Condition category
Cancer
Date applied
04/10/2013
Date assigned
09/12/2013
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 Norbert Vey

ORCID ID

Contact details

Institut Paoli Calmettes
232 Boulevard Sainte Marguerite
Marseille CEDEX 9
13273
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL1-78454-007

Study information

Scientific title

Phase I dose escalation study of oral administration of S 78454 given as monotherapy in the treatment of patients with refractory or relapsed acute myeloid leukemia, acute lymphoblastic leukemia or high or intermediary-2 risk myelodysplastic syndrome

Acronym

Study hypothesis

To establish the safety profile and the recommended Phase II dose of S 78454.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

National multicentric dose escalation open Phase I study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.

Condition

Acute myeloid leukemia, acute lymphoblastic leukemia or myelodysplastic syndrome.

Intervention

Capsules containing 20 mg and 100 mg of S 78454 / Oral use / Treatment duration is at the discretion of the investigator

Intervention type

Drug

Phase

Phase I

Drug names

S 78454

Primary outcome measures

1. DLTs and MTDs at the end of cycle 1 - methods used: blood samples, physical examination, bone marrow samples, ECG
2. Safety profile at each visit

Secondary outcome measures

1. Pharmacokinetic and pharmacodynamic evaluations on cycle 1 and cycle 2 by blood sample
2. Response evaluation during the study by blood samples and bone marrow samples

Overall trial start date

15/07/2012

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female patient aged > or equal to 18
2. Ability to swallow oral capsule(s)
3. Estimated life expectancy > 8 weeks
4. ECOG performance status < or equal to 2
5. Adequate renal and hepatic functions
6. Left ventricular ejection fraction within normal limits
7. Patients with AML as defined by WHO 2008 classification, excluding acute promyelocytic leukemia
8. Patients with high or intermediary risk (IPSS int-2) myelodysplastic syndrome (MDS) as defined by WHO 2008 classification and IPSS, who have failed hypomethylating therapy (5 azacytidine)
9. Patients with histologically or cytologically confirmed B-cell ALL as defined by WHO 2008 revised classification, excluding Philadelphia chromosome-positive (Ph+) ALL (or BCR-ABL+) and B-cell ALL 3 Burkitt like, who have failed conventional or investigational therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 patients

Participant exclusion criteria

1. Major surgery within previous 4 weeks
2. Diagnosis of acute promyelocytic leukemia, Philadelphia chromosomepositive (Ph+) ALL (or BCR-ABL+) or B-cell ALL 3 Burkitt like
3. Patients who have not recovered from toxicity of previous antileukaemic therapy, including grade < or equal to 1 non-haematologic toxicity
4. Any previous chemotherapy for AML within at least 2 weeks (or at least 5 half-life whichever is longer), except for hydroxyureas which must be stopped within 24 hours before starting the study drug)
5. Neutrophil growth factor stimulating agent (G-CSF) within previous one week
6. Last dose of biological therapy or immunotherapy agent (therapeutic or diagnostic) less than 7 days prior to the first study drug intake
7. Any concurrent treatment with anticoagulants (curative or preventive),
8. Any radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
9. Patients with history of allogeneic stem cell transplant of less than 6 months or with active graft versus host disease requiring immune suppressive therapy
10. Patients with active disseminated intravascular coagulation (DIC) (plasma fibrinogen <1 g/L)
11. Presence of heart disorders or clinically significant heart diseases
12. Pregnant or breastfeeding women, women of child-bearing potential without effective contraception

Recruitment start date

15/07/2012

Recruitment end date

17/10/2014

Locations

Countries of recruitment

France

Trial participating centre

Institut Paoli Calmettes
Marseille CEDEX 9
13273
France

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

On 31/03/2015 the overall trial end date was changed from 30/12/2014 to 30/12/2015. On 17/12/2015 the following changes were made to the trial record: 1. Sponsoring/funding responsibility for the S 78454 project was transferred from Servier, France to Pharmacyclics, USA on 23/11/2014. 2. The overall trial end date was changed from 30/12/2015 to 30/09/2015.