Lymphoma Clinical Trial
Official title:
A Phase I Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral CUDC-427, an Antagonist of Inhibitors of Apoptosis (IAP) Proteins, When Administered in Subjects With Advanced and Refractory Solid Tumors or Lymphoma
This is a phase I, open-label, dose-escalation study of CUDC-427 in patients with advanced or refractory solid tumors or lymphoma. CUDC-427 is a drug that is designed to antagonize proteins that prevent or interfere with cell death. The study is designed to assess the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-cancer activity of CUDC-427.
This is a Phase I, open-label, multicenter, dose-escalation study to evaluate the safety and
tolerability of CUDC-427 as a single agent administered orally, in subjects with advanced
and refractory solid tumors or lymphoma.
Sequential dose escalation cohorts of oral CUDC-427 are planned. Subject enrollment and dose
escalation will proceed according to a standard 3+3 design. In the absence of intolerable
toxicity, each subject will receive a minimum of 1 cycle (21 days) of study treatment, and
may continue to receive additional cycles until disease progression has been documented or
other treatment discontinuation criteria have been met.
No intrasubject dose escalation will be allowed. During the dose escalation phase, up to 3
additional subjects may be enrolled at previously cleared dose levels to better define the
safety, tolerability and activity of the study treatment. Similarly, an MTD expansion cohort
of up to 12 evaluable subjects may also be enrolled.
Safety and tolerability will be assessed by the incidence and severity of adverse events as
assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE v4.03). A Safety
Review Committee comprised of the Medical Monitor, Principal Investigators, and Sponsor
representatives, will be convened to review safety information and to decide upon dose
escalation and further subject enrollment.
The antitumor activity of study treatment will be assessed according to the Response
Evaluation Criteria in Solid Tumors (RECIST v1.1), or the Revised Response Criteria for
Malignant Lymphoma as appropriate for each subject's tumor type.
Exploratory biological markers of CUDC-427 activity will be assessed in tumor samples (where
available), peripheral blood mononuclear cells (PBMC) and plasma.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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