Safety, Tolerability, Pharmacokinetics and Activity of K0706
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/16/2019 |
Start Date: | April 25, 2017 |
End Date: | September 2021 |
Contact: | Sun Pharma Advanced Research Company Limited |
Email: | clinical.trials@sparcmail.com |
Phone: | +9122 66455645 |
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)
Phase 1/2 study to determine safety, tolerability, pharmacokinetics and activity of K0706
Part A ( for Healthy volunteers) of the study is completed Part B (for CML subject ) of the
study is ongoing. (Recruitment for Part B initiated in April 2017) Part C of study in
subjects with CML and Ph+ ALL is on-going. (Open for Recruitment )
study is ongoing. (Recruitment for Part B initiated in April 2017) Part C of study in
subjects with CML and Ph+ ALL is on-going. (Open for Recruitment )
Inclusion Criteria:
- Willing and able to give written, and dated, informed consent
- Male or female aged ≥ 18 years
- Willing and able to comply with the scheduled visits
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, or Ph+ ALL
Exclusion Criteria:
- Any major surgery, as determined by the Investigator, within 4 weeks of IMP
administration
- Inability to undergo venipuncture and/or tolerate venous access
- Positive exclusion tests: urine pregnancy tests (if applicable), HIV, hepatitis B
surface antigen, or hepatitis C virus
- Known or suspected history of significant drug abuse as judged by the Investigator
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