A Dose Escalation Study of STA-9090 and Docetaxel in Patients With Solid Tumors
This study is currently recruiting participants.
Verified July 2011 by Synta Pharmaceuticals Corp.
Sponsor:
Synta Pharmaceuticals Corp.
Information provided by:
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01183364
First received: August 11, 2010
Last updated: July 8, 2011
Last verified: July 2011
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Purpose
This is an open-label, Phase 1, dose-escalation study to determine the recommended doses of STA-9090 (ganetespib) and docetaxel for the treatment of subjects with solid tumor malignancies. The safety and tolerability of the treatment will also be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumor Malignancies |
Drug: STA-9090 (ganetespib) with Docetaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Pharmacokinetic Study of STA-9090 in Combination With Docetaxel in Subjects With Advanced Solid Tumor Malignancies |
Resource links provided by NLM:
Further study details as provided by Synta Pharmaceuticals Corp.:
Primary Outcome Measures:
- Safety of STA-9090 (ganetespib) and docetaxel combination [ Time Frame: June 2011 ] [ Designated as safety issue: Yes ]The number of adverse events will be used as a measure of safety
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: June 2011 ] [ Designated as safety issue: No ]Pharmacokinetics of STA-9090 (ganetespib) and Docetaxel. This includes concentrations of these drugs in patients' blood at various protocol-specified times relative to the time of dose administration. These will be summarized by parameters including maximum concentration, total exposure and how fast the patient's body gets rid of the drug (known as Cmax, AUC, t1/2, respectively).
| Estimated Enrollment: | 27 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: STA-9090 and Docetaxel
STA-9090 (ganetespib) and Docetaxel
|
Drug: STA-9090 (ganetespib) with Docetaxel
One treatment cycle will consist of weekly treatments for 2 weeks followed by a 1-week rest period. Treatment cycles will be repeated every 3 weeks. STA-9090 will be administered on Days 1 and 8 of each cycle and docetaxel will be administered on Day 1 of each cycle. Each agent will be administered as a separate 1-hour intravenous infusion.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must have histologically confirmed metastatic or unresectable malignancy with evidence of progression
- If subject has been treated with docetaxel, must have evidence of persistent or progressive disease
- Measurable disease per RECIST
- CNS metastases are permitted if treated and radiographically and clinically stable for 4 weeks prior to first dose
- ECOG status less than or equal to 2
- Life expectancy greater than 3 months
- Adequate hematological, hepatic and renal function as defined by protocol
- Willingness and ability to comply with study requirements
- Female subjects of childbearing age must have a negative pregnancy test at study entry
- Female subjects of child bearing age and males must agree to use adequate contraception as defined in the protocol
Exclusion Criteria:
- Prior chemotherapy or investigational agents within 3 weeks or 5 times the agent's half life, whichever is shorter prior to first dose
- Radiotherapy within 2 weeks of first dose
- Surgery, radiotherapy or ablative procedure to the only area of measurable disease
- Major surgery within 4 weeks of first dose
- Poor venous access that would require an indwelling catheter for study drug administration
- History of severe allergic or hypersensitivity reactions to STA-9090 or docetaxel or their diluents or excipients
- Baseline QTc >470 msec or previous history of QT prolongation while taking other medications
- Peripheral neuropathy > Grade 1
- Ventricular ejection fraction less than or equal to 55% at baseline
- Treatment with chronic immunosuppressants. However subjects may receive steroids for stable CNS metastases
- Women who are pregnant or lactating
- Uncontrolled intercurrent illness
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183364
Contacts
| Contact: Kelly Maslin | 781-541-7150 | kmaslin@syntapharma.com |
| Contact: Amy Gauger | 781-541-7985 | agauger@syntapharma.com |
Locations
| United States, Georgia | |
| Emory University School of Medicine | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Sally Cotty 404-778-1805 amerrie@emory.edu | |
| Contact: Almelida Rene Merriewether, MPH 404-778-1802 amerrie@emory.edu | |
| Principal Investigator: Suresh Ramalingam, MD | |
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
More Information
No publications provided
| Responsible Party: | Kelly Maslin, Synta Pharmaceuticals Corp. |
| ClinicalTrials.gov Identifier: | NCT01183364 History of Changes |
| Other Study ID Numbers: | 9090-07 |
| Study First Received: | August 11, 2010 |
| Last Updated: | July 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Synta Pharmaceuticals Corp.:
|
solid tumor malignancies tumor cancer |
STA-9090 ganetespib HSP90 inhibitor |
Additional relevant MeSH terms:
|
Neoplasms Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012
