To determine safety,tolerability and activity of K0706 in subjects with chronic myeloid leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

A Phase 1 study to determine safety, tolerability, pharmacokinetics, and activity of K0706, a novel tyrosine kinase inhibitor (TKI) in subjects with Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/03/008178

Enrollment

304

Registered

2017-03-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic myeloid leukemia

Interventions

Intervention1: K0706 capsules: dose escalation study Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: - Willing and able to give written, and dated, informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study - Willing and able to comply with the scheduled visits - Male or female aged 18 to 65 years (both inclusive) - Minimum life expectancy of at least 12 months in the Investigator’s opinion

Exclusion criteria

Exclusion criteria: - Any major surgery - Blood transfusion within 4 weeks of IMP administration - Inability to swallow oral medication - Inability to undergo venipuncture and/or tolerate venous access

Design outcomes

Primary

Measure	Time frame
Maximum tolerated doseTimepoint: 28 days	—

Secondary

Measure	Time frame
Cmax, AUC, TmaxTimepoint: 24 hours	—

Countries

India

Contacts

Public ContactDr Sandeep Inamdar

Sun Pharma Advanced Research Company Limited

Clinical.Trials@sparcmail.com91-22-66455645

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026