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

NCT01609179 | Completed

• 1 other identifier: IPI-926-09
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Basal Cell Carcinoma; Chondrosarcoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

IPI-926

EXPERIMENTAL

Drug: IPI-926

Interventions

IPI-926 DRUG

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.

Also known as: saridegib

IPI-926

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Infinity Pharmaceuticals, Inc.: lead

Study Sites (2)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Chondrosarcoma

Interventions

IPI-926

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma

Study Officials

• Tess Schmalbach, MD

  Infinity Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: May 31, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

US (2)