The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become common, particularly in the treatment of cancer. Because traditional trials are designed to evaluate one agent at a time, the evaluation of therapies in combination requires specialized trial designs. In place of the traditional separate phase I and II trials, this trial uses a single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of combination dose levels, and select the optimal combination dose. Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and neck cancer. The trial begins with an initial period of dose escalation (Phase I) to investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in combination with CRT. Using the MTD determined in the Phase I portion, the randomized phase II trial in 94 participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to evaluate the efficacy and safety of Debio 1143.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
A total of three cycles of cisplatin will be administered in a 1-hour IV infusion on days 2, 23 and 44. Cisplatin will be administered 0.5 hours after Debio 1143.
Standard fraction radiotherapy to the primary tumour will be delivered daily for 5 days per week over 7 weeks.
Debio 1143 solution
Matching placebo solution
Centre Hospitalier de Bretagne Sud - HÔPITAL DU SCORFF
Lorient, BP 2233, France
C.H.U. Sud Amiens
Amiens, France
Institut Sainte-Catherine
Avignon, France
Centre Jean Perrin
Clermont-Ferrand, France
CHU Grenoble
Grenoble, France
CHD Vendée
La Roche-sur-Yon, France
Centre Guillaume le Conquérant
Le Havre, France
Centre Jean Bernard
Le Mans, France
Hôpital Nord Franche-Comté
Montbéliard, France
ICM - Val D'Aurelle
Montpellier, France
...and 9 more locations
Phase II: Percentage of participants achieving Locoregional Control (LRC) at 18 months from the end of chemo-radiation therapy (CRT)
Time frame: within 4 years
Phase II: Complete Response Rate (by RECIST version 1.1) at six months after completion of chemo-radiation therapy (CRT) therapy
Time frame: within 5 years
Phase II: Best Overall response rate, Disease Control rate and Response Rate after 10 weeks from the end of CRT
Time frame: within 5 years
Phase II: Best Overall response rate, Disease Control rate and Response Rate after 6 months from the end of CRT
Time frame: within 5 years
Phase II: Locoregional control rate at 6 months and one year after completion of CRT
Time frame: within 5 years
Phase II: Progression free survival rate at one year, 18 months and at 2 years as of initiation of CRT
Time frame: within 5 years
Phase II: Distant relapse rate at six months, one year and 18 months after completion of CRT
Time frame: within 5 years
Phase II: Disease specific survival rate one year and at 2 years as of initiation of CRT
Time frame: within 5 years
Phase II: Overall survival rate at one year and at 2 years as of initiation of CRT
Time frame: within 5 years
Phase II: Number of participants with clinically significant change in vital signs during participation in the trial
Time frame: within 5 years
Phase II: Number of participants with Serious Adverse Events
Time frame: within 5 years
Phase II: Number of participants with Adverse Events (AEs)
Categories will be based on severity graded according to NCI-CTCAE version 4 criteria
Time frame: within 5 years
Phase II: Number of participants with Laboratory Abnormalities
Categories will be based on severity graded according to NCI-CTCAE version 4 criteria
Time frame: within 5 years
Phase II: Number of participants with Late Toxicity as of initiation of CRT
Categories: at 1 year, at 2 years
Time frame: within 5 years
Phase II: Number of participants with treatment changes due to AEs
Categories: Treatment discontinuation, Treatment modification
Time frame: within 5 years
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