Condition category
Cancer
Date applied
08/07/2013
Date assigned
16/09/2013
Last edited
17/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer 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

Prof Ignace Vergote

ORCID ID

Contact details

University Hospital Leuven (K.U.Leuven)
Gynaecological Oncology Herestraat 49
Leuven
3000
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL1-78454-003

Study information

Scientific title

Phase I study of oral administration of S 78454 given with a fixed dose infusion of pegylated liposomal doxorubicin in the treatment of primary platinum-resistant and partially platinum-sensitive, epithelial ovarian, fallopian tube or primary peritoneal carcinoma

Acronym

Study hypothesis

To establish the safety profile and the recommended Phase II dose of S 78454 in combination with a fixed dose infusion of pegylated liposomal doxorubicin.

On 13/11/2014 the anticipated end date was changed from 01/12/2014 to 30/12/2015.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Multicentric non-randomised open dose escalation Phase I study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Primary epithelial ovarian, fallopian tube or primary peritoneal carcinoma

Intervention

1. Capsules containing 20 mg and 100 mg of S 78454 administered orally. Treatment duration is at the discretion of the investigator.
2. Fixed dose infusion of 40 mg/m² of pegylated liposomal doxorubicin

Intervention type

Drug

Phase

Phase I

Drug names

S 78454

Primary outcome measures

1. Dose limiting toxicity (DLT) at each visit of cycle 1 and maximum tolerated dose (MTD) measured by Adverse Events monitoring
2. Safety profile at each visit measured by Adverse events monitoring

Secondary outcome measures

1. Tumour response evaluation every 2 cycles by imaging and every cycle by blood test
2. Pharmacokinetic and pharmacodynamic parameters during cycle1 measured using blood samples

Overall trial start date

01/12/2010

Overall trial end date

30/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patient aged 18 years or above
2. Histologically confirmed diagnosis of advanced relapsed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, with measurable and evaluable disease
3. Platinum resistant and partially platinum sensitive tumour
4. Ability to swallow oral capsule(s) without difficulty
5. Estimated life expectancy of more than 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
7. Adequate haematological, renal and hepatic functions

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

70

Participant exclusion criteria

1. Pregnant or breast-feeding women, women for whom fertility function has been preserved without effective contraception
2. Major surgery within previous 4 weeks
3. Chemotherapy within previous 3 weeks (6 weeks in case of nitrosoureas)
4. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
5. Immunotherapy or hormonotherapy within previous 2 weeks, except stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, stable mitotane for adrenal carcinoma or oral contraceptives or hormonal replacement therapy
6. Risk factors for, or use of drugs known to prolong QTc interval and that may be associated with Torsades de Pointes
7. Patients treated by valproic acid within previous 5 days before

Recruitment start date

01/12/2010

Recruitment end date

30/12/2015

Locations

Countries of recruitment

Belgium, France, Italy

Trial participating centre

University Hospital Leuven (K.U.Leuven)
Leuven
3000
Belgium

Sponsor information

Organisation

Pharmacyclics LLC (USA)

Sponsor details

999 East Arques Avenue
Sunnyvale
94085
United States of America

Sponsor type

Industry

Website

www.pharmacyclics.com

Funders

Funder type

Industry

Funder name

Pharmacyclics LLC (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

Sponsoring/funding responsibility for the S 78454 project was transferred from Servier, France to Pharmacyclics, USA on 23/11/2014.