Clinical Trial of Continuing Treatment for Patients Who Have Participated on a Prior Protocol Investigating Tanespimycin

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00779428
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 84
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary purpose of this study is to provide treatment to patients who have participated on a prior protocol investigating Tanespimycin (KOS-953,17-AAG)

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignancies	Drug: Tanespimycin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 2 Clinical Trial of Tanespimycin in Patients With Advanced Malignancies After Failure of Previous Anti-cancer Therapy Regimens Who Have Participated on a Prior Protocol Investigating Tanespimycin
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A1	Drug: Tanespimycin; Solution, IV This is a one arm study with the dose, frequency, and duration assigned as per previous protocol (KOS-953, 17-AAG); Other Names: BMS-722782

Outcome Measures

Primary Outcome Measures

1. There is no Primary Outcome [No formal analysis of efficacy will occur]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >= 18 years

• Participated in and completed a previous Tanespimycin protocol without evidence of unacceptable toxicity and is deemed by the Investigator to be deriving benefit from the Tanespimycin drug as defined in the previous protocol

• All patients must rollover to this continuation protocol within 30 days of the last dose of Tanespimycin in the previous protocol, unless previously approved by the Medical Monitor

• All Adverse Events from the prior protocol, must have resolved to NCI CTCAE (v. 3.0) Grade <= 2

• The following laboratory results, within 10 days of Tanespimycin administration:

• Hemoglobin >= 8 g/dL

• Absolute neutrophils count >= 1.0x 109 /L

• Platelet count >= 50 x 109 /L

• Serum bilirubin <= 2 x ULN

• AST <= 2.5 ULN

• Serum creatinine <= 2 x ULN

• ECOG performance status of 0, 1 or 2

• Signed informed consent

Exclusion Criteria:

• Pre-existing neuropathy of CTCAE Grade >= 3 due to any cause

• Documented hypersensitivity reaction of CTCAE Grade >= 3 to prior therapy containing Cremophor (for those patients receiving Tanespimycin Injection)

• Pregnant or breast-feeding women

• Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic), excluding Tanespimycin within 21 days prior to receipt of study medication

• Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115

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: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT00779428
• Other Study ID Numbers: CA200-002
• First Posted: Oct 24, 2008
• Last Update Posted: Oct 12, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Bristol-Myers Squibb: This is an open-label continuing treatment protocol in patients with advanced malignancies who will receive Tanespimycin
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Oct 12, 2015