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Tyrosine Kinase Inhibitor
Vodobatinib for Chronic Myeloid Leukemia
Phase 1 & 2
Waitlist Available
Research Sponsored by Sun Pharma Advanced Research Company Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, who are resistant and/or intolerant to ≥ 3 prior TKIs one of which includes ponatinib (Part C).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all subjects will be followed up for 60 months from the first dose of vodobatinib (k0706)
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and works well against leukemia.
Who is the study for?
This trial is for adults over 18 with chronic myelogenous leukemia (CML) who haven't responded to at least three prior treatments, including ponatinib. They should be in a condition where they can perform daily activities with ease or have some limitation (ECOG status of 0-2). People ineligible include those unable to undergo blood draws, recent major surgery patients, candidates for curative therapy like stem cell transplant, other cancer diagnoses within 3 years, drug abuse history, T315I mutation presence in CML (Part C), and positive tests for pregnancy or certain infections.Check my eligibility
What is being tested?
The study is testing Vodobatinib capsules' safety and effectiveness against resistant/intolerant chronic myelogenous leukemia. It's a Phase 1/2 trial which means it's early in the clinical research process focusing on how safe the treatment is (Phase 1) and starting to look at how well it works (Phase 2).See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with similar medications may include nausea, vomiting, diarrhea, muscle cramps or pain; changes in liver function tests; rash; headaches; fatigue; and fluid retention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
Select...
I have CML and my condition didn't improve after 3 different treatments, including ponatinib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all subjects will be followed up for 60 months from the first dose of vodobatinib (k0706)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all subjects will be followed up for 60 months from the first dose of vodobatinib (k0706)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
For CML subjects in AP at study entry
For CML subjects in BP at study entry
For CML subjects in CP at study entry
+2 moreSecondary outcome measures
In all subjects Overall survival (OS)
In all subjects Progression free survival (PFS)
In subjects with CML- CP:Proportion of subjects achieving Complete Cytogenetic Response as assessed by conventional Karyotyping of Bone marrow aspirate
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Vodobatinib (K0706) capsulesExperimental Treatment1 Intervention
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Who is running the clinical trial?
Sun Pharma Advanced Research Company LimitedLead Sponsor
32 Previous Clinical Trials
4,465 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and perform daily activities.You have a history of serious drug abuse according to the investigator's assessment.I am eligible for a treatment that could potentially cure my condition, including a stem cell transplant.My cancer has the T315I mutation.You have taken any experimental medication within the last 30 days or longer if needed for the medication to fully leave your system.I am 18 years old or older.I have CML and my condition didn't improve after 3 different treatments, including ponatinib.I haven't had any cancer other than non-melanoma skin or cervical cancer in situ in the past 3 years.You are unable to have blood drawn or have difficulty with IV access.I have not had any major surgery within the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Vodobatinib (K0706) capsules
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for study participants in this clinical trial?
"Per the details on clinicaltrials.gov, this research is still recruiting participants. The trial was first announced in April 25th 2017 and had its last update recorded recently on April 27th 2022."
Answered by AI
How many participants are enrolled in this clinical experimentation?
"The medical trial necessitates 303 participants to be recruited, assuming they meet the set inclusions criteria. Those interested can apply from two different locations: IU Simon Cancer Center of Indianapolis, Indiana or The Oncology Institute of Hope and Innovation within Innovative Clinical Research Institute of Downey, California."
Answered by AI
What pre-established goals is this clinical experiment attempting to accomplish?
"This medical experiment's primary purpose is to evaluate the intensity and prevalence of dose limiting toxicities experienced over a 4-week period by measuring Treatment Emergent Adverse Events (TEAEs) with CTCAE v4.03. Additionally, Time to Major Cytogenetic Response (MCyR), Incidence and severity of TEAEs as assessed by CTCAE v5.0, and Overall Survival will be measured for all subjects enrolled in this trial."
Answered by AI
What is the geographic reach of this clinical trial's administration?
"This clinical study is recruiting participants at IU Simon Cancer Center in Indianapolis, Indiana; The Oncology Institute of Hope and Innovation, Innovative Clinical Research Institute in Downey, California; Hackensack University Medical Center in Hackensack, New jersey and 12 other medical centres."
Answered by AI
Who else is applying?
What state do they live in?
Utah
California
Texas
How old are they?
18 - 65
What site did they apply to?
UCLA Hematologic Malignancy Program
Huntsman Cancer Institute University of Utah
Baylor University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
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