Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
1
Sites
16
recurrent or metastatic Adenoid Cystic Carcinoma of the Head and Neck
Key facts
- Sponsor
- Groupe Oncologie Radiotherapie Tete Cou
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Nov 2023 → 9 Oct 2024
- Decision date (initial)
- 2023-08-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
recurrent or metastatic Adenoid Cystic Carcinoma of the Head and Neck
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10053231 | Adenoid cystic carcinoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Groupe Oncologie Radiotherapie Tete Cou
- Sponsor organisation
- Groupe Oncologie Radiotherapie Tete Cou
- Address
- 19 Rue Edouard Vaillant
- City
- Tours
- Postcode
- 37000
- Country
- France
Scientific contact point
- Organisation
- Groupe Oncologie Radiotherapie Tete Cou
- Contact name
- Coordinating investigator
Public contact point
- Organisation
- Groupe Oncologie Radiotherapie Tete Cou
- Contact name
- Project manager
Locations
1 EU/EEA country · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 32 | 16 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Regional Universitaire De Tours
Radiation oncology, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Assistance Publique Hopitaux De Marseille
Medical oncology, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Lyon Sud
Medical oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Institut Regional Du Cancer De Montpellier
Medical oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut De Cancerologie Strasbourg Europe
Medical oncology, 17 Rue Albert Calmette, 67200, Strasbourg
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Centre Jean Perrin
Medical oncology, 58 Rue Montalembert, 63000, Clermont-Ferrand
Institut De Cancerologie De L Ouest
Medical oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut Sainte Catherine
Medical oncology, 250 Chemin De Baigne Pieds, 84000, Avignon
Centre Antoine Lacassagne
Medical oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre Francois Baclesse
Surgery, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut Claudius Regaud
Medical oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Oscar Lambret
Medical oncology, 3 Rue Frederic Combemale, 59000, Lille
Centre Hospitalier Universitaire De Bordeaux
Medical oncolgy, 1 Rue Jean Burguet, 33000, Bordeaux
Institut Gustave Roussy
Head and Neck, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De Lorraine
Medical Oncology, 6 Avenue De Bourgogne, Cs 30519, Vandoeuvre Les Nancy Cedex
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-11-29 | 2023-11-29 | 2024-05-15 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-25581
- Halt date
- 2024-05-15
- Planned restart
- 2024-12-01
- Member states concerned
- France
- Publication date
- 2024-05-17
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Explanation
- In response to the severe toxicities observed, a recent meeting of the IDSMC expert committee was convened to reassess the benefit-risk ratio of OBT076. Preliminary findings indicate severe toxicities, particularly cases of febrile neutropenia and severe infusion reactions. Although initial efficacy data have not shown any objective responses yet, the current number of evaluable patients is insufficient for definitive conclusions. Interruption of pre screening, screening and randomization is a recommandation of IDMSC. The steering comittee is in agreement with this recommadation, so inclusion are interrupted until results of interim analysis.
A MUS has been submitted - Follow-up measures
- For the patients already enrolled in the study :
- Adjustment of Infusion Rate: OBT076 administration should last 6 hours for all doses.
- Extended Post-administration Observation: Observation time after OBT076 administration should be extended to at least 2 hours.
- Premedication: Administering premedication dosage, particularly for methylprednisolone (or equivalent), should be increased to 120mg.
- Mandatory Use of filgrastim-type G-CSF instead of the pegylated form. - Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-21 | France | Acceptable 2023-07-28
|
2023-08-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-19 | France | Acceptable | 2024-02-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-13 | France | Acceptable 2024-06-03
|
2024-06-03 |