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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: BMS-777607

• Registration Number: NCT00605618
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-18
• Study First Submitted QC: 2008-01-18
• Study First Posted: 2008-01-31
• Study Start: 2008-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-08
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	BMS-777607	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇦🇺 Kogarah, New South Wales, Australia