Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial
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| ClinicalTrials.gov Identifier: NCT02022098 |
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Recruitment Status :
Completed
First Posted : December 27, 2013
Last Update Posted : June 23, 2022
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Drug: Cisplatin Radiation: Radiotherapy Drug: Debio 1143 Drug: Placebo | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 144 participants |
| 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. |
| Actual Study Start Date : | October 2013 |
| Actual Primary Completion Date : | July 2020 |
| Actual Study Completion Date : | April 28, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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).
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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 |
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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).
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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 |
- 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) [ 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
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022098
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| Responsible Party: | Debiopharm International SA |
| ClinicalTrials.gov Identifier: | NCT02022098 |
| Other Study ID Numbers: |
Debio 1143-201 |
| First Posted: | December 27, 2013 Key Record Dates |
| Last Update Posted: | June 23, 2022 |
| Last Verified: | June 2022 |
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Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms by Site Cisplatin Antineoplastic Agents |