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NCT00207103
Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
Phase 1 trial testing Brivanib in Tumors in 68 participants. Completed in 1 September 2008.
1 October 2007
Quick facts
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 68 |
| Start date | 1 September 2004 |
| Primary completion | 1 October 2007 |
| Estimated completion | 1 September 2008 |
| Sites | 8 locations across United States, Canada, Italy, United Kingdom |
Drugs / interventions tested
- Brivanib — full drug profile →
- Brivanib — full drug profile →
- Brivanib — full drug profile →
- Brivanib — full drug profile →
- Brivanib — full drug profile →
- Brivanab — full drug profile →
Conditions studied
- Tumors — all drugs for Tumors →
- Neoplasm Metastasis — all drugs for Neoplasm Metastasis →
Sponsor
Bristol-Myers Squibb — full company profile →
Who can join
18 and older, any sex, with Tumors or Neoplasm Metastasis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety assessment
Time frame: throughout the study -
dose-limiting toxicity (DLT)
Time frame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified -
determination of maximum tolerated dose (MTD)
Time frame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
Sponsor's own description
This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00207103
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Brivanib
Trials testing the same drug.
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- NCT00825955 — Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Fai · Phase 3 · completed
Other recruiting trials for Tumors
Currently open trials in the same condition.
- NCT05697406 — HP Pyruvate MRI in Cancers · Phase 1, PHASE2 · recruiting
- NCT05103358 — Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 G · Phase 2 · active not recruiting
- NCT05103969 — Cohort of Tumors With POLE/D1 Mutation · recruiting
- NCT04950959 — XACT ACE Observational Registry · recruiting
- NCT04341181 — ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling · Phase 2 · recruiting
Other Bristol-Myers Squibb trials
Trials by the same sponsor.
- NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
- NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
- NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
- NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
- NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00207103 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
- Last refreshed: 3 November 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00207103.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing