AMLPhase 1NCT00858572
STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders
A Phase 1 study testing STA-9090 (ganetespib) in people with AML and CML, run by Synta Pharmaceuticals Corp. at 3 sites in United States.
Trial summary
The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- STA-9090 (ganetespib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2009to Feb 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
- Males and females 18 years or older
- Eligible subjects must have one of the following relapsed or refractory hematologic malignancies: AML, MDS, CML, or myeloproliferative disorders as defined in the protocol
- Must have acceptable organ function during screening as defined in the protocol
Who cannot join
- Pregnant or breast-feeding women
- Patients must meet the washout periods for prior chemotherapies and radiation
- History of stroke within 6 months of treatment
- Poor venous access for study drug administration
- Treatment with chronic immunosuppressants
- Other severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Boston, Massachusetts, 02115
Study site
New York, New York, 10065
Study site
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice Weekly in Subjects With Hematologic Malignancies
The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.
- Conditions
- AML, CML, MDS, Myeloproliferative Disorders
- Being tested
- STA-9090 (ganetespib)
- Keywords
- Synta, STA-9090, AML, CML, MDS, myeloproliferative disorder, hematologic malignancy, ganetespib
- Medical subject headings
- Myeloproliferative Disorders, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA-9090 (ganetespib)Drug
Chemotherapy agent
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Not described Receives: Drug: STA-9090 (ganetespib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies
Measured: Feb 2011
To assess preliminary evidence of anti-neoplastic activity
Measured: Feb 2011
To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion
Measured: Feb 2011
Secondary outcomes (3)
To assess changes in biomarkers following study drug administration
Measured: Feb 2011
To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters
Measured: Feb 2011
To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib)
Measured: Feb 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies 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
- 31 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
- NCT00858572
- Sponsor's protocol ID
- 9090-03
- Status last verified
- Sep 2014
- First submitted
- 6 Mar 2009
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice Weekly in Subjects With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00858572
- Acronym / sponsor ID
- 9090-03
- Conditions
- AML, CML, MDS, Myeloproliferative Disorders
- Keywords
- Synta, STA-9090, AML, CML, MDS, myeloproliferative disorder, hematologic malignancy, ganetespib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Mar 2009 (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.
The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Drug: STA-9090 (ganetespib) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females 18 years or older
- Eligible subjects must have one of the following relapsed or refractory hematologic malignancies: AML, MDS, CML, or myeloproliferative disorders as defined in the protocol
- Must have acceptable organ function during screening as defined in the protocol
Key exclusion criteria (6 listed)
- Pregnant or breast-feeding women
- Patients must meet the washout periods for prior chemotherapies and radiation
- History of stroke within 6 months of treatment
- Poor venous access for study drug administration
- Treatment with chronic immunosuppressants
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)Chemotherapy agent | Drug | Cohort |
Primary outcome
To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies
Time frame: Feb 2011
To assess preliminary evidence of anti-neoplastic activity
Time frame: Feb 2011
To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion
Time frame: Feb 2011
3 secondary outcomes
To assess changes in biomarkers following study drug administration
Time frame: Feb 2011
To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters
Time frame: Feb 2011
To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib)
Time frame: Feb 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 18 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.
3 sites 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) in people with AML and CML, run by Synta Pharmaceuticals Corp. at 3 sites 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 3 inclusion and 6 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 18 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 3 sites 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?
To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies (time frame: Feb 2011). The study lists 3 primary outcomes in all. 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 18 Sep 2014.