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

NCT ID: NCT00779428

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2013-07-31

Brief Summary

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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

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Conditions

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Advanced Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A1

Group Type EXPERIMENTAL

Tanespimycin

Intervention Type DRUG

Solution, IV

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

Interventions

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Tanespimycin

Solution, IV

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

Intervention Type DRUG

Other Intervention Names

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BMS-722782

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA200-002

Identifier Type: -

Identifier Source: org_study_id

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