Clinical trial · Interventional
Treating Patients With Advanced Solid Tumors, Breast Cancer or Recurrent Ovarian Cancer
A Phase I Scientific Exploratory Study of Epothilone B Analog in Patients With Solid Tumors and Gynecological Malignancies
NCT00005807CI-TRIAL-00035192BMS-247550completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have metastatic, recurrent, or locally advanced, ovarian cancer, breast cancer, or metastatic or unresectable solid tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-247550 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treated Participants
- description
- dose escalation treatment
- interventionNames
- Drug: BMS-247550
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed metastatic or unresectable solid malignancy for which no standard or curative therapies exist or are no longer effective * Metastatic, recurrent, or locally advanced breast, ovarian, or other cancer * Hemoglobin at least 9.0 g/dL * WBC at least 3,000/mm3 * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Bilirubin normal * AST/ALT no greater than 3 times upper limit of normal * Gilbert's syndrome allowed * Creatinine no greater than 2 mg/dL Exclusion Criteria: * symptomatic congestive heart failure * unstable angina pectoris * cardiac arrhythmia * grade 2 or greater clinical neuropathy * prior allergy or hypersensitivity reaction (grade 2 or greater) to prior paclitaxel or other therapy containing Cremophor EL * allergy or intolerance to steroids, diphenhydramine, cimetidine, or ranitidine * uncontrolled concurrent illness * active infection * pregnant or nursing * other concurrent anticancer therapies or commercial agents * other concurrent investigational agents * other concurrent highly active antiretroviral therapy for HIV-positive patients
References
Publications (1)
- RESULTMcDaid HM, Mani S, Shen HJ, Muggia F, Sonnichsen D, Horwitz SB. Validation of the pharmacodynamics of BMS-247550, an analogue of epothilone B, during a phase I clinical study. Clin Cancer Res. 2002 Jul;8(7):2035-43. PMID 12114401