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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00688116

Enrollment

Registered

2008-06-02

Start date

2007-10-31

Completion date

2014-11-30

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, STA-9090, ganetespib

Brief summary

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

Detailed description

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.

Interventions

DRUGSTA 9090 (ganetespib)

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 the previous dose level, until the maximum tolerated dose (MTD) is determined.

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

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.

Design outcomes

Primary

Measure	Time frame
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.	Cycle 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026