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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 August 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: August 28, 2014
Last verified: August 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 rituximab and to either chemotherapy 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:
  • Overall 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 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment- emergent adverse events (TEAEs) and changes in safety laboratory values [ 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 ]
  • PK Plasma concentrations of IPI-145 and its metabolite(s) [ Time Frame: Every 4 weeks for 12 weeks ] [ Designated as safety issue: No ]
  • Time to response (TTR) [ Time Frame: First dose to first documentation of complete or partial response ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (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 to either chemotherapy or RIT.

Approximately 120 subjects will receive 25 mg IPI-145 BID over the course of 28-day treatment cycles for up to 13 cycles.

After completing 13 treatment cycles of IPI-145, subjects may continue to receive additional cycles of IPI-145 for an additional year for a total of 2 years of treatment. However, to receive additional cycles of IPI-145 beyond 13 cycles, subjects must have evidence of response (CR or PR) according to the IWG criteria1 by the end of Cycle 13.

  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 lack of CR or PR or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT.
  • Subjects must have rituximab-refractory disease, defined as lack of CR or PR or PD within 6 months of last dose.
  • Measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension by CT, PET/CT or MRI.
  • Adequate renal and hepatic function.

Exclusion Criteria:

  • Candidate for potentially curative therapies in the opinion of the investigator.
  • Previous treatment with a PI3K inhibitor or BTK inhibitor.
  • Prior history of allogeneic hematopoietic stem cell transplant (HSCT).
  • Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 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.
  • Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis C virus antibodies (HCV Ab) or hepatitis B surface antigen (HBsAg) or hepatitis B core antibodies (HBcAb)
  • History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug
  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: Ruth Adams 617-453-1000 info@infi.com

  Show 35 Study Locations
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: August 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Infinity Pharmaceuticals, Inc.:
PI3K Inhibitor

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

ClinicalTrials.gov processed this record on September 16, 2014