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

NCT00687934 | Completed Phase 1

• 1 other identifier: 9090-02
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Solid Tumors

Keywords

metastatic cancer; solid tumor; histologically or cytologically confirmed non-hematological; malignancy that is metastatic or unresectable for which no; standard therapy exists; STA-9090; ganetespib

Outcome Measures

Primary Outcomes (1)

• The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities

  Cycle 1

Study Arms (1)

Ganetespib

EXPERIMENTAL

Ganetespib once weekly infusion, dose escalation study, with treatment until progression

Drug: STA-9090

Interventions

STA-9090 DRUG

This is a dose-escalation study. The first cohort will consist of three patients who will receive STA 9090 (ganetespib)during a 1-hour infusion once per week for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive higher amounts of STA-9090 (gantespib) provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Dose escalation will continue until the maximum tolerated dose (MTD) is determined.

Ganetespib

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be documented to be refractory or not candidates for current approved therapies.
• Must have an ECOG status 0-2.
• Peripheral neuropathy \< or = 2.
• Must have acceptable organ and marrow function per protocol parameters.
• No clinically significant ventricular arrythmias or ischemia.

You may not qualify if:

• Must not be pregnant or breastfeeding.
• Chemotherapy or radiation within 3 weeks.
• Previous radiation to \>25% of total bone marrow.
• Previous high dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation.
• Primary brain tumors or active brain metastases.
• Use of any investigational agents within 4 weeks.
• Treatment with chronic immunosuppressants.
• Uncontrolled, intercurrent illness.

Sponsors & Collaborators

• Synta Pharmaceuticals Corp.: lead

Study Sites (2)

Premiere Oncology

Santa Monica, California, 90404-2111, United States

Location

US Oncology Dayton Oncology and Hematology, P.A

Kettering, Ohio, 45409, United States

Location

Related Publications (1)

• Goldman JW, Raju RN, Gordon GA, El-Hariry I, Teofilivici F, Vukovic VM, Bradley R, Karol MD, Chen Y, Guo W, Inoue T, Rosen LS. A first in human, safety, pharmacokinetics, and clinical activity phase I study of once weekly administration of the Hsp90 inhibitor ganetespib (STA-9090) in patients with solid malignancies. BMC Cancer. 2013 Mar 25;13:152. doi: 10.1186/1471-2407-13-152.

  PMID: 23530663 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

STA 9090

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: October 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

US (2)