To determine safety,tolerability and activity of K0706 in subjects with chronic myeloid leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Phase 1
Active, not recruiting
- Conditions
- Chronic myeloid leukemia
- Registration Number
- CTRI/2017/03/008178
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
Part A: Recruitment is complete.
Part B: Closed to the recruitment of participants.
Part C: Not applicable (Part C of the study is not part ofthe India-specific protocol).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 304
Inclusion Criteria
- Willing and able to give written, and dated, informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study.
- Willing and able to comply with the scheduled visits.
- Male or female aged 18 to 65 years (both inclusive).
- Minimum life expectancy of at least 12 months in the Investigator’s opinion.
Exclusion Criteria
- Any major surgery.
- Blood transfusion within 4 weeks of IMP administration.
- Inability to swallow oral medication.
- Inability to undergo venipuncture and/or tolerate venous access.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose 28 days
- Secondary Outcome Measures
Name Time Method Cmax, AUC, Tmax 24 hours
Trial Locations
- Locations (5)
Meenakshi Mission Hospital and Research Centre
🇮🇳Madurai, TAMIL NADU, India
Prince Aly Khan Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Sahyadri Speciality Hospital
🇮🇳Pune, MAHARASHTRA, India
Tata Medical Center
🇮🇳Kolkata, WEST BENGAL, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Meenakshi Mission Hospital and Research Centre🇮🇳Madurai, TAMIL NADU, IndiaDr Krishna Kumar RathnamPrincipal investigatorkkrathnam@gmail.com