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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605618
• Other study ID #: CA192-002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 18, 2008
• Last updated: January 24, 2011
• Start date: March 2008
• Est. completion date: March 2009

Study information

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

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

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

Locations

Country	Name	City	State
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Kogarah	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Tumor assessments		will be conducted every 6 weeks. All assessments will continue for at least 24 months	No
Secondary	Pharmacokinetics (PK) of BMS-777607 and its N-oxide metabolite, BMS-797669		will be assessed once weekly for the first 3 weeks	No
Secondary	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	No
Secondary	Effects on electrocardiogram (ECG), PR interval		will be assessed at base line, at week 3 and at end of treatment	No
Secondary	Effects on left ventricular function		will be assessed at baseline and every 3 weeks for 1st 6 weeks then once every 6 months	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form