Expired Study
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Boston, Massachusetts 02115


Purpose:

An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)


Study summary:

This is an open-label Phase 1 dose-escalation study in patients with solid tumors treated with STA-9090 (ganetespib) to evaluate for safety, tolerance and efficacy.


Criteria:

Inclusion Criteria: - Patients must be documented to be refractory or not candidates for current approved therapies. - Must have anECOG status 0-2. - Peripheral neuropathy ?2. - Must have acceptable organ and marrow function per protocol parameters. - No clinically significant ventricular arrythmias or ischemia. Exclusion Criteria: - Must not be pregnant or breastfeeding. -No chemotherapy or radiation within 3 weeks.. - No previous radiation to >25% of total bone marrow. - No previous high dose chemotherapy with autologous or allogeniec hematopoietic stem cell transplantation. - No primary brain tumors or active brain metastases. - No use of any investigational agents within 4 weeks. - No treatment with chronic immunosuppressants. - No uncontrolled, intercurrent illness.


Study is Available At:


Original ID:

9090-01


NCT ID:

NCT00688116


Secondary ID:


Study Acronym:


Brief Title:

Study of STA-9090, Administered Twice-Weekly in Patients With Solid Tumors


Official Title:

A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice-Weekly in Patients With Solid Tumors


Overall Status:

Active, not recruiting


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

25 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Synta Pharmaceuticals Corp.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

45


Enrollment Type:

Anticipated


Study Dates

Start Date:October 2007
Completion Date:November 2014
Completion Type:Anticipated
Primary Completion Date:April 2014
Primary Completion Type:Actual
Verification Date:September 2014
Last Changed Date:September 17, 2014
First Received Date:May 28, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities and evaluation of Adverse Events in relation to Study Drug.
Time Frame:Cycle 1
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:STA 9090 (ganetespib)
Description:This is a dose-escalation study. The first cohort will consist of three patients who will receive 2 mg/m2 of STA 9090 (ganetespib) during a 1-hour infusion 2 times per week (e.g., [Monday, Thursday] or [Tuesday, Friday]) for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive 4, 7, 10, 14, 19, 25, 33, 40 and 48 mg/m2 provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Further dose increments will be approximately 20% over
Arm Name:ganetespib

Study Arms

Study Arm Type:Experimental
Arm Name:ganetespib

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Synta Pharmaceuticals Corp.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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