A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Rituximab in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

Official Title

A Phase I, Multi-centre, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed OR Refractory Non-Hodgkin Lymphomas (R/R NHL).

Summary:

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.

Trial Description

Primary Outcome:

  • Dose Limiting Toxicity (DLT)
  • Maximum tolerated dose (MTD)
  • Incidence of Adverse Events (AEs)
Secondary Outcome:
  • Pharmacokinetics - Maximum observed plasma concentration (Cmax)
  • Pharmacokinetics - Area under the plasma concentration-time curve (AUC)
  • Pharmacokinetics - Time to Cmax (Tmax)
  • Pharmacokinetics - Terminal-phase elimination half-life (t1/2)
  • Pharmacokinetics - Apparent total clearance of the drug from plasma after oral administration (CL/F)
  • Pharmacokinetics: Apparent volume of distribution during terminal phase after non-intravenous administration (V/F)
  • Objective response rate (ORR)
  • Time to response (TTR)
  • Duration of response (DoR)
  • Progression free survival: Time from first dose of CC-99282 to the first occurrence of disease progression or death from any cause
  • Overall survival: Time from first dose of CC-99282 to death from any cause
Participants with relapsed or refractory non-Hodgkin's lymphomas (R/R NHL) who have failed at least 2 lines of therapy (or have received at least one prior line of standard therapy and are not eligible for any other therapy). The dose escalation will evaluate the safety and tolerability of escalating doses of CC-99282 in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and/or relapsed or refractory follicular lymphoma (R/R FL) participants to determine the maximum tolerated dose (MTD) of CC-99282 as monotherapy. The dose expansion will further evaluate the safety and preliminary efficacy of single agent CC-99282 administered at or below MTD in subjects with R/R DLBCL and NHL. Part B will also evaluate the safety and preliminary efficacy of CC-99282 in combination with rituximab in participants with R/R DLBCL and R/R FL.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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