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

Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609179
• Other study ID #: IPI-926-09
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: November 13, 2012
• Start date: March 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Infinity Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A treatment protocol that enables patients to have continued access to IPI-926.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma, Basal Cell
• Chondrosarcoma

Intervention

Drug:
• IPI-926
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.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Infinity Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No