A Phase 1 interventional study of HMPL-306 in Acute Myeloid Leukemia, sponsored by Hutchison Medipharma Limited. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-16.
Sponsored by Hutchison Medipharma Limited · Phase 1, Interventional, and Treatment
Phase I, multicenter study to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of HMPL-306 in Patients of Relapsed/Refractory Myeloid Leukemia/Neoplasms with IDH1 and/or IDH2 Mutation.
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of HMPL-306 in Patients of Relapsed/Refractory Myeloid Leukemia/Neoplasms with IDH1 and/or IDH2 Mutation. The first stage of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of HMPL-306 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second stage of the study is a dose expansion phase where three cohorts of patients will receive HMPL-306 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 75 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Hutchison Medipharma Limited is the lead sponsor of 66 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HMPL-306 administered continuously as a single agent orally every day in a 28-day cycle.
Drug: HMPL-306
HMPL-306 administered continuously as a single agent starting at 25 mg orally every day in a 28-day cycle and dose escalation is planned up to 200mg. Subjects may continue treatment with HMPL-306 until disease progression, development of other unacceptable toxicity or hematopoietic stem cell transplant.
Safety and tolerability: Incidence of adverse events
Incidence of adverse events.
Time frame: Baseline up to the last patient has completed the 24 weeks of treatment
Maximum tolerated dosage (MTD) and/or recommended phase 2 dosage (RP2D)
Measured by adverse event profile.
Time frame: Baseline up to the last patient has completed the 24 weeks of treatment
Cmax (Cycle 1 Day 1) of HMPL-306
Cmax: maximum observed drug concentration in measured matrix after single dose administration.
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start
AUC(0-24) (Cycle 1 Day 1) of HMPL-306
AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose.
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start
AUC(0-tlast) (Cycle 1 Day 1) of HMPL-306
AUC from time zero to the last data point.
Time frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start
Objective Response Rate (ORR)
proportion of patients with confirmed complete response (CR) and partial response (PR).
Time frame: Baseline up to the last patient has completed the 24 weeks of treatment
Duration of response (DOR)
DOR is defined as the time from the date of first observed tumor response (Complete response (CR) or Partial response (PR)) until first subsequent disease progression or until death (if death occurs before progression is documented) due to any cause.
Time frame: Baseline up to the last patient has completed the 24 weeks of treatment
Progression-free survival (PFS)
PFS is defined as the time from enrollment (i.e., date of treatment assignment) to disease progression.
Time frame: Baseline up to the last patient has completed the 24 weeks of treatment
Overall survival (OS)
OS is defined as the time from enrollment (i.e., date of treatment assignment) until death from any cause or until the last date the patient is known to be alive.
Time frame: Baseline up to the last patient has completed the 24 weeks of treatment
Plan to share: No
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This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Hutchison Medipharma Limited