Condition category
Cancer
Date applied
22/05/2015
Date assigned
30/06/2015
Last edited
26/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Dr Patrick Schöffski

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2014-002023-10

ClinicalTrials.gov number

Protocol/serial number

CL1-81694-001

Study information

Scientific title

Phase I dose-escalation study of S 81694 administered intravenously in adult patients with advanced/metastatic solid tumors

Acronym

Study hypothesis

To determine the maximum tolerated dose and the associated dose-limiting toxicities of S 81694

Ethics approval

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

Study design

Phase I multicentre open-label non-randomised non-comparative study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

S 81694

Primary outcome measures

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

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 trial start date

23/12/2014

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

84

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 yndrome(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

03/07/2015

Recruitment end date

08/12/2017

Locations

Countries of recruitment

Belgium, Netherlands

Trial participating centre

Medical Oncology Clinic
Institut Jules Bordet Université Libre de Bruxelles
Brussels
-
Belgium

Trial participating centre

Leuven Cancer Institute
Department of General Medical Oncology University Hospitals Leuven and Laboratory of Experimental Oncology Department of Oncology KU Leuven
-
Belgium

Trial participating centre

Erasmus MC Cancer Institute
-
Netherlands

Sponsor information

Organisation

Institut de Recherche Internationales Servier

Sponsor details

50
rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

ADIR

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We will comply with regulatory requirements

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes