CLR_15_03 Activity of K0706 Leukaemia
Research type
Research Study
Full title
A Two-Part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects with Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
IRAS ID
223671
Contact name
Jane Apperley
Contact email
Sponsor organisation
Sun Pharma Advanced Research Company (SPARC) Limited
Eudract number
2016-001754-18
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
127347, IND Number
Duration of Study in the UK
2 years, 6 months, 25 days
Research summary
This is a Phase I/II study in which it is proposed to determine safety and effectiveness of the study drug K0706, in healthy participants and in patients with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukaemia (Ph+ ALL).
This study has two parts:
Part A which is the phase I part of the study and is a multi-centre study conducted in the USA only, in healthy male subjects. Part A of the trial is currently ongoing.Part B of the trial which is a combination of a Phase 1 and a Phase 2 study and will be performed as a multi-national, multi-centre, open label, dose-escalation study in participants with Ph+ CML and Ph+ ALL. Part B will involve multiple doses per participant and will be used to determine the Maximum Tolerated Dose (MTD) and to help define the recommended Phase 2 dose (RP2D) appropriate for the two patient populations involved.
Part B of the trial will be conducted at approximately 27 centres globally.
The present application, and related documentation provided, refers to Part B of the trial only.
Participation in this study may last up to a total of 25 months, including up to 21 days for the screening period, 12 months (about 13 cycles) of treatment with the study drug, and 12 months of the follow up period after the last dose of the study drug. The participant may be in the study longer if the study doctor thinks they are benefiting from treatment and they will continue to receive the study drug beyond 12 cycles. The participant will take the study drug by mouth as oral capsules.
It is anticipated that approximately 110 patients will be enrolled in Part B.
The Sponsor (Sun Pharma Advanced Research Company [SPARC] Limited) has developed the study drug, K0706.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/1429
Date of REC Opinion
26 Dec 2017
REC opinion
Further Information Favourable Opinion