Condition: Locally-advanced Rectal Cancer · Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Compare two arms: * Chemotherapy followed by tolinapant (ASTX660) in combination with Long-Course Radio Chemotherapy (LCRT), and * Tolinapant (ASTX660) in combination with Short-Course Radiotherapy (SCRT) followed by chemotherapy For each patient, the treatment arm will be allocated on the following basis: patients will be allocated to the chemotherapy followed by LCRT arm unless they present at least one of the following criteria: contraindication to receive mFOLFIRINOX (including intolerance to irinotecan and UGT1A1\*28 polymorphism), age \> 75, general condition incompatible with the radiotherapy schedule of LCRT. In such case, patients will be allocated to the SCRT arm. Tolinapant (ASTX660) will be administered orally once a day for 7 consecutive days every other week during 10 weeks (One week On / One week Off during 10 weeks). Both treatment arms will have a dose escalation part to determine the MTD and/or RP2D, followed by an expansion part where up to 21 subjects will be dosed at the RP2D. Both arms will enroll simultaneously.
This description comes directly from the study's public registry record.
Eric DEUTSCH, MD, PhD · +33 (0)1 42 11 65 73 · Eric.DEUTSCH@gustaveroussy.fr
Catherine RICHON · +33 (0)1 42 11 23 44 · catherine.richon@gustaveroussy.fr
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| Centre Léon Bérard | Lyon, Rhöne, France | Not Yet Recruiting |
| Gustave Roussy | Villejuif, Val De Marne, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05912075