Clinical trial · Interventional
A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors
A Phase I Dose Escalation Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors
NCT00329004CI-TRIAL-00004341completedPhase 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)
The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-690514 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: BMS-690514
Primary outcomes (2)
- measure
- Safety
- timeFrame
- results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks
- measure
- Highest dose tolerated
- timeFrame
- continuous medical review of adverse event reports
Secondary outcomes (1)
- measure
- Effective dose or doses of BMS-690514
- timeFrame
- tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women 18 and older * Diagnosis of any solid tumor * ECOG performance status score 0-1 * Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment * Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both) Exclusion Criteria: * Treatment with other TKIs within the past 4 weeks * Patients with brain metastasis * Patients with centrally located squamous cell carcinoma of the lung * Major gastrointestinal surgery which may affect absorption of the drug * Any surgery within last 4 weeks * History of thromboembolism * Severe unmanageable diarrhea * Subjects in Part B will have Non-Small Cell Lung Cancer (NSCLC) * Part B/Cohort I erlotinib-naive subjects * Part B/Cohort II subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)
References
Publications (1)
- DERIVEDSoria JC, Baselga J, Hanna N, Laurie SA, Bahleda R, Felip E, Calvo E, Armand JP, Shepherd FA, Harbison CT, Berman D, Park JS, Zhang S, Vakkalagadda B, Kurland JF, Pathak AK, Herbst RS. Phase I-IIa study of BMS-690514, an EGFR, HER-2 and -4 and VEGFR-1 to -3 oral tyrosine kinase inhibitor, in patients with advanced or metastatic solid tumours. Eur J Cancer. 2013 May;49(8):1815-24. doi: 10.1016/j.ejca.2013.02.012. Epub 2013 Mar 13. PMID 23490650