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CompletedNCT01609179Updated Nov 14, 2012

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

An interventional study of IPI-926 in Basal Cell Carcinoma and Chondrosarcoma, sponsored by Infinity Pharmaceuticals, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-14.

Sponsored by Infinity Pharmaceuticals, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Basal Cell Carcinoma
  • Chondrosarcoma
03

In context

Carcinoma, Basal Cell

364 studies on the registry are indexed under Carcinoma, Basal Cell; 66 are open to participants now.

This study's enrollment of 9 is below the median of 41 across 258 interventional studies indexed under Carcinoma, Basal Cell.

Browse Carcinoma, Basal Cell studies →

Lead sponsor

Infinity Pharmaceuticals, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    IPI-926

    Drug: IPI-926

Interventions

  • DrugIPI-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.

    Also known as: saridegib

06

What researchers measure

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

    Time frame: Up to 30 days after the last patient study visit

07

Study locations

2 sites
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
  • Johns Hopkins
    Baltimore, Maryland 21205, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01609179
Lead sponsor
Infinity Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
May 31, 2012
Start date
Mar 2012
Primary completion
Oct 2012
Completion
Nov 2012
Last update
Nov 14, 2012

Study contacts

Tess Schmalbach, MD
study director · Infinity Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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