Dedifferentiated LiposarcomaPhase 2NCT00969917
Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
A Phase 2 study testing IPI-504 in people with Dedifferentiated Liposarcoma, run by Infinity Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary objective of the study is to determine the safety profile and overall response rate of IPI 504 in patients with advanced dedifferentiated liposarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dedifferentiated Liposarcoma
- What is being tested?
- IPI-504
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2010
- Phase
- Phase 2
- 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
- At least 18 years of age at the time of signing informed consent.
- Histologic diagnosis of dedifferentiated liposarcoma.
- Available archival pathology specimen or tissue sample from a new biopsy for confirmation of diagnosis by central pathology reading.
- At least one prior chemotherapy regimen for dedifferentiated liposarcoma.
- No more than 2 prior chemotherapy regimens for dedifferentiated liposarcoma. Note: Any number of non-chemotherapy regimens is permitted.
- Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST (version 1.1) with at least one measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
- Life expectancy ≥6 months.
Who cannot join
- Prior treatment with any heat shock protein 90 (Hsp90) inhibitor.
- Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease
- Patients with prior hepatic resections or hepatic-directed therapy
- Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to dosing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase 2, Open-Label Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
The primary objective of the study is to determine the safety profile and overall response rate of IPI 504 in patients with advanced dedifferentiated liposarcoma.
- Conditions
- Dedifferentiated Liposarcoma
- Being tested
- IPI-504
- Medical subject headings
- Liposarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-504Drug
IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment
| Study group | Role | What they receive |
|---|---|---|
| IPI-504 | Experimental | IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment Receives: Drug: IPI-504 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma.
Measured: Every 6 weeks
Secondary outcomes (1)
To determine the clinical benefit rate and duration of overall response
Measured: Every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010
Why it stopped: Company decision not to start the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dedifferentiated LiposarcomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infinity Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969917
- Sponsor's protocol ID
- IPI-504-09
- Status last verified
- Apr 2015
- First submitted
- 1 Sep 2009
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
- ClinicalTrials.gov ID
- NCT00969917
- Acronym / sponsor ID
- IPI-504-09
- Conditions
- Dedifferentiated Liposarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision not to start the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Infinity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010
- First posted
- 2 Sep 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 primary objective of the study is to determine the safety profile and overall response rate of IPI 504 in patients with advanced dedifferentiated liposarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPI-504 | Experimental | Drug: IPI-504IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age at the time of signing informed consent.
- Histologic diagnosis of dedifferentiated liposarcoma.
- Available archival pathology specimen or tissue sample from a new biopsy for confirmation of diagnosis by central pathology reading.
- At least one prior chemotherapy regimen for dedifferentiated liposarcoma.
- No more than 2 prior chemotherapy regimens for dedifferentiated liposarcoma. Note: Any number of non-chemotherapy regimens is permitted.
Key exclusion criteria (4 listed)
- Prior treatment with any heat shock protein 90 (Hsp90) inhibitor.
- Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease
- Patients with prior hepatic resections or hepatic-directed therapy
- Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to dosing.
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 |
|---|---|---|
| IPI-504IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment | Drug | IPI-504 |
Primary outcome
To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma.
Time frame: Every 6 weeks
1 secondary outcome
To determine the clinical benefit rate and duration of overall response
Time frame: Every 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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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 2 study testing IPI-504 in people with Dedifferentiated Liposarcoma, run by Infinity Pharmaceuticals, Inc. 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 8 inclusion and 4 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: withdrawn, as of the sponsor's last update on 14 Apr 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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 determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma. (time frame: Every 6 weeks). 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 14 Apr 2015.