Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Hematologic Malignancies

Part of paid clinical trials in Denver, Colorado.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT01871675
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IPI-145 — DRUG
  • Rituximab — DRUG
  • Bendamustine — DRUG

Study Details

The goal of this study is to characterize the safety, maximum tolerated dose (MTD) and preliminary efficacy profile of IPI-145 given in combination with rituximab, or bendamustine plus rituximab, to subjects with select relapsed/refractory hematologic malignancies.

Key Dates

Start date
May 31, 2013
Status verified
Jul 2016
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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 ]

Locations (4)

FacilityCityStateZIPSite coordinators
The Colorado Blood Cancer InstituteDenverColorado80218-
Florida Cancer SpecialistsSarasotaFlorida34232-
Oklahoma UniversityOklahoma CityOklahoma73104-
Tennessee Oncology, PLLCNashvilleTennessee37203-

Find similar trials in Denver, CO

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
The Colorado Blood Cancer Institute· Denver, COFlorida Cancer Specialists· Sarasota, FLOklahoma University· Oklahoma City, OKTennessee Oncology, PLLC· Nashville, TN

Related Studies