A Phase I, Dose-escalation Study of AS703569 Given Orally to Subjects With Haematological Malignancies

PHASE1TerminatedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

March 31, 2010

Study Completion Date

August 31, 2011

Conditions
Haematological Malignancies
Interventions
DRUG

AS703569

"Dose Escalation~Regimen 1 - 3-47 mg/m2/day, orally once daily on days 1, 2,3 and 8, 9, 10 of a 21 day cycle:~Number of cycles: until progression or unacceptable toxicity develops.~Cohort Expansion~Regimen 1 - Maximum tolerated dose from dose-escalation part or a lower dose in mg/m2/day, orally once daily on days 1, 2,3 and 8, 9, 10 of a 21 day cycle:~Number of cycles: until progression or unacceptable toxicity develops"

DRUG

AS703569

"Dose Escalation Regimen 2 - 3-47 mg/m2/day, orally once daily on days 1, 2, 3, 4, 5, 6 of a 21 day cycle Number of cycles: until progression or unacceptable toxicity develops.~Cohort Expansion Regimen 2 - Maximum tolerated dose from dose-escalation part or a lower dose in mg/m2/day, orally once daily on days 1, 2, 3, 4, 5, 6 of a 21 day cycle Number of cycles: until progression or unacceptable toxicity develops."

Trial Locations (10)

1211

Hospitaux Universitaires, Geneva

3000

Haematologie UZ Gasthuisberg, Leuven

9007

Kantonsspital St Gallen, Sankt Gallen

40138

Policlinico Sant'Orsola Malpighi, Bologna

78229

CTRC at the UT Health Science Center at San Antonio, San Antonio

B-5530

Mont-Godinne University Hospital (UCL), Yvoir

D-60590

Universitatsklinik Frankfurt, Frankfurt am Main

D-81675

Technische Universitat Munchen, München

D-89070

Medizinische Universitatsklinik, Ulm

CH-4031

Kantonsspital Basel, Basel

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EMD Serono

INDUSTRY

NCT01080664 - A Phase I, Dose-escalation Study of AS703569 Given Orally to Subjects With Haematological Malignancies | Biotech Hunter | Biotech Hunter