Back to resultsIPI-926 Extension Protocol for Continuation of Treatment With IPI-926
Primary Purpose
Basal Cell Carcinoma, Chondrosarcoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IPI-926
Sponsored by
About this trial
This is an interventional treatment trial for Basal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Voluntarily sign the informed consent form
- Currently receiving IPI-926 while participating in an Infinity-sponsored IPI-926 study. Note: For blinded studies, patient's treatment assignment must be unblinded according to the instructions in the original protocol to confirm they are receiving IPI-926.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
- Documented response or stable disease, as defined in the original protocol, at the time of entry to the extension study.
- Willingness and ability to continue IPI-926 dispensation and follow-up procedures at the current investigational site.
- Willingness and ability to comply with scheduled visits, treatment plans, and laboratory tests and other study procedures.
- Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum or urine pregnancy test prior to treatment. All WCBP, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study.
Exclusion Criteria:
- Discontinued IPI-926 or withdrew informed consent to participate in original Infinity-sponsored IPI-926 study.
- Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study.
Sites / Locations
- University of Colorado Denver
- Johns Hopkins
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IPI-926
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs) and serious adverse events (SAEs), and laboratory test results
Monitoring of AEs, including SAEs as well as review of laboratory sample test data to assess safety and tolerability of IPI-926
Secondary Outcome Measures
Full Information
NCT ID
NCT01609179
First Posted
May 29, 2012
Last Updated
November 13, 2012
Sponsor
Infinity Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01609179
Brief Title
IPI-926 Extension Protocol for Continuation of Treatment With IPI-926
Official Title
IPI-926 Extension Protocol for Continuation of IPI-926 Treatment in Patients Experiencing Clinical Benefit While Enrolled in an IPI-926 Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infinity Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A treatment protocol that enables patients to have continued access to IPI-926.
Detailed Description
The extension protocol is a continuation of treatment with IPI-926, as administered to each individual patient during participation in their original IPI-926 protocol.
Patients who are completing their participation in the original IPI-926 protocol in which they enrolled, as defined in the original protocol, and, have stable disease or confirmed complete or partial response as defined by the original protocol may continue to receive treatment with IPI-926 in the extension protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Chondrosarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPI-926
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IPI-926
Other Intervention Name(s)
saridegib
Intervention Description
IPI-926 is administered orally as a capsule formulation, as a fixed dose in mg/day. Patients will be administered the same dose with same cycle length of IPI-926 and combination therapy that they were receiving in the original protocol at the time of transition into the extension study. The following are potential once-daily doses that patients are receiving in original protocols: 60 mg, 90 mg, 100 mg, 110 mg, 130 mg, or 160 mg.
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs) and serious adverse events (SAEs), and laboratory test results
Description
Monitoring of AEs, including SAEs as well as review of laboratory sample test data to assess safety and tolerability of IPI-926
Time Frame
Up to 30 days after the last patient study visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntarily sign the informed consent form
Currently receiving IPI-926 while participating in an Infinity-sponsored IPI-926 study. Note: For blinded studies, patient's treatment assignment must be unblinded according to the instructions in the original protocol to confirm they are receiving IPI-926.
Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
Documented response or stable disease, as defined in the original protocol, at the time of entry to the extension study.
Willingness and ability to continue IPI-926 dispensation and follow-up procedures at the current investigational site.
Willingness and ability to comply with scheduled visits, treatment plans, and laboratory tests and other study procedures.
Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum or urine pregnancy test prior to treatment. All WCBP, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study.
Exclusion Criteria:
Discontinued IPI-926 or withdrew informed consent to participate in original Infinity-sponsored IPI-926 study.
Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tess Schmalbach, MD
Organizational Affiliation
Infinity Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
IPI-926 Extension Protocol for Continuation of Treatment With IPI-926
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