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

NCT00779428 | Completed Phase 2

• 1 other identifier: CA200-002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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)

Conditions

Advanced Malignancies

Keywords

This is an open-label continuing treatment protocol in patients with advanced malignancies who will receive Tanespimycin

Outcome Measures

Primary Outcomes (1)

• There is no Primary Outcome

  No formal analysis of efficacy will occur

Study Arms (1)

A1

EXPERIMENTAL

Drug: Tanespimycin

Interventions

Tanespimycin DRUG

Solution, IV This is a one arm study with the dose, frequency, and duration assigned as per previous protocol (KOS-953, 17-AAG)

Also known as: BMS-722782

A1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Interventions

tanespimycin

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: July 1, 2006
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 12, 2015

Record last verified: 2015-09

Locations

US (1)