Clinical trial · Interventional
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors
A Phase I Multiple Ascending Dose Study of BMS-754807 in Subjects With Advanced or Metastatic Solid Tumors
NCT00569036CI-TRIAL-00011768completedPhase 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)
This is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 for Phase 2 studies
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 |
|---|---|---|---|
| Metastases | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-754807 | Drug | Dual IGF-1R/InsR Inhibitor BMS-754807 | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BMS-754807
- description
- Single arm, multiple-ascending dose escalation study
- interventionNames
- Drug: BMS-754807
Primary outcomes (1)
- measure
- Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
- timeFrame
- Continuous assessment throughout the duration of the trial
Secondary outcomes (5)
- measure
- Pharmacokinetics
- timeFrame
- assessed during the first 4 weeks of the study
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
* ECOG performance status 0-1
* at least 4 weeks between surgery or last dose prior anti-cancer therapy
Exclusion Criteria:
* symptomatic brain metastases
* any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
* uncontrolled or significant cardiovascular disease
* inadequate bone marrow, liver or kidney functionReferences
Publications (0)
Data not yet available
No reference posted for this study.