Clinical trial NCT00605618: Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors
Official title: A Phase I/II Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Safety and efficacy assessment including vitals signs, physical assessments, and blood tests
timeFrame: will be conducted weekly for the first 3 weeks then every 3 weeks. All assessments will continue for at least 24 months
measure: Tumor assessments
timeFrame: will be conducted every 6 weeks. All assessments will continue for at least 24 months
Secondary outcomes:
measure: Pharmacokinetics (PK) of BMS-777607 and its N-oxide metabolite, BMS-797669
timeFrame: will be assessed once weekly for the first 3 weeks
measure: The effects of BMS-777607 on blood pressure (BP), heart rate (HR)
timeFrame: will be assessed once weekly for the first 3 weeks then every 3 weeks
measure: Effects on electrocardiogram (ECG), PR interval
timeFrame: will be assessed at base line, at week 3 and at end of treatment
measure: Effects on left ventricular function
timeFrame: will be assessed at baseline and every 3 weeks for 1st 6 weeks then once every 6 months
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Kogarah
country: Australia
facility: Local Institution
state: New South Wales
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: