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Completed

NCT Number: NCT02022098

Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial

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.

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Key information

Conditions

Squamous Cell Carcinoma of the Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Bretagne Sud - HÔPITAL DU SCORFF, Lorient, BP 2233, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

Cisplatin

Drug

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 names: Concomitant Chemotherapy

Radiotherapy

Radiation

Standard fraction radiotherapy to the primary tumour will be delivered daily for 5 days per week over 7 weeks.

Other names: Concomitant Radiotherapy

Debio 1143

Drug

Debio 1143 solution

Placebo

Drug

Matching placebo solution

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. Phase II: Locoregional control rate at 6 months and one year after completion of CRT

    Time frame: within 5 years

  5. 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

  6. Phase II: Distant relapse rate at six months, one year and 18 months after completion of CRT

    Time frame: within 5 years

  7. Phase II: Disease specific survival rate one year and at 2 years as of initiation of CRT

    Time frame: within 5 years

  8. Phase II: Overall survival rate at one year and at 2 years as of initiation of CRT

    Time frame: within 5 years

  9. Phase II: Number of participants with clinically significant change in vital signs during participation in the trial

    Time frame: within 5 years

  10. Phase II: Number of participants with Serious Adverse Events

    Time frame: within 5 years

  11. 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

  12. 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

  13. 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

  14. Phase II: Number of participants with treatment changes due to AEs

    Time frame: within 5 years

    Categories: Treatment discontinuation, Treatment modification

Sponsors and collaborators

Lead sponsor

Debiopharm International SA

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2020
Study completion
2022
First posted
Dec 27, 2013
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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