Cancer Clinical Trial
Official title:
Phase I Dose-escalation, Pharmacokinetic and Pharmacodynamic Study of Debio 0932, a Novel Hsp90-inhibitor, Administered Orally, in Patients With Advanced Solid Tumours or Lymphoma
The purpose of this study is to determine the maximum tolerated dose of Debio 0932 when administered orally, every-other-day or daily during the first 30 days, in patients with solid tumours or lymphoma.
This is an open-label, non-randomised, dose-escalation phase I, pharmacokinetic and
pharmacodynamic study in patients with advanced and/or refractory malignancies (solid
tumours or lymphoma), to determine the maximum tolerated doses (MTD) of Debio 0932
administered orally every-other-day (schedule A) or every day (schedule B) and to assess its
safety profile, pharmakokinetic, antitumor activity and pharmacodynamic biomarkers.
Increments used in dose escalation will be determined according to the maximum grade of
treatment-related adverse events observed during the first 30-day treatment period of each
schedule in the previous in the preceding dose level Once reaching the recommended dose (RD)
for each schedule, up to 40 additional patients will be enrolled and treated at the RD of
the retained schedule, as part of an expansion phase.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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