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

Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

Incidence of adverse events (AEs) and serious adverse events (SAEs), and laboratory test results


Condition

Basal Cell Carcinoma

Intervention

IPI-926

Study Arms / Comparison Groups

 IPI-926
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

9

Start Date

March 2012

Completion Date

November 2012

Primary Completion Date

October 2012

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tess Schmalbach, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01609179

Organization ID

IPI-926-09


Responsible Party

Sponsor

Study Sponsor

Infinity Pharmaceuticals, Inc.


Study Sponsor

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


Verification Date

November 2012