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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01609179
First received: May 29, 2012
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Basal Cell Carcinoma
Chondrosarcoma
Drug: IPI-926

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IPI-926 Extension Protocol for Continuation of IPI-926 Treatment in Patients Experiencing Clinical Benefit While Enrolled in an IPI-926 Protocol

Resource links provided by NLM:


Further study details as provided by Infinity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Incidence of adverse events (AEs) and serious adverse events (SAEs), and laboratory test results [ Time Frame: Up to 30 days after the last patient study visit ] [ Designated as safety issue: No ]
    Monitoring of AEs, including SAEs as well as review of laboratory sample test data to assess safety and tolerability of IPI-926


Enrollment: 9
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPI-926 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.
Other Name: saridegib

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609179

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
Study Director: Tess Schmalbach, MD Infinity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01609179     History of Changes
Other Study ID Numbers: IPI-926-09
Study First Received: May 29, 2012
Last Updated: November 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Chondrosarcoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma

ClinicalTrials.gov processed this record on September 18, 2014