Phase I Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects With Refractory or Relapsed Lymphoma or Multiple Myeloma
This is a Phase I, open-label, multi-center dose-escalation trial evaluating the safety and
tolerability of CUDC-907 as a single agent administered orally, once daily, to patients with
relapsed or refractory lymphoma or multiple myeloma.
Sequential dose escalation cohorts of oral CUDC-907 are planned. Subject enrollment and
dose escalation will proceed according to a standard 3+3 design. In the absence of DLT,
each subject will be treated for a minimum of 21 days of continuous daily dosing, and may
continue to receive additional treatment until disease progression has been documented or
other treatment discontinuation criteria have been met. No intrasubject dose escalation will
be allowed. An MTD expansion cohort of up to 12 evaluable subjects may also be enrolled in
order to better define the safety, tolerability and activity of the study treatment.
Safety and tolerability will be assessed by the incidence and severity of adverse events as
determined by NCI Common Terminology Criteria for Adverse Events (CTCAE v4.03).
The antitumor activity of study treatment will be assessed according standard response
criteria as appropriate for each individual subject's tumor type (e.g., Revised Response
Criteria for Malignant Lymphoma and the International Uniform Response Criteria for Multiple
Exploratory biological markers of activity will be assessed in PBMC and plasma.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oral CUDC-907 in patients with relapsed or refractory lymphoma or multiple myeloma
The highest dose level studied at which fewer than 2 out of 6 subjects (< 33%) experience a dose limiting toxicity (DLT).
21 days (1 cycle of study treatment)
Maurizio Voi, MD
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Sarah Cannon Research Institute||Nashville, Tennessee 37203|