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Trial record 1 of 1 for:    NCT02022098
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Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT02022098
First received: December 13, 2013
Last updated: August 21, 2017
Last verified: August 2017
  Purpose

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.


Condition Intervention
Squamous Cell Carcinoma of the Head and Neck Drug: Cisplatin Radiation: Radiotherapy Drug: Debio 1143 Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I/II Randomized Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Antitumor Activity of Debio 1143 Combined With Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.

Resource links provided by NLM:


Further study details as provided by Debiopharm International SA:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: within 5 years ]
    Categories: at 1 year, at 2 years

  • Phase II: Number of participants with treatment changes due to AEs [ Time Frame: within 5 years ]
    Categories: Treatment discontinuation, Treatment modification


Estimated Enrollment: 118
Study Start Date: October 2013
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Drug: Cisplatin
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.
Other Name: Concomitant Chemotherapy
Radiation: Radiotherapy
Standard fraction radiotherapy to the primary tumour will be delivered daily for 5 days per week over 7 weeks.
Other Name: Concomitant Radiotherapy
Drug: Debio 1143
Debio 1143 solution
Placebo Comparator: 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).
Drug: Cisplatin
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.
Other Name: Concomitant Chemotherapy
Radiation: Radiotherapy
Standard fraction radiotherapy to the primary tumour will be delivered daily for 5 days per week over 7 weeks.
Other Name: Concomitant Radiotherapy
Drug: Placebo
Matching placebo solution

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    1. the safety or well-being of the participant or study staff;
    2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
    3. the analysis of results
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022098

Locations
France
Centre Hospitalier de Bretagne Sud - HÔPITAL DU SCORFF
Lorient, Bp 2233, France, 56322
C.H.U. Sud Amiens
Amiens, France, 80054
ICO Paul Papin
Angers Cedex 02, France, CS 10059
Institut Sainte-Catherine
Avignon Cedex 9, France, 84918
CHU Côte de Nacre
CAEN Cedex 09, France, CS30001
Centre Jean Perrin
Clermont-Ferrand Cedex 01, France, BP 392
Centre Georges François Leclerc
Dijon, France, 21079
CHU Grenoble
Grenoble, France, BP 217
CHD Vendée
La Roche Sur Yon cedex 9, France, F- 85925
Centre Guillaume le Conquérant
Le Havre, France, 76600
Centre Jean Bernard
Le Mans, France
Centre Léon Berard
Lyon, France
Hôpital Nord Franche-Comté
Montbéliard, France, 25200
ICM - Val D'Aurelle
Montpellier, France, 34298
Institut Curie
Paris, France, 75248
Centre Henri Becquerel
Rouen, France, 76038
Institut de Cancérologie de l'Ouest (ICO) René Gauducheau
Saint-Herblain, France, BP 217
Institut de Cancérologie Lucien Neuwirth (ICLN)
Saint-Priest en Jarez, France, BP 60008
Institut Claudius Regaud
Toulouse, France, 31052
L'Institut de Cancérologie de Lorraine (ICL) Alexis Vautrin
Vandoeuvre-lès-Nancy, France, CS 30519
Institut Gustave Roussy
Villejuif, France, 94000
Switzerland
Inselspital Bern, Universitätsklinik für Radio-Onkologie, Freiburgstrasse 4
Bern, Switzerland, 3010
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Debiopharm International SA
  More Information

Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT02022098     History of Changes
Other Study ID Numbers: Debio 1143-201
Study First Received: December 13, 2013
Last Updated: August 21, 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Pharmaceutical Solutions
Cisplatin
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 19, 2017