Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers

A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00792558

Enrollment

Registered

2008-11-18

Start date

2009-01-31

Completion date

2010-11-30

Last updated

2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Brief summary

The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers

Interventions

DRUGBMS-817378

Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Confirmed diagnosis of advanced non-hematologic malignancy. Dose expansion cohort restricted to subjects with advanced or metastatic gastroesophageal cancer, squamous cell cancers of the head and neck, and castration resistant prostate cancer * ECOG status 0-1

Exclusion criteria

* WOCBP unwilling/unable to use acceptable contraception methods, and women pregnant or breast feeding * Symptomatic brain metastasis * Uncontrolled or significant cardiovascular disease * History of thromboembolic events or bleeding diathesis in past 6 months * Conditions requiring prophylactic anticoagulation or chronic anti-platelet therapy * Serious non-healing wounds, ulcers or bone fractures in past 3 months * Hemorrhage or bleeding event \>= CTCAE grade 3 in past 4 weeks * Proteinuria \>= 2+ on dipstick or \>= 1gm/24 hours * Concurrent chemotherapy, hormonal therapy, immunotherapy, radiation therapy or therapy with any other investigational product * Concurrent herbal, alternative, food supplements, or strong CYP 3A4 inhibitors or inducers

Design outcomes

Primary

Measure	Time frame
To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers	Within the first 21 days after first dose of BMS-817378

Secondary

Measure	Time frame
Assess safety and tolerability of multiple doses of BMS-817378 administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors	All time points while subject is on study
Assess the safety and tolerability of co-administration of a CYP substrate cocktail and BMS-817378 given at or below the MTD (dose expansion cohort)	Day 22 +/-2
Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833	Days 1 and 15
Assess the effects of BMS-817378 and BMS-794833 on blood pressure, heart rate, ECG intervals, and left ventricular ejection fraction	All time points while subject is on study
Describe preliminary evidence for anti-tumor activity of BMS-817378	Every 6 weeks

Countries

Australia, Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026