Vodobatinib for Chronic Myeloid Leukemia

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Sun Pharma Advanced Research Company Limited

No Placebo Group

Trial Summary

What is the purpose of this trial?Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML

Eligibility Criteria

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.

Inclusion Criteria

I can take care of myself and perform daily activities.

I have CML and my condition didn't improve after 3 different treatments, including ponatinib.

Exclusion Criteria

My cancer has the T315I mutation.

I haven't had any cancer other than non-melanoma skin or cervical cancer in situ in the past 3 years.

Treatment Details

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).

1Treatment groups

Experimental Treatment

Group I: Vodobatinib (K0706) capsulesExperimental Treatment1 Intervention