Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Registration Number
- NCT02022098
- Lead Sponsor
- Debiopharm International SA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
- Meets protocol-specified criteria for qualification and contraception
- Is willing and able to comply with study procedures and restrictions related to food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
-
Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
-
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff;
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
- the analysis of results
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Debio 1143 Radiotherapy In addition to Cisplatin and Radiotherapy, Debio 1143 in solution form will be administered orally or by feeding tube (while fasting) daily for 14 days every three weeks (on days 1-14, 22-35 and 43-56). Debio 1143 Debio 1143 In addition to Cisplatin and Radiotherapy, Debio 1143 in solution form will be administered orally or by feeding tube (while fasting) daily for 14 days every three weeks (on days 1-14, 22-35 and 43-56). Placebo Radiotherapy In addition to Cisplatin and Radiotherapy, matching placebo in solution form will be administered orally or by feeding tube (while fasting) daily for 14 days every three weeks (on days 1-14, 22-35 and 43-56). Placebo Placebo In addition to Cisplatin and Radiotherapy, matching placebo in solution form will be administered orally or by feeding tube (while fasting) daily for 14 days every three weeks (on days 1-14, 22-35 and 43-56). Debio 1143 Cisplatin In addition to Cisplatin and Radiotherapy, Debio 1143 in solution form will be administered orally or by feeding tube (while fasting) daily for 14 days every three weeks (on days 1-14, 22-35 and 43-56). Placebo Cisplatin In addition to Cisplatin and Radiotherapy, matching placebo in solution form will be administered orally or by feeding tube (while fasting) daily for 14 days every three weeks (on days 1-14, 22-35 and 43-56).
- Primary Outcome Measures
Name Time Method Phase II: Percentage of participants achieving Locoregional Control (LRC) at 18 months from the end of chemo-radiation therapy (CRT) within 4 years
- Secondary Outcome Measures
Name Time Method Phase II: Best Overall response rate, Disease Control rate and Response Rate after 10 weeks from the end of CRT within 5 years Phase II: Locoregional control rate at 6 months and one year after completion of CRT within 5 years Phase II: Progression free survival rate at one year, 18 months and at 2 years as of initiation of CRT within 5 years Phase II: Distant relapse rate at six months, one year and 18 months after completion of CRT within 5 years Phase II: Disease specific survival rate one year and at 2 years as of initiation of CRT within 5 years Phase II: Overall survival rate at one year and at 2 years as of initiation of CRT within 5 years Phase II: Number of participants with clinically significant change in vital signs during participation in the trial within 5 years Phase II: Number of participants with Serious Adverse Events within 5 years Phase II: Number of participants with Adverse Events (AEs) within 5 years Categories will be based on severity graded according to NCI-CTCAE version 4 criteria
Phase II: Number of participants with Laboratory Abnormalities within 5 years Categories will be based on severity graded according to NCI-CTCAE version 4 criteria
Phase II: Number of participants with Late Toxicity as of initiation of CRT within 5 years Categories: at 1 year, at 2 years
Phase II: Number of participants with treatment changes due to AEs within 5 years Categories: Treatment discontinuation, Treatment modification
Phase II: Complete Response Rate (by RECIST version 1.1) at six months after completion of chemo-radiation therapy (CRT) therapy within 5 years Phase II: Best Overall response rate, Disease Control rate and Response Rate after 6 months from the end of CRT within 5 years
Trial Locations
- Locations (19)
C.H.U. Sud Amiens
🇫🇷Amiens, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand Cedex 01, France
Centre Hospitalier de Bretagne Sud - HÔPITAL DU SCORFF
🇫🇷Lorient, Bp 2233, France
CHD Vendée
🇫🇷La Roche Sur Yon cedex 9, France
Institut Sainte-Catherine
🇫🇷Avignon Cedex 9, France
CHU Grenoble
🇫🇷Grenoble, France
Hôpital Nord Franche-Comté
🇫🇷Montbéliard, France
Centre Guillaume le Conquérant
🇫🇷Le Havre, France
Centre Henri Becquerel
🇫🇷Rouen, France
ICM - Val D'Aurelle
🇫🇷Montpellier, France
Centre Jean Bernard
🇫🇷Le Mans, France
Institut Curie
🇫🇷Paris, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Institut de Cancérologie de l'Ouest (ICO) René Gauducheau
🇫🇷Saint-Herblain, France
Institut de Cancérologie Lucien Neuwirth (ICLN)
🇫🇷Saint-Priest en Jarez, France
Inselspital Bern, Universitätsklinik für Radio-Onkologie, Freiburgstrasse 4
🇨ðŸ‡Bern, Switzerland
L'Institut de Cancérologie de Lorraine (ICL) Alexis Vautrin
🇫🇷Vandoeuvre-lès-Nancy, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Hospitalier Universitaire Vaudois (CHUV)
🇨ðŸ‡Lausanne, Switzerland