IPI-926 Extension Protocol for Continuation of Treatment With IPI-926

Study Overview
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Brief Summary
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A treatment protocol that enables patients to have continued access to IPI-926.

Detailed Description
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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.

Official Title
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IPI-926 Extension Protocol for Continuation of IPI-926 Treatment in Patients Experiencing Clinical Benefit While Enrolled in an IPI-926 Protocol

Conditions
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Basal Cell Carcinoma, Chondrosarcoma

Intervention / Treatment
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* Drug: IPI-926


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPI-926<br> | Drug: IPI-926<br>* 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.<br>* Other names: saridegib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 30 days after the last patient study visit |