Solid Tumor MalignanciesPhase 1NCT01183364
A Dose Escalation Study of STA-9090 and Docetaxel in Patients With Solid Tumors
A Phase 1 study testing STA-9090 (ganetespib) with Docetaxel in people with Solid Tumor Malignancies, run by Synta Pharmaceuticals Corp. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies
- What is being tested?
- STA-9090 (ganetespib) with Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University School of Medicine
Atlanta, Georgia, 30322
About this study
Official title: A Phase 1, Pharmacokinetic Study of STA-9090 in Combination With Docetaxel in Subjects With Advanced Solid Tumor Malignancies
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.
- Conditions
- Solid Tumor Malignancies
- Being tested
- STA-9090 (ganetespib) with Docetaxel
- Keywords
- solid tumor malignancies, tumor, cancer, STA-9090, ganetespib, HSP90 inhibitor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA-9090 (ganetespib) with DocetaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| STA-9090 and Docetaxel | Experimental | STA-9090 (ganetespib) and Docetaxel Receives: Drug: STA-9090 (ganetespib) with Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of STA-9090 (ganetespib) and docetaxel combination
The number of adverse events will be used as a measure of safety
Measured: June 2011
Secondary outcomes (1)
Pharmacokinetics
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).
Measured: June 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synta Pharmaceuticals Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183364
- Sponsor's protocol ID
- 9090-07
- Status last verified
- Sep 2014
- First submitted
- 11 Aug 2010
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Pharmacokinetic Study of STA-9090 in Combination With Docetaxel in Subjects With Advanced Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT01183364
- Acronym / sponsor ID
- 9090-07
- Conditions
- Solid Tumor Malignancies
- Keywords
- solid tumor malignancies, tumor, cancer, STA-9090, ganetespib, HSP90 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STA-9090 and Docetaxel | Experimental | Drug: STA-9090 (ganetespib) with DocetaxelSTA-9090 (ganetespib) and Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STA-9090 (ganetespib) with DocetaxelOne 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. | Drug | STA-9090 and Docetaxel |
Primary outcome
Safety of STA-9090 (ganetespib) and docetaxel combination
Time frame: June 2011
The number of adverse events will be used as a measure of safety
1 secondary outcome
Pharmacokinetics
Time frame: June 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STA-9090 (ganetespib) with Docetaxel in people with Solid Tumor Malignancies, run by Synta Pharmaceuticals Corp. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of STA-9090 (ganetespib) and docetaxel combination (time frame: June 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.