Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT01871675|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : July 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Chronic Lymphocytic Leukemia Non-Hodgkin Lymphoma T-cell Lymphoma||Drug: IPI-145 Drug: Rituximab Drug: Bendamustine||Phase 1|
This trial consists of two parallel arms. For each treatment arm, a 3+3 dose escalation design will be applied in 3-6 subject cohorts until the maximum tolerated dose of IPI-145 when given with rituximab (Arm 1) or in combination with rituximab and bendamustine (Arm 2) is determined. Treatment arm selection will be chosen by the investigator and will depend on the agents previously administered to the subject. Once the MTD has been determined, the arms will move on to a dose expansion phase. During the dose expansion phase, each treatment arm will enroll to population specific cohorts to assess efficacy. All subjects must have had at least one prior anticancer treatment. The dose expansion cohorts are:
Arm 1: Cohort A - CLL: Cohort B - CD20+ NHL
Arm 2: Cohort A - CLL: Cohort B - CD20+ NHL
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Phase Ib Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Select Subjects With Lymphoma or Chronic Lymphocytic Leukemia|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Arm 1: IPI-145 plus Rituximab
IPI-145 will be administered orally, twice daily, in 28-day (4-week) cycles, on a continuous basis at the maximum tolerated dose of 25 mg twice-daily (BID), as determined in the dose escalation phase. Twelve (12) cycles of IPI-145 will be administered. Patients who benefit from treatment may continue on study for additional cycles until toxicity or progressive disease.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Day 1 once weekly during a 28 day cycle; 2 cycles of rituximab will be administered.
Other Name: Duvelisib
Other Name: Rituxan
Experimental: Arm 2: IPI-145 plus Rituximab/Bendamustine
IPI-145 will be administered orally, twice daily, in 28 day cycles, on a continuous basis, until disease progression, unacceptable toxicity or patient refusal. The maximum tolerated dose of IPI-145 will be 25 mg twice-daily (BID) as determined in the dose escalation phase. Twelve (12) cycles of IPI-145 will be administered. Patients who benefit from treatment may continue on study for additional cycles until toxicity or progressive disease.
Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Day 1 once weekly of each 28 day cycle. A maximum of 6 cycles of rituximab will be given. Bendamustine 90 mg/m2 IV will be administered on Days 1 and 2, of each 28 day cycle. Rituximab should be administered prior to bendamustine.
Other Name: Duvelisib
Other Name: Rituxan
Other Name: Treanda
- The number of adverse events, serious adverse events, and dose limiting toxicities as a measure of safety and tolerability [ Time Frame: up to 12 months ]The maximum tolerated dose of IPI-145 defined as the optimal dose at which ≤1 of 6 patients experiences a DLT assessed by NCI CTCAE v4.0.
- Antitumor activity [ Time Frame: Up to 5 years ]Preliminary information on antitumor activity of IPI-145 when combined with rituximab, or bendamustine/rituximab as measured by objective response rate, progression free survival and overall survival data
- PK of IPI-145 and its metabolites [ Time Frame: Day 1 ]Pharmacokinetics (PK) of IPI-145 and its metabolites when combined with rituximab or bendamustine/rituximab will be obtained by evaluating maximum concentration and area under the curve pre-dose and up to 6 hours post-dose.
- PDx of IPI-145 [ Time Frame: Up to 12 months ]Pharmacodynamics (PDx) of IPI-145 when combined with rituximab or bendamustine/rituximab will be evaluated by assessing chemokines and cytokines.
- Molecular predictors of IPI-145 [ Time Frame: Up to 12 months ]Develop molecular predictors of response when IPI-145 is combined with rituximab or bendamustine/rituximab by assessing protein expression and potential mutations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871675
|United States, Colorado|
|The Colorado Blood Cancer Institute|
|Denver, Colorado, United States, 80218|
|United States, Florida|
|Florida Cancer Specialists|
|Sarasota, Florida, United States, 34232|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Tennessee|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37203|
|Study Chair:||Ian Flinn, M.D.||SCRI|