Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00605618

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Part A: The purpose of this study is to find the maximum tolerated dose of BMS-777607 in subjects with advanced or metastatic solid tumors

Part B: The purpose of this study is to describe the preliminary activity of BMS-77607 in subjects with advanced or metastatic gastroesophageal cancer, hormone refractory prostate cancer, head and neck squamous cell carcinoma, and type I papillary renal cell carcinoma

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: BMS-777607	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I/II Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm	Drug: BMS-777607 Suspension/Tablet, Oral, Dose escalation to an MTD from a starting dose of 10 mg, once daily, until disease progression/subject discontinuation

Arm

Intervention/Treatment

Experimental: Single Arm

Drug: BMS-777607

Suspension/Tablet, Oral, Dose escalation to an MTD from a starting dose of 10 mg, once daily, until disease progression/subject discontinuation

Outcome Measures

Primary Outcome Measures

Safety and efficacy assessment including vitals signs, physical assessments, and blood tests [will be conducted weekly for the first 3 weeks then every 3 weeks. All assessments will continue for at least 24 months]
Tumor assessments [will be conducted every 6 weeks. All assessments will continue for at least 24 months]

Secondary Outcome Measures

Pharmacokinetics (PK) of BMS-777607 and its N-oxide metabolite, BMS-797669 [will be assessed once weekly for the first 3 weeks]
The effects of BMS-777607 on blood pressure (BP), heart rate (HR) [will be assessed once weekly for the first 3 weeks then every 3 weeks]
Effects on electrocardiogram (ECG), PR interval [will be assessed at base line, at week 3 and at end of treatment]
Effects on left ventricular function [will be assessed at baseline and every 3 weeks for 1st 6 weeks then once every 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Part A:

Subjects with advanced or metastatic solid tumors who have either progressed on standard therapy or for whom standard therapy is not known

Part B:

Subjects with advanced or metastatic gastroesophageal cancer, HRPrC, HNSCC, or PRCC who have either progressed on standard therapy, or for whom standard therapy is not known. Eighteen (18) subjects each with gastroesophageal cancer, HRPrC, and HNSCC will be treated. Subjects with PRCC (up to 18) will be enrolled as feasible
Tumor paraffin tissue block or 6-10 unstained slides from the tumor tissue block must be provided
Subjects with HRPrC must have either measurable disease or rising PSA levels (≥3 consecutive rising levels with at least 1 week interval and with PSA level ≥5 mg/ml). All other subjects must have measurable disease as assessed by CT or MRI

Exclusion Criteria:

Know brain metastases
Uncontrolled or significant cardiovascular disease
Retinal atrophy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Camperdown	New South Wales	Australia	2050
2	Local Institution	Kogarah	New South Wales	Australia	2217

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00605618

Other Study ID Numbers:

CA192-002

First Posted:

Jan 31, 2008

Last Update Posted:

Jan 25, 2011

Last Verified:

Aug 1, 2009

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Jan 25, 2011