Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Phase 3 Study of IPI-145 Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Infinity Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02004522
First received: November 13, 2013
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

A Phase 3 clinical trial to examine the efficacy of IPI-145 monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Drug: IPI-145
Drug: Ofatumumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Study of IPI-145 Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (DUO)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: Until disease progression or unacceptable toxicity assessed up to 3 years ] [ Designated as safety issue: No ]
  • Hematologic improvements [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Every 6 months for up to 3 years after first dose ] [ Designated as safety issue: No ]
  • Lymph node response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Lymph node response defined as greater than or equal to 50% decrease in the SPD of target lymph nodes

  • Duration of Response (DOR) [ Time Frame: Time from the first documentation of response to first documentation of progressive disease or death due to any cause ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 30 days plus 7 days from last dose ] [ Designated as safety issue: Yes ]
    Treatment- emergent adverse events (TEAEs) and changes in safety laboratory values

  • Pharmacokinetics (PK) [ Time Frame: Cycle 2, Cycle 3, and Cycle 7 ] [ Designated as safety issue: No ]
    Evaluate the PK of IPI-145 and, if applicable, its metabolite(s)


Estimated Enrollment: 300
Study Start Date: November 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPI-145
IPI-145 is administered orally and supplied as 5 mg and 25 mg formulated capsules
Drug: IPI-145
Other Name: PI3K Inhibitor
Active Comparator: Ofatumumab
Ofatumumab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg/5mL and 1000 mg/50 mL
Drug: Ofatumumab
Other Name: Arzerra

Detailed Description:

This is an open-label, two- arm, randomized phase 3, superiority trial designed to evaluate the efficacy and safety of IPI-145 compared to ofatumumab administered to patients who have been diagnosed with CLL/SLL whose disease is relapsed or refractory.

Approximately 150 subjects will receive a starting dose of 25 mg IPI-145 BID initially over the course of 21-day treatment cycle followed by 28-day treatment cycles for up to 18 cycles.

Approximately 150 subjects will receive a starting dose of 300 mg ofatumumab on Day 1 followed by seven weekly doses of 2000 mg. Thereafter, subjects will receive 2000 mg ofatumumab once every month for four months. Administration of ofatumumab will not exceed the 12 doses (within 7 cycles).

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of CLL or SLL that meets at least 1 of the IWCLL 2008 criteria for requiring treatment
  • Must have received at least one prior therapy for CLL/SLL
  • Measurable nodal disease by CT
  • ECOG performance status of 0-2
  • Considered not appropriate for treatment with purine-based analogue regimen

Exclusion Criteria:

  • History of Richter's transformation or prolymphocytic leukemia
  • Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP)
  • Refractory to ofatumumab (progression or relapse <12 months of receiving ofatumumab therapy or <24 months of receiving an ofatumumab- containing regimen)
  • Prior allogeneic transplant
  • Known central nervous system lymphoma or leukemia
  • Previous treatment with a PI3K inhibitor or BTK inhibitor
  • Tyrosine kinase inhibitor within 7 days of randomization
  • Ongoing systemic bacterial, fungal, or viral infections
  • History of tuberculosis within preceding two years
  • Prior, current, or chronic hepatitis B or hepatitis C infection
  • History of stroke, unstable angina, myocardial infarction or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
  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: NCT02004522

Contacts
Contact: Fiona Patterson 617-453-1180 fiona.patterson@infi.com

  Show 89 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: NCT02004522     History of Changes
Other Study ID Numbers: IPI-145-07
Study First Received: November 13, 2013
Last Updated: October 20, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Austria: Agency for Health and Food Safety
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Italy: The Italian Medicines Agency
New Zealand: Medsafe
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Infinity Pharmaceuticals, Inc.:
Phase 3
CLL/SLL
Pi3K

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014