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

Advanced Malignancies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779428
• Other study ID #: CA200-002
• Status: Completed
• Phase: Phase 2
• First received: October 23, 2008
• Last updated: September 23, 2015
• Start date: July 2006
• Est. completion date: July 2013

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

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

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms

Intervention

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)

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	There is no Primary Outcome		No formal analysis of efficacy will occur	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