Overview

This trial is active, not recruiting.

Condition cd20+ follicular lymphoma
Treatments ipi-145 (duvelisib), rituximab, obinutuzumab
Phase phase 1/phase 2
Targets CD20, PI3K
Sponsor Infinity Pharmaceuticals, Inc.
Start date December 2014
End date July 2017
Trial size 120 participants
Trial identifier NCT02391545, IPI-145-19

Summary

A Two-arm, Phase 1b/2 Study of IPI-145 Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
IPI-145 is administered orally and supplied as 5 mg and 25 mg formulated capsules. IPI-145 will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
ipi-145 (duvelisib)
PI3K Inhibitor
rituximab Rituxan/MabThera®
(Experimental)
IPI-145 is administered orally and supplied as 5 mg and 25 mg formulated capsules.IPI-145 will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
ipi-145 (duvelisib)
PI3K Inhibitor
obinutuzumab GAZYVA/GAZYVARO™

Primary Outcomes

Measure
Dose limiting toxicities (DLTs) - Part 1
time frame: 28 days from first dose of study treatment
Complete Response Rate (CRR)- Part 2
time frame: Up to 2 years from the first dose of study treatment

Secondary Outcomes

Measure
Safety: Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values
time frame: Up to 30 days after the last dose of study treatment
Overall Response Rate (ORR)
time frame: Up to 2 years from the first dose of study treatment
Duration of response (DOR)
time frame: Up to 2 years from the first dose of study treatment
Overall survival (OS)
time frame: Up to 2 years from the first dose of study treatment
Pharmacokinetic (PK): Plasma concentrations of IPI-145 and IPI-656 (metabolite)
time frame: Every 4 weeks for 16 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of CD20+, follicular lymphoma that has not been treated - CD20-immunophenotyping of tumor to document B-cell follicular lymphoma - Stage II disease with bulky disease (≥ 7cm lesion), Stage III, or Stage IV disease - Disease that requires treatment based on the Investigator's opinion (e.g., meets GELF criteria) - At least one measurable lesion that is > 1.5 cm in at least one dimension - Eastern Cooperative Oncology Group (ECOG) performance status <=2 (corresponds to Karnofsky Performance Status [KPS] >=60%) Exclusion Criteria: - Received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy. - Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B follicular lymphoma - Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs - Prior allogeneic hematopoietic stem cell transplant - Prior, current or chronic hepatitis B or hepatitis C infection - Human immunodeficiency virus (HIV) infection or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection

Additional Information

Official title A Two-arm, Phase 1b/2 Study of Duvelisib Administered in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
Description This is a two-arm, open-label, Phase 1b/2 trial designed to evaluate the safety and efficacy of IPI-145 in combination with rituximab and IPI-145 in combination with obinutuzumab in subjects with previously untreated CD20+ FL. The study will be conducted in two parts, a Safety Lead-in (Part 1) followed by a randomized, 2-Stage Design in Part 2. Each treatment arm will be assessed independently for dose limiting toxicity (DLT) within Part 1.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Infinity Pharmaceuticals, Inc..
Location data was received from the National Cancer Institute and was last updated in August 2016.