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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00779428

Purpose

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	Intervention	Phase
Advanced Malignancies	Drug: Tanespimycin	Phase I Phase II

MedlinePlus related topics: Cancer

Drug Information available for: IPI-504 17-(Allylamino)-17-demethoxygeldanamycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

There is no Primary Outcome [ Time Frame: No formal analysis of efficacy will occur ] [ Designated as safety issue: No ]

Estimated Enrollment:	6
Study Start Date:	August 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779428

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States, 15224

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol Myers Squibb ( Study Director )
Study ID Numbers:	CA200-002
Study First Received:	October 23, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00779428
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on January 14, 2009