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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.
 
ClinicalTrials.gov Identifier: NCT02629692
Recruitment Status : Recruiting
First Posted : December 14, 2015
Last Update Posted : June 1, 2020
Sponsor:
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 capsules 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 only in India, other countries completed. (Recruitment for Part B initiated in April 2017)

Part C of study in subjects with CML is on-going in all mentioned countries except India. (Open for Recruitment )

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 303 participants
Allocation: N/A
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 : August 2022
Estimated Study Completion Date : August 2026


Arm Intervention/treatment
Experimental: K0706 capsules Drug: K0706 capsules

Part A: K0706 capsules in multiple ascending doses, once daily, oral

Part B: K0706 capsules in multiple ascending doses mg once daily, oral

Part C: K0706 capsules 174 mg , once daily, oral





Primary Outcome Measures :
  1. To determine the Maximum Tolerated Dose (MTD) as determined by frequency of Dose Limiting Toxicities [ Time Frame: Dose Limiting toxicities observed over a 4 week period ]
    PART B

  2. Incidence and severity of treatment emergent AEs as assessed by CTCAE v4.03 [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    PART B

  3. For CML subjects in CP at study entry [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    Proportion of subjects achieving Major Cytogenetic Response [ defined as complete cytogenetic response (CCyR; 0% Ph+metaphases) or partial cytogenetic response (PCyR; 1-35% Ph+ metaphases)] as assessed by conventional Karyotyping of Bone marrow aspirate

  4. For CML subjects in AP at study entry [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    Proportion of subjects achieving Major Hematologic Response [ defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample

  5. For CML subjects in BP at study entry [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    Proportion of subjects achieving Major Hematologic Response [defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample


Secondary Outcome Measures :
  1. Pharmacokinetic profile of K0706 - Cmax [The maximum (peak) observed drug concentration after dose administration] [ Time Frame: All subjects will be followed for up to approximately 60 months after the first dose of K0706 ]
    PART B

  2. Pharmacokinetic profile of K0706 - Tmax [The time to reach maximum (peak) drug concentration after dose administration] [ Time Frame: All subjects will be followed for up to approximately 60 months after the first dose of K0706 ]
    PART B

  3. Pharmacokinetic profile of K0706 - Cmin [ Minimum observed drug concentration after dose administration] [ Time Frame: All subjects will be followed for up to approximately 60 months after the first dose of K0706 ]
    PART B

  4. Incidence and severity of treatment emergent AEs as assessed by CTCAE v5.0 [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    PART C

  5. In subjects with CML- CP:Proportion of subjects achieving Complete Hematological Response as assessed by complete blood count of peripheral blood sample [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    PART C

  6. In subjects with CML- CP:Proportion of subjects achieving Complete Cytogenetic Response as assessed by conventional Karyotyping of Bone marrow aspirate [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    PART C

  7. In subjects with CML- CP:Proportion of subjects achieving Major Molecular Response as assessed by BCR-ABL transcript levels (BCR-ABL1 ratio of ≤ 0.01%) in peripheral blood using PCR (Polymerase Chain Reaction) [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    PART C

  8. In subjects with CML-AP & BP: Proportion of subjects achieving Major Cytogenetic Response (MCyR) as assessed by conventional Karyotyping of Bone marrow aspirate [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    PART C

  9. In subjects with CML-AP & BP: Proportion of subjects achieving Major Molecular Response as assessed by BCR-ABL transcript levels (BCR-ABL1 ratio of ≤ 0.01%) in peripheral blood using PCR (Polymerase Chain Reaction) [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    PART C

  10. Time to Major Cytogenetic Response (MCyR): Time to MCyR is the time from first dose to first MCyR (0-35% Ph+ metaphases) ; computed only for subjects who achieved MCyR [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    PART C

  11. Time to Major Molecular Response : Time to MMR is the time from first dose to first MMR (BCR-ABL1 ratio of ≤ 0.01%) computed only for subjects who achieved MMR [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    PART C

  12. Pharmacokinetic profile of K0706 - Cmax [The maximum (peak) observed drug concentration after dose administration] [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    PART C

  13. Pharmacokinetic profile of K0706 - Tmax [The time to reach maximum (peak) drug concentration after dose administration] [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    PART C

  14. Pharmacokinetic profile of K0706 - Cmin [ Minimum observed drug concentration after dose administration] [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    PART C



Information from the National Library of Medicine

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02629692


Contacts
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Contact: Head, Clinical development +9122 66455645 clinical.trials@sparcmail.com

Locations
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Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT02629692    
Other Study ID Numbers: CLR_15_03 V 12 amendment 12
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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