Emergent Initiates Phase 2 Study of TRU-016 in Combination with Bendamustine in Patients with Relapsed Chronic Lymphocytic Leukemia
“Preclinical studies have demonstrated increased anti-tumor activity for
the combination of bendamustine and TRU-016 beyond the results achieved
when either drug was administered alone,” said
The open-label, multi-center, active-controlled study is enrolling bendamustine-naïve patients with a confirmed diagnosis of relapsed CLL and who have failed up to three previous treatments. The Phase 1b portion of the study evaluated 12 patients with relapsed CLL to determine a safe and tolerable dose of TRU-016 in combination with bendamustine. The primary endpoint for the Phase 1b portion was the incidence of dose-limiting toxicities.
The Phase 2 portion of the study will evaluate the safety and efficacy
of TRU-016 in combination with bendamustine compared with bendamustine
alone in a total of approximately 100 randomized patients. TRU-016 will
be dosed over six 28-day cycles. The primary endpoint for the Phase 2
study is an overall response rate as defined by 2008
Pharmacokinetics and pharmacodynamics of TRU-016 will be studied in both phases of the study. Additional information about this Phase 1b/2 clinical study can be found on www.clinicaltrials.gov (protocol 16201).
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