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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00792558
Other study ID # CA195-001
Secondary ID
Status Withdrawn
Phase Phase 1
First received November 17, 2008
Last updated August 31, 2015
Start date January 2009
Est. completion date November 2010

Study information

Verified date January 2009
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods AdministrationSingapore: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
BMS-817378
Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation

Locations

Country Name City State
Australia Local Institution Adelaide South Australia
Australia Local Institution Nedlands Western Australia
Singapore Local Institution Singapore

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Australia,  Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833 Days 1 and 15 No
Secondary 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 Yes
Secondary Describe preliminary evidence for anti-tumor activity of BMS-817378 Every 6 weeks No
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