Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.
Trial record 1 of 1 for:    CLR_15_03
Previous Study | Return to List | Next Study

Safety, Tolerability, Pharmacokinetics and Activity of K0706

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02629692
Recruitment Status : Recruiting
First Posted : December 14, 2015
Last Update Posted : June 12, 2019
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Brief Summary:
Phase 1/2 study to determine safety, tolerability, pharmacokinetics and activity of K0706

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia (for Part B and C) Healthy (For Part A) Drug: K0706 Drug: Placebo Phase 1 Phase 2

Detailed Description:
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 )

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 303 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Part A: Single ascending dose Part B: Multiple ascending dose safety and tolerability study in subjects with CML or Ph + ALL Part C: Efficacy and safety study in subjects with CML or Ph+ ALL
Masking: None (Open Label)
Masking Description: Part A: 2 arms: Investigational agent arm and Placebo arm Part B and C: Single arm
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: K0706
Part B: Single arm,open-label,dose escalation - Ongoing (Initiated enrollment in April 2017) Part C: Open label (study is on-going, open for recruitment)
Drug: K0706
Oral administration

Placebo Comparator: Placebo
Part A of the study: Two arm,Placebo-Controlled,double blind - Completed on Nov 2016
Drug: K0706
Oral administration

Drug: Placebo
Part A only

Primary Outcome Measures :
  1. Part B: Maximum tolerated dose [ Time Frame: Dose limiting toxicity is to be observed during 4 week period ]
  2. Part C: Proportion of major cytogenetic response after the initiation of study treatment [ Time Frame: Day 28 ]
    The proportion of subjects who achieve complete cytogenetic response (No Ph+ cells), or partial cytogenetic response (1-35% Ph+ cells) after the initiation of study treatment

  3. Part C: Major hematologic response [ Time Frame: 6 weeks ]
    The proportion of subjects who achieve a complete hematologic response and/or no evidence of leukemia response after the initiation of treatment

  4. Treatment emergent adverse events [ Time Frame: 30 days after the administration of the last dose of investigational medicinal product/until disease progression ]

Secondary Outcome Measures :
  1. Part B and C: Tmax [ Time Frame: 24 hours post dose ]
  2. Part B and C: Maximum plasma concentration [ Time Frame: 24 hours post dose ]
  3. Part B and C: Area under the plasma concentration time curve (0-24 hours) [ Time Frame: 24 hours post dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02629692

Layout table for location contacts
Contact: Head, Clinical development +9122 66455645

Hide Hide 33 study locations
Layout table for location information
United States, California
SPARC Site 19 Recruiting
Glendale, California, United States, 91204
SPARC Site 20 Withdrawn
Los Angeles, California, United States, 90033
United States, New York
SPARC Site 31 Recruiting
New York, New York, United States, 10065
SPARC Site 23 Recruiting
Valhalla, New York, United States, 10595
United States, South Carolina
SPARC Site 22 Withdrawn
Charleston, South Carolina, United States, 29425
United States, Texas
SPARC Site 24 Recruiting
Dallas, Texas, United States, 75246
SPARC Site 21 Recruiting
Houston, Texas, United States, 77030
United States, Utah
SPARC Site 33 Recruiting
Salt Lake City, Utah, United States, 84132
United States, Washington
SPARC Site 32 Recruiting
Seattle, Washington, United States, 98109
SPARC Site 2 Recruiting
Antwerpen, Belgium
SPARC Site 1 Recruiting
Leuven, Belgium
SPARC Site 3 Withdrawn
Praha 10, Czechia
SPARC Site 4 Recruiting
Marseille Cedex 9, France
SPARC Site 8 Withdrawn
Nice, France
SPARC Site 7 Recruiting
Pierre-Bénite, France
Contact: Thomas Xavier         
SPARC Site 6 Withdrawn
Toulouse Cedex 9, France
SPARC Site 5 Recruiting
Tours Cedex 9, France
SPARC Site 28 Recruiting
Nashik, Maharashtra, India, 422004
SPARC Site 26 Recruiting
Pune, Maharashtra, India, 411004
SPARC Site 27 Recruiting
Kolkata, West Bengal, India, 700026
SPARC Site 12 Withdrawn
Hyderabad, India
SPARC Site 9 Withdrawn
Jaipur, India
SPARC Site 11 Recruiting
Kolkata, India
SPARC Site 14 Recruiting
Madurai, India
SPARC Site 10 Recruiting
Mumbai, India
SPARC Site 15 Recruiting
Mumbai, India
SPARC Site 13 Withdrawn
Surat, India
SPARC Site 29 Recruiting
Monza, Milano, Italy, 20900
SPARC Site 16 Recruiting
Meldola, Italy
SPARC Site 17 Recruiting
Milano, Italy
Korea, Republic of
SPARC Site 25 Recruiting
Seoul, Korea, Republic of, 06591
United Kingdom
SPARC Site 30 Recruiting
London, Greater London, United Kingdom, W120HS
SPARC Site 18 Recruiting
London, United Kingdom
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited

Layout table for additonal information
Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT02629692    
Other Study ID Numbers: CLR_15_03 V 11 amendment 11
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases