Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 12, 2019
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 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
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, 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 ClinicalTrials.gov identifier (NCT number): NCT02629692


Contacts
Layout table for location contacts
Contact: Head, Clinical development +9122 66455645 clinical.trials@sparcmail.com

  Show 33 Study Locations
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited

Layout table for additonal information
Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT02629692     History of Changes
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
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases