Clinical trial · Interventional
BMS-599626 in Treating Patients With Metastatic Solid Tumors
Phase I Study Of BMS-599626 In Patients With Advanced Solid Malignancies That Express Her2
NCT00093730CI-TRIAL-00008204completedPhase 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: BMS-599626 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I trial is studying the side effects and best dose of BMS-599626 in treating patients with metastatic solid tumors.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-59926 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BMS-59926
- interventionNames
- Drug: BMS-59926
Primary outcomes (1)
- measure
- maximum tolerated dose of BMS-599626
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed primary solid (i.e., non-hematologic) tumor
* Radiographic or tissue confirmation of metastatic disease
* Locally advanced disease allowed if no surgical or local therapeutic treatment exists
* HER2/neu overexpression (1+, 2+, or 3 +) by immunohistochemistry
* Tumors with HER2 gene amplification by fluorescence in situ hybridization analysis allowed
* Tumor paraffin tissue block OR 20-30 unstained slides from tumor tissue block must be available for biomarker and predictive marker analyses
* Disease progression during or after standard therapy OR no standard therapy exists
* Measurable or non-measurable disease
* Measurable disease is required for the expanded cohort treated at the maximum tolerated dose of the study drug
* No known brain metastasis
* Patients with controlled brain metastasis with no disease progression 60 days after prior therapy and no neurologic signs or symptoms are allowed
* Patients with signs or symptoms suggestive of brain metastasis are eligible provided that brain metastasis is ruled out by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT and AST ≤ 2.5 times ULN
* PT/PTT ≤ 1.5 times ULN
* INR ≤ 1.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
* Calcium normal
Cardiovascular
* LVEF ≥ 45%
* Heart rate ≥ 50 beats/min on electrocardiogram
* No uncontrolled cardiovascular disease
* No myocardial infarction within the past 12 months
* No uncontrolled angina within the past 6 months
* No congestive heart failure within the past 6 months
* No prolonged QTc (\> 450 msec) on electrocardiogram
* No diagnosed or suspected congenital long QT syndrome
* No history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
* No history of second- or third-degree heart block
* Patients with pacemakers may be eligible
* No uncontrolled hypertension
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study participation
* Potassium normal
* Magnesium normal
* No medical condition that has a risk of causing torsades de pointes
* No active infection
* No serious uncontrolled medical disorder that would preclude study participation
* No dementia or altered mental status that would preclude giving informed consent
* No known allergy to BMS-599626 or related compound
* No prisoners or patients involuntarily incarcerated for treatment of either a psychiatric or physical (e.g., infectious disease) illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 4 weeks since prior immunotherapy
* At least 2 weeks since prior targeted kinase inhibitor (e.g., trastuzumab \[Herceptin\^®\])
Chemotherapy
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome)
Endocrine therapy
* At least 2 weeks since prior anticancer hormonal therapy
Radiotherapy
* At least 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* Recovered from prior therapy
* Prior adjuvant or neoadjuvant therapy allowed
* No short-acting antacids (e.g., Maalox\^® or TUMS\^®) 8 hours before or 4 hours after study drug administration
* No recent anticancer therapy
* More than 4 weeks since prior investigational agents
* At least 5 days (or 5 half-lives) since prior drugs that cause torsades de pointes
* At least 48 hours since prior proton pump inhibitors (e.g., omeprazole or lansoprazole) or histamine H\_2 antagonists (e.g., ranitidine, famotidine, or cimetidine)
* Concurrent low-dose coumadin allowed
* No other concurrent investigational agents
* No concurrent drugs that may cause torsades de pointes or QTc prolongationReferences
Publications (0)
Data not yet available
No reference posted for this study.