A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
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| ClinicalTrials.gov Identifier: NCT01310816 |
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Recruitment Status :
Completed
First Posted : March 9, 2011
Last Update Posted : December 5, 2013
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Sponsor:
Infinity Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
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Brief Summary:
IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Conventional Chondrosarcoma | Drug: IPI-926 Drug: Placebo Arm | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 105 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | February 2011 |
| Actual Primary Completion Date : | November 2013 |
| Actual Study Completion Date : | December 2013 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: IPI-926
IPI-926
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Drug: IPI-926
Oral |
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Placebo Comparator: Sugar Pill
Placebo Arm, sugar pill
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Drug: Placebo Arm
oral placebo |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Comparison of Time To Progression (TTP) [ Time Frame: estimated 6 months ]*To compare, Time To Progression (TTP) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
- Comparison of Overall Survival (OS) [ Time Frame: estimated 6 months ]To compare Overall Survival (OS) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
- Overall Response Rate (ORR) [ Time Frame: estimated 6 months ]To compare Overall Response Rate (ORR) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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).
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310816
Locations
Show 36 study locations
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
| Study Chair: | Pedro Santabarbara, MD | Infinity Pharmaceuticals, Inc. |
| Responsible Party: | Infinity Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01310816 |
| Other Study ID Numbers: |
IPI-926-04 |
| First Posted: | March 9, 2011 Key Record Dates |
| Last Update Posted: | December 5, 2013 |
| Last Verified: | December 2013 |
Keywords provided by Infinity Pharmaceuticals, Inc.:
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malignant neoplasms of the bone bone sarcoma |
Additional relevant MeSH terms:
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Chondrosarcoma Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Sarcoma |