A Phase 2 Study of IPI-145 in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Infinity Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01882803
First received: May 31, 2013
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

Phase 2 clinical trial to evaluate the safety and efficacy of IPI-145 as a monotherapy in subjects with iNHL (FL, MZL, or SLL) that is refractory to a rituximab containing chemotherapy regimen or RIT.


Condition Intervention Phase
Indolent Non-Hodgkin Lymphoma
Drug: IPI-145
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of IPI-145 in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)

Resource links provided by NLM:


Further study details as provided by Infinity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Objective response rate (ORR) in all subjects during treatment with IPI-145 based on standard response. [ 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of drug-related (at least possibly) adverse events; Number of serious adverse events [ Time Frame: Every 2-8 weeks; up to 30 days after the last dose of IPI-145 ] [ Designated as safety issue: Yes ]
  • Duration of Response [ Time Frame: Every 8-16 weeks; for an average duration of response follow-up of 24 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Every 8-16 weeks; for an average response / progression follow-up of 24 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 16 weeks; for an average survival follow-up of 24 months ] [ Designated as safety issue: No ]
  • Plasma concentrations of IPI-145 and its metabolite(s) [ Time Frame: Every 4 weeks for 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: IPI-145
    PI3K Inhibitor
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882803

Contacts
Contact: Karen Bracken 704-875-3677 karen.bracken@infi.com

Locations
United States, Alabama
Recruiting
Mobile, Alabama, United States
United States, Colorado
Recruiting
Denver, Colorado, United States
United States, Florida
Recruiting
Fort Myers, Florida, United States
Recruiting
Pensacola, Florida, United States
Recruiting
St. Petersburg, Florida, United States
Recruiting
Tallahassee, Florida, United States
United States, Georgia
Recruiting
Thomasville, Georgia, United States
United States, Kentucky
Recruiting
Louisville, Kentucky, United States
United States, Maryland
Recruiting
Baltimore, Maryland, United States
United States, Missouri
Recruiting
St. Louis, Missouri, United States
United States, Nebraska
Recruiting
Omaha, Nebraska, United States
United States, New Jersey
Recruiting
Morristown, New Jersey, United States
United States, Ohio
Recruiting
Cincinnati, Ohio, United States
United States, Oklahoma
Recruiting
Lawton, Oklahoma, United States
Recruiting
Oklahoma City, Oklahoma, United States
United States, South Dakota
Recruiting
Watertown, South Dakota, United States
United States, Tennessee
Recruiting
Chattanooga, Tennessee, United States
Recruiting
Nashville, Tennessee, United States
United States, Virginia
Recruiting
Lynchburg, Virginia, United States
United Kingdom
Recruiting
London, United Kingdom
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
Study Director: Patrick Kelly, MD Infinity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01882803     History of Changes
Other Study ID Numbers: IPI-145-06
Study First Received: May 31, 2013
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Infinity Pharmaceuticals, Inc.:
PI3K Inhibitor

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014