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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01609179
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : November 14, 2012
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Chondrosarcoma Drug: IPI-926 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    Monitoring of AEs, including SAEs as well as review of laboratory sample test data to assess safety and tolerability of IPI-926

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01609179

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.
Study Director: Tess Schmalbach, MD Infinity Pharmaceuticals, Inc.

Responsible Party: Infinity Pharmaceuticals, Inc. Identifier: NCT01609179     History of Changes
Other Study ID Numbers: IPI-926-09
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Veratrum Alkaloids
Antihypertensive Agents