IPI-926 Extension Protocol for Continuation of IPI-926 Treatment in Patients Experiencing Clinical Benefit While Enrolled in an IPI-926 Protocol
18 Years
N/A
Both
Basal Cell Carcinoma, Chondrosarcoma
Trial Information
IPI-926 Extension Protocol for Continuation of IPI-926 Treatment in Patients Experiencing Clinical Benefit While Enrolled in an IPI-926 Protocol
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.
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of adverse events (AEs) and serious adverse events (SAEs), and laboratory test results
Outcome Description:
Monitoring of AEs, including SAEs as well as review of laboratory sample test data to assess safety and tolerability of IPI-926
Outcome Time Frame:
Up to 30 days after the last patient study visit
Safety Issue:
No
Principal Investigator
Tess Schmalbach, MD
Investigator Role:
Study Director
Investigator Affiliation:
Infinity Pharmaceuticals, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
IPI-926-09
NCT ID:
NCT01609179
Start Date:
March 2012
Completion Date:
November 2012
Related Keywords:
- Basal Cell Carcinoma
- Chondrosarcoma
- Carcinoma
- Carcinoma, Basal Cell
- Chondrosarcoma
Name | Location |
|---|---|
| University of Colorado Denver | Denver, Colorado 80262 |
| Johns Hopkins | Baltimore, Maryland 21231 |
