Conventional ChondrosarcomaPhase 2NCT01310816
A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
A Phase 2 study testing IPI-926 in people with Conventional Chondrosarcoma, run by Infinity Pharmaceuticals, Inc. at 36 sites in 13 countries.
Trial summary
IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conventional Chondrosarcoma
- What is being tested?
- IPI-926
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 36 sitesin 13 countries
- Study dates
- Feb 2011to Dec 2013
- 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.
- Pathologically diagnosed conventional chondrosarcoma. Patients must have tumor sample(s) available or provide tumor samples from a new biopsy
- Metastasis to at least 1 location or locally advanced disease that is deemed unresectable by a surgeon
- At least 1 radiologically measurable target lesion per RECIST 1.1.
- Patients must have documented radiographic progression of disease within the 6-month period prior to screening. (MRI or CT Scan)
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
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- Life expectancy of at least 3 months
- All women of child-bearing potential (WCBP), all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study and for 30 days after the last dose of study drug.
- Ability to adhere to the study visit schedule and all protocol requirements.
- Voluntarily signed an informed consent form.
Who cannot join
- Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer.
- Systemic anti-cancer therapy within 21 days prior to the first dose of study drug, or radiotherapy within 14 days prior to the first dose of study drug.
- Prior treatment with a Hedgehog pathway inhibitor
- Medically significant surgical procedures or significant traumatic injury within 28 days before Day 1.
- Inadequate hematologic function defined by:
- Hemoglobin <8.0 g/dL (80 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
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- Inadequate hepatic function defined by:
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN).
- Total bilirubin >1.5 x ULN (with the exception of patients with Gilbert's disease).
- Cirrhotic liver disease, ongoing alcohol abuse, or known chronic active or acute hepatitis.
- Inadequate renal function defined by serum creatinine >1.5 x ULN
- Patients with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
- Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
- Significant co-morbid condition or disease, which in the judgment of the Investigator, would place the patient at undue risk or interfere with the study. Examples include, but are not limited to sepsis and recent significant traumatic injury.
- Known human immunodeficiency virus (HIV) positivity.
- Known hypersensitivity to IPI-926, or any of the excipients in IPI-926 or placebo capsules.
- Pregnant or lactating women.
- Current administration of the medications or foods which are known to be moderate or strong inhibitors of CYP3A4 activity
Trial locations and contacts
36 sites in 13 countries.
36 sites in 13 countries
United States15 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado Cancer Center
Aurora, Colorado, 80045
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
MD Anderson Cancer Center
Houston, Texas, 77030
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Columbia University Medical Center
New York, New York, 10032
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19106
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Sarcoma Oncology Center
Santa Monica, California, 90403
(TGen) Translational Genomics Research Institute
Scottsdale, Arizona, 85258
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University in St. Louis
St Louis, Missouri, 63110
France3 sites
Centre Léon Bérard, Service d'Oncologie Médicale
Lyon, Auvergne-Rhône-Alpes, 69373
Centre René Gauducheau
Saint-Herblain, Pays de la Loire Region, 44805
Institut de Cancérologie Gustave Roussy
Villejuif, Île-de-France Region, 94805
Germany3 sites
Helios Klinikum Bad Saarow
Bad Saarow, Brandenburg, 15526
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, 68167
United Kingdom3 sites
Royal Orthopaedic Hospital
Birmingham, England, B312AP
University College Hospital
London, England, NW1 2PQ
Newcastle General Hospital
Newcastle upon Tyne, England, NE7 7DN
Australia2 sites
Sydney Cancer Centre
Camperdown, New South Wales, 2050
Monash Medical Centre
East Bentleigh, Victoria, 3165
Italy2 sites
IRCCS Istituto Ortopedico Rizzoli
Bologna, Bologna, 40136
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Milano, 20133
Russia2 sites
SI Russian Oncological Research Center
Moscow, Moscow, 115478
Moscow n.a. P.A Herzen Oncology Research Institute of Rosmedtechnologies
Moscow, Moscow, 125284
Netherlands1 site
Leids Unversitair Medisch Centrum
Leiden, South Holland, 2333 ZA
Poland1 site
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie w Warszawie
Warsaw, Masovian Voivodeship, 02-781
About this study
Official title: A Phase 2, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of IPI-926 in Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.
Read the detailed description
Study IPI-926-04 is a Phase 2, double-blind, placebo-controlled, multicenter, trial evaluating the safety and efficacy of IPI-926 in patients with metastatic or locally advanced (unresectable) chondrosarcoma. The study includes an optional cross-over to open-label IPI-926 for patients randomly assigned to placebo who experience documented disease progression.
- Conditions
- Conventional Chondrosarcoma
- Being tested
- IPI-926, Placebo Arm
- Keywords
- malignant neoplasms of the bone, bone sarcoma
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-926Drug
Oral
Placebo ArmDrug
oral placebo
| Study group | Role | What they receive |
|---|---|---|
| IPI-926 | Active comparator | IPI-926 Receives: Drug: IPI-926 |
| Sugar Pill | Placebo comparator | Placebo Arm, sugar pill Receives: Drug: Placebo Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
- To compare progression-free survival (PFS) in patients with metastatic or locally advanced (unresectable) chondrosarcoma administered IPI-926 or placebo.
- Number of Incidence of reported adverse events and abnormal laboratory test results. To evaluate the safety of IPI-926 or placebo in patients with metastatic or locally advanced (unresectable) chondrosarcoma
Measured: estimated 6 months
Secondary outcomes (3)
Comparison of Time To Progression (TTP)
*To compare, Time To Progression (TTP) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Measured: estimated 6 months
Comparison of Overall Survival (OS)
To compare Overall Survival (OS) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Measured: estimated 6 months
Overall Response Rate (ORR)
To compare Overall Response Rate (ORR) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Measured: estimated 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conventional ChondrosarcomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infinity Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Santabarbara, MD, Study chair, Infinity Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310816
- Sponsor's protocol ID
- IPI-926-04
- Status last verified
- Dec 2013
- First submitted
- 3 Mar 2011
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of IPI-926 in Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
- ClinicalTrials.gov ID
- NCT01310816
- Acronym / sponsor ID
- IPI-926-04
- Conditions
- Conventional Chondrosarcoma
- Keywords
- malignant neoplasms of the bone, bone sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Infinity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Mar 2011 (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.
IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.
Detailed description
Study IPI-926-04 is a Phase 2, double-blind, placebo-controlled, multicenter, trial evaluating the safety and efficacy of IPI-926 in patients with metastatic or locally advanced (unresectable) chondrosarcoma. The study includes an optional cross-over to open-label IPI-926 for patients randomly assigned to placebo who experience documented disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPI-926 | Active comparator | Drug: IPI-926IPI-926 |
| Sugar Pill | Placebo comparator | Drug: Placebo ArmPlacebo Arm, sugar pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years of age at the time of signing informed consent.
- Pathologically diagnosed conventional chondrosarcoma. Patients must have tumor sample(s) available or provide tumor samples from a new biopsy
- Metastasis to at least 1 location or locally advanced disease that is deemed unresectable by a surgeon
- At least 1 radiologically measurable target lesion per RECIST 1.1.
- Patients must have documented radiographic progression of disease within the 6-month period prior to screening. (MRI or CT Scan)
Key exclusion criteria (18 listed)
- Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer.
- Systemic anti-cancer therapy within 21 days prior to the first dose of study drug, or radiotherapy within 14 days prior to the first dose of study drug.
- Prior treatment with a Hedgehog pathway inhibitor
- Medically significant surgical procedures or significant traumatic injury within 28 days before Day 1.
- Inadequate hematologic function defined by:
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-926Oral | Drug | IPI-926 |
| Placebo Armoral placebo | Drug | Sugar Pill |
Primary outcome
Progression Free Survival (PFS)
Time frame: estimated 6 months
* To compare progression-free survival (PFS) in patients with metastatic or locally advanced (unresectable) chondrosarcoma administered IPI-926 or placebo. * Number of Incidence of reported adverse events and abnormal laboratory test results. To evaluate the safety of IPI-926 or placebo in patients with metastatic or locally advanced (unresectable) chondrosarcoma
3 secondary outcomes
Comparison of Time To Progression (TTP)
Time frame: estimated 6 months
Comparison of Overall Survival (OS)
Time frame: estimated 6 months
Overall Response Rate (ORR)
Time frame: estimated 6 months
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 5 Dec 2013.
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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.
Pedro Santabarbara, MD study chair
Infinity Pharmaceuticals, Inc.
36 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPI-926 in people with Conventional Chondrosarcoma, run by Infinity Pharmaceuticals, Inc. at 36 sites in 13 countries.
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 18 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 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, France, Germany, United Kingdom, Australia and 8 more countries. 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. Some participants in this study may receive a placebo. 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 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?
Progression Free Survival (PFS) (time frame: estimated 6 months). 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 5 Dec 2013.