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

Phase 2

Completed

• Conditions: Advanced Malignancies
• Interventions: Drug: Tanespimycin

• Registration Number: NCT00779428
• Lead Sponsor: Bristol-Myers Squibb

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Primary Completion: 2013-03
• Study Completion: 2013-07
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 10*9* /L
• Platelet count >= 50 x 10*9* /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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A1	Tanespimycin	-

Primary Outcome Measures

Name	Time	Method
There is no Primary Outcome	No formal analysis of efficacy will occur

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States