Clinical trial NCT01609179: 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
Overall status: COMPLETED
Phase: NA
Conditions: Basal Cell Carcinoma
Chondrosarcoma
Lead sponsor: Infinity Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Voluntarily sign the informed consent form
2. 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.
3. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
4. Documented response or stable disease, as defined in the original protocol, at the time of entry to the extension study.
5. Willingness and ability to continue IPI-926 dispensation and follow-up procedures at the current investigational site.
6. Willingness and ability to comply with scheduled visits, treatment plans, and laboratory tests and other study procedures.
7. 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:

1. Discontinued IPI-926 or withdrew informed consent to participate in original Infinity-sponsored IPI-926 study.
2. Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study.

Primary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs), and laboratory test results
timeFrame: Up to 30 days after the last patient study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Infinity Pharmaceuticals, Inc.
name: Tess Schmalbach, MD
role: STUDY_DIRECTOR
References: