A Phase 2 Study of IPI-145 in Subjects With Refractory Indolent Non-Hodgkin Lymphoma
18 Years
N/A
Both
Indolent Non-Hodgkin Lymphoma
Trial Information
A Phase 2 Study of IPI-145 in Subjects With Refractory Indolent Non-Hodgkin Lymphoma
This is an open-label, single arm safety and efficacy study of IPI-145 administered orally
to subjects who have been diagnosed with iNHL (FL, MZL, or SLL) whose disease is refractory
to rituximab and chemotherapy in combination or RIT.
Approximately 120 subjects will receive 25 mg IPI-145 BID over the course of 28-day
treatment cycles for up to 12 cycles.
After completing 12 treatment cycles of IPI-145, subjects may continue to receive additional
cycles of IPI-145 for up to a total of 2 years of treatment. However, to receive additional
cycles of IPI-145 beyond 12 cycles, subjects must have evidence of response (CR or PR)
according to the IWG criteria1 by the end of Cycle 12.
Inclusion Criteria:
- Subjects who have been diagnosed with indolent NHL that has progressed.
- Subjects must have exhibited no response or progression within 6 months after the
last dose of a chemotherapy induction regimen or RIT.
- Subjects must have rituximab-refractory disease.
- Measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension
by CT.
- Adequate renal and hepatic function.
Exclusion Criteria:
- Candidate for potentially curative therapies in the opinion of the investigator.
- Previous treatment with a PI3K inhibitor within 30 days of starting IPI-145 therapy.
- Prior history of allogeneic hematopoietic stem cell transplant (HSCT).
- Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents
within 3 weeks before first dose of study drug.
- Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype
of lymphoma.
- Symptomatic central nervous system (CNS) NHL.
- Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of
study treatment.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate (ORR) in all subjects during treatment with IPI-145 based on standard response.
Outcome Time Frame:
Every 8-16 weeks while on treatment with IPI-145; an expected average on-treatment duration of response follow-up of 20 months
Safety Issue:
No
Principal Investigator
Patrick Kelly, MD
Investigator Role:
Study Director
Investigator Affiliation:
Infinity Pharmaceuticals, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
IPI-145-06
NCT ID:
NCT01882803
Start Date:
May 2013
Completion Date:
November 2017
Related Keywords:
- Indolent Non-Hodgkin Lymphoma
- PI3K Inhibitor
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Nashville, Tennessee 37203-1632 |
