hybridization * Clinically or radiologically evaluable disease * No carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease * At least 8 weeks since prior therapy for prior brain parenchymal disease and asymptomatic off corticosteroids * Performance status - ECOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.8 mg/dL * ALT and AST no greater than 1.5 times upper limit of normal (ULN) * Creatinine no greater than 1.5 times ULN * No uncontrolled or significant cardiovascular disease * No myocardial infarction within the past 6 months * No prior clinically significant atrial or ventricular arrhythmias * No prior second or third degree heart block * No ischemic heart disease requiring medication * No congestive heart failure * Corrected QT interval no greater than 450 milliseconds by electrocardiogram * Ejection fraction at least lower limit of normal by MUGA scan * No uncontrolled or significant pulmonary disease * No active unresolved infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study * At least 4 weeks since prior immunotherapy, including trastuzumab (Herceptin), and recovered * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No anthracyclines for at least 22 weeks after completion of study therapy * No other concurrent chemotherapy * Concurrent hormone replacement therapy allowed * No other concurrent hormonal therapy * At least 4 weeks since prior radiotherapy and recovered * No prior radiotherapy to more than 25% of the bone marrow-containing skeleton * No concurrent radiotherapy * At least 4 weeks since prior investigational agents and recovered * At least 7 days since prior known substrates of cytochrome P450-3A4 (CYP3A4) * At least 7 days since prior parenteral antibiotics * No concurrent substrates of CYP3A4 * No concurrent parenteral antibiotics * No other concurrent experimental medications
References
Publications (0)
Data not yet available
No reference posted for this study.