Spots Global Cancer Trial Database for Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors
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Trial Identification
Brief Title: Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors
Official Title: A Phase 1 Study of Oral Debio 0123 in Combination With Carboplatin in Patients With Advanced Solid Tumors
Study ID: NCT03968653
Conditions
Study Description
Brief Summary: This study has two parts: Dose Escalation and Dose Expansion. The primary objective of the study, in the Dose Escalation Part is to determine the recommended phase 2 dose (RP2D) of Debio 0123 when administered in combination with carboplatin in participants with advanced solid tumors that recurred or progressed after prior cisplatin or carboplatin containing therapy and for which no standard therapy of proven benefit is available. The primary objective of the study, in the Dose Expansion Part is to characterize the safety and tolerability of Debio 0123 when administered in combination with carboplatin at the RP2D determined during the dose escalation part of the study and to evaluate the preliminary antitumor activity of Debio 0123 when administered in combination with carboplatin.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Medical Center Groningen, Groningen, , Netherlands
Leiden University Medical Center, Dept. of Clinical Oncology, Leiden, , Netherlands
Radboud university medical center, Nijmegen, , Netherlands
Hospital Vall Hebrón, Unidad de Investigación en Terapia Molecular (UITM), Barcelona, , Spain
Contact Details
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