Study with S 81694 in perfusion in patients with solid tumors
| ISRCTN | ISRCTN35641359 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35641359 |
| EudraCT/CTIS number | 2014-002023-10 |
| ClinicalTrials.gov number | N/A |
| Secondary identifying numbers | CL1-81694-001 |
- Submission date
- 22/05/2015
- Registration date
- 30/06/2015
- Last edited
- 16/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Not provided at time of registration and not expected to be available in the future
Contact information
Scientific
Department of General Medical Oncology
Leuven Cancer Institute
University Hospitals Leuven and Laboratory of Experimental Oncology
Department of Oncology
KU Leuven
Herestrat 49
Leuven
B-3000
Belgium
Public
50, rue Carnot
Suresnes
92284
France
| Phone | 00331 5572 4366 |
|---|---|
| clinicaltrialmanagement@servier.com |
Study information
| Study design | Phase I multicentre open-label non-randomised non-comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Phase I dose-escalation study of S 81694 administered intravenously in adult patients with advanced/metastatic solid tumors |
| Study hypothesis | To determine the maximum tolerated dose and the associated dose-limiting toxicities of S 81694 |
| Ethics approval(s) | 1. Netherlands: Medisch Ethische Toetsings Commissie Erasmus MC, 07/10/2015, ref: NL51604.078.15. 2. Belgium: Commissie Medische Ethiek UZ Leuven and the Comité d'éthique Institut Bordet, 27/07/2015 |
| Condition | Advanced/metastatic solid tumors |
| Intervention | Vial containing 30 mg of powder for solution for infusion. From 12 mg/m² per cycle to the maximum tolerated dose. Intravenous use. Until disease progression or occurrence of unacceptable toxicity. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | S 81694 |
| Primary outcome measure | Maximum tolerated dose and dose limiting toxicities from the day of the first dose administration in cycle 1 until the date of the first dose administration in cycle 2. |
| Secondary outcome measures | Current secondary outcome measures as of 19/03/2020: 1. Safety and tolerability profile of S 81694 from the informed consent signature to 30 days after the last treatment administration 2. Determination of the recommended phase II dose 3. Pharmacokinetics profile of S 81694 and its metabolite(s) in plasma and urine during cycle 1 and cycle 2 Previous secondary outcome measures: 1. Safety and tolerability profile of S 81694 from the informed consent signature to 30 days after the last treatment administration 2. Determination of the recommended phase II dose 3. Pharmacokinetics profile of S 81694 and its metabolite(s) in plasma and urine during cycle 1 |
| Overall study start date | 23/12/2014 |
| Overall study end date | 03/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 72 |
| Total final enrolment | 39 |
| Participant inclusion criteria | 1. Male or female patients with age ≥ 18 years 2. Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumour in patients for whom no effective standard therapy is available or suitable 3. Elapsed time of 4 weeks or, in absence of toxicity, of 5 half-lives between the completion of the prior antineoplastic therapy including biologic, immunologic or targeted anticancer therapy and S 81694 first administration 4. Elapsed time of 6 weeks for nitrosoureas or mitomycin C 5. Resolution (return to baseline) or return to NCI CTCAE Grade ≤ 1 of all acute toxicities due to prior anticancer therapy except alopecia, grade 2 paraesthesia, grade 2 hyper- or hypothyroidism and other non-clinically significant adverse events 6. ECOG (WHO) performance status 0-1 7. Patient must use effective contraception |
| Participant exclusion criteria | 1. Patients who have undergone treatment with high-dose chemotherapy requiring progenitor cell transplantation 2. Episode(s) of clinically relevant active bleeding in the past 3 weeks 3. Known history of haemolytic anaemia (including G6PD deficiency), thrombotic thrombocytopenic purpura (TTP), microangiopathic haemolytic anaemia (MAHA), haemolytic uremic syndrome(HUS) 4. Clinically significant respiratory or metabolic diseases uncontrolled by medication 5. Patients with uncontrolled high blood pressure 6. Presence of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT syndrome) |
| Recruitment start date | 05/10/2015 |
| Recruitment end date | 07/01/2019 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centres
Université Libre de Bruxelles
Brussels
-
Belgium
University Hospitals Leuven and Laboratory of Experimental Oncology
Department of Oncology
KU Leuven
-
Belgium
Netherlands
Sponsor information
Industry
50, rue Carnot
Suresnes
92284
France
| Website | https://clinicaltrials.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 08/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication and dissemination plan as of 28/09/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ after the Marketing Authorisation has been granted. Previous publication and dissemination plan: We will comply with regulatory requirements Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study IPD Sharing Plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ after the Marketing Authorisation has been granted. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Plain English results | No | Yes | |||
| Results article | 11/05/2022 | 16/05/2022 | Yes | No |
Editorial Notes
16/05/2022: Publication reference added.
08/07/2020: Links to basic results (scientific) and results (plain English) added. The overall trial end date was changed from 08/07/2019 to 03/07/2019.
19/03/2020: The following changes have been made:
1. The recruitment end date has been changed from 06/02/2019 to 07/01/2019.
2. The overall trial end date has been changed from 07/05/2019 to 08/07/2019.
3. The intention to publish date has been changed from 07/05/2020 to 08/07/2020.
4. The secondary outcome measures have been updated.
5. The public contact has been updated.
06/11/2019: Internal review.
25/03/2019: The following changes were made:
1. The recruitment end date was changed from 28/02/2019 to 06/02/2019.
2. The total final enrolment was added.
3. The overall trial end date was changed from 29/02/2020 to 07/05/2019.
4. The intention to publish date was changed from 28/02/2021 to 07/05/2020.
22/02/2019: Internal review.
28/09/2018: The following changes were made to the trial record:
1. The target number of participants and total target enrolment were updated from 84 to 72
2. The publication and dissemination plan was updated
3. The intention to publish date was added
4. The participant level data was updated from 'Other' to 'To be made available at a later date'
5. The contact details were updated
15/03/2018: The overall trial end date has been updated from 31/10/2019 to 29/02/2020. The publication plan is updated. An IPD sharing plan has been added.
19/12/2016: The overall trial end date has been updated from 30/09/2016 to 31/10/2019 and the recruitment dates have been updated from 03/07/2015 - 08/12/2017 to 05/10/2015 - 28/02/2019.
