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Squamous Cell Carcinoma of the Head and NeckNCT02022098

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

A study testing Cisplatin, Radiotherapy and Debio 1143 in people with Squamous Cell Carcinoma of the Head and Neck, run by Debiopharm International SA at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Cisplatin, Radiotherapy and Debio 1143
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
19 sitesin 2 countries
Study dates
Oct 2013to 28 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

France17 sites

  • C.H.U. Sud Amiens

    Amiens, 80054

  • Institut Sainte-Catherine

    Avignon, 84918

  • Centre Jean Perrin

    Clermont-Ferrand, BP 392

  • CHU Grenoble

    Grenoble, BP 217

  • CHD Vendée

    La Roche-sur-Yon, F- 85925

  • Centre Guillaume le Conquérant

    Le Havre, 76600

  • Centre Jean Bernard

    Le Mans

  • Centre Hospitalier de Bretagne Sud - HÔPITAL DU SCORFF

    Lorient, BP 2233, 56322

  • Hôpital Nord Franche-Comté

    Montbéliard, 25200

  • ICM - Val D'Aurelle

    Montpellier, 34298

  • Institut Curie

    Paris, 75248

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut de Cancérologie de l'Ouest (ICO) René Gauducheau

    Saint-Herblain, BP 217

  • Institut de Cancérologie Lucien Neuwirth (ICLN)

    Saint-Priest-en-Jarez, BP 60008

  • Institut Claudius Regaud

    Toulouse, 31052

  • L'Institut de Cancérologie de Lorraine (ICL) Alexis Vautrin

    Vandœuvre-lès-Nancy, CS 30519

  • Institut Gustave Roussy

    Villejuif, 94000

Other trials in France

Switzerland2 sites

  • Inselspital Bern, Universitätsklinik für Radio-Onkologie, Freiburgstrasse 4

    Bern, 3010

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, 1011

Other trials in Switzerland

About this study

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.

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.

Being tested
Cisplatin, Radiotherapy, Debio 1143, Placebo
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Concomitant Chemotherapy

    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.

  • RadiotherapyRadiation

    Also called Concomitant Radiotherapy

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

  • Debio 1143Drug

    Debio 1143 solution

  • PlaceboDrug

    Matching placebo solution

Study groups in NCT02022098
Study groupRoleWhat they receive
Debio 1143ExperimentalIn 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).
Receives: Drug: Cisplatin; Radiation: Radiotherapy; Drug: Debio 1143
PlaceboPlacebo comparatorIn 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).
Receives: Drug: Cisplatin; Radiation: Radiotherapy; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase II: Percentage of participants achieving Locoregional Control (LRC) at 18 months from the end of chemo-radiation therapy (CRT)

    Measured: within 4 years

Secondary outcomes (14)

  1. Phase II: Complete Response Rate (by RECIST version 1.1) at six months after completion of chemo-radiation therapy (CRT) therapy

    Measured: within 5 years

  2. Phase II: Best Overall response rate, Disease Control rate and Response Rate after 10 weeks from the end of CRT

    Measured: within 5 years

  3. Phase II: Best Overall response rate, Disease Control rate and Response Rate after 6 months from the end of CRT

    Measured: within 5 years

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

    Measured: within 5 years

  5. Phase II: Progression free survival rate at one year, 18 months and at 2 years as of initiation of CRT

    Measured: within 5 years

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

    Measured: within 5 years

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

    Measured: within 5 years

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

    Measured: within 5 years

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

    Measured: within 5 years

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

    Measured: within 5 years

  11. Phase II: Number of participants with Adverse Events (AEs)

    Categories will be based on severity graded according to NCI-CTCAE version 4 criteria

    Measured: within 5 years

  12. Phase II: Number of participants with Laboratory Abnormalities

    Categories will be based on severity graded according to NCI-CTCAE version 4 criteria

    Measured: within 5 years

  13. Phase II: Number of participants with Late Toxicity as of initiation of CRT

    Categories: at 1 year, at 2 years

    Measured: within 5 years

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

    Categories: Treatment discontinuation, Treatment modification

    Measured: within 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJul 2020
  4. Study completion28 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02022098
Sponsor's protocol ID
Debio 1143-201
Status last verified
Jun 2022
First submitted
13 Dec 2013
Last updated
23 Jun 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Vugmeyster Y, Ravula A, Rouits E, Diderichsen PM, Kleijn HJ, Koenig A, Wang X, Schroeder A, Goteti K, Venkatakrishnan K. Model-Informed Selection of the Recommended Phase III Dose of the Inhibitor of Apoptosis Protein Inhibitor, Xevinapant, in Combination with Cisplatin and Concurrent Radiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck. Clin Pharmacol Ther. 2024 Jan;115(1):52-61. doi: 10.1002/cpt.3065. Epub 2023 Oct 23.

    PubMed 37777832

  • Tao Y, Sun XS, Pointreau Y, Tourneau CL, Sire C, Gollmer K, Crompton P, Bourhis J. Long-term results from a clinical study of xevinapant plus chemoradiotherapy in people with high-risk locally advanced squamous cell carcinoma of the head and neck: a plain language summary. Future Oncol. 2023 Aug;19(26):1769-1776. doi: 10.2217/fon-2023-0322. Epub 2023 Jul 13.

    PubMed 37439181

  • Tao Y, Sun XS, Pointreau Y, Le Tourneau C, Sire C, Kaminsky MC, Coutte A, Alfonsi M, Calderon B, Boisselier P, Martin L, Miroir J, Ramee JF, Delord JP, Clatot F, Rolland F, Villa J, Magne N, Elicin O, Gherga E, Nguyen F, Lafond C, Bera G, Calugaru V, Geoffrois L, Chauffert B, Damstrup L, Crompton P, Ennaji A, Gollmer K, Nauwelaerts H, Bourhis J. Extended follow-up of a phase 2 trial of xevinapant plus chemoradiotherapy in high-risk locally advanced squamous cell carcinoma of the head and neck: a randomised clinical trial. Eur J Cancer. 2023 Apr;183:24-37. doi: 10.1016/j.ejca.2022.12.015. Epub 2023 Jan 9.

    PubMed 36796234

  • Sun XS, Tao Y, Le Tourneau C, Pointreau Y, Sire C, Kaminsky MC, Coutte A, Alfonsi M, Boisselier P, Martin L, Miroir J, Ramee JF, Delord JP, Clatot F, Rolland F, Villa J, Magne N, Elicin O, Gherga E, Nguyen F, Lafond C, Bera G, Calugaru V, Geoffrois L, Chauffert B, Zubel A, Zanna C, Brienza S, Crompton P, Rouits E, Gollmer K, Szyldergemajn S, Bourhis J. Debio 1143 and high-dose cisplatin chemoradiotherapy in high-risk locoregionally advanced squamous cell carcinoma of the head and neck: a double-blind, multicentre, randomised, phase 2 study. Lancet Oncol. 2020 Sep;21(9):1173-1187. doi: 10.1016/S1470-2045(20)30327-2. Epub 2020 Aug 3.

    PubMed 32758455

Questions about this trial

What is this clinical trial studying?

A study testing Cisplatin, Radiotherapy and Debio 1143 in people with Squamous Cell Carcinoma of the Head and Neck, run by Debiopharm International SA at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02022098, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.

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