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

Study Overview
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Brief Summary
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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

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

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: BMS-777607


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |