Safety, Tolerability, Pharmacokinetics and Activity of K0706

• ClinicalTrials.gov Identifier: NCT02629692
• Recruitment Status: Recruiting
• First Posted: December 14, 2015
• Last Update Posted: June 12, 2019
• Sponsor: Sun Pharma Advanced Research Company Limited
• Information provided by (Responsible Party): Sun Pharma Advanced Research Company Limited

Study Description

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 )

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

  Show 33 Study Locations

Sponsors and Collaborators

Sun Pharma Advanced Research Company Limited

More 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
• Last Update Posted: June 12, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases