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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00687934
Enrollment
53
Registered
2008-06-02
Start date
2007-10-31
Completion date
2011-10-31
Last updated
2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

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

Interventions

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.

Sponsors

Synta Pharmaceuticals Corp.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicitiesCycle 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026