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

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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 )

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
We found this trial at
10
sites
Valhalla, New York 10595
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Antwerpen,
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Antwerpen,
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2387 Clements Ferry Road
Charleston, South Carolina 29425
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Charleston, SC
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Dallas, Texas
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Dallas, TX
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685 Venice Boulevard
Glendale, California 91204
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Glendale, CA
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Houston, Texas
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Houston, TX
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685 Venice Boulevard
Los Angeles, California 90033
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Los Angeles, CA
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New York, New York 10065
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New York, NY
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Salt Lake City, Utah
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Salt Lake City, UT
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Seattle, Washington 98109
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Seattle, WA
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