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Multi-Kinase Inhibitor

LNK01002 for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Research Sponsored by Lynk Pharmaceuticals Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 2, and day 15
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and tolerated in patients with myelofibrosis, polycythemia vera, essential thrombocythemia, or acute myeloid leukemia.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Primary Myelofibrosis
  • Polycythemia Vera
  • Myelofibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 2, and day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 2, and day 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessing maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms
Assessing the preliminary antitumor activity of LNK01002
Assessing the safety and tolerability of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms
Secondary outcome measures
Measurement of pharmacokinetic (PK) parameter, AUC, in MF, PV,PV-MF or ET-MF patients
Measurement of pharmacokinetic (PK) parameter, CL/F, in MF, PV, PV-MF or ET-MF patients
Measurement of pharmacokinetic (PK) parameter, Cmax, in MF, PV,PV-MF or ET-MF patients
+4 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: Patients with Primary or Secondary Myelofibrosis,PVExperimental Treatment1 Intervention
LNK01002 at the RP2D dose in 28-day treatment cycles
Group II: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 60 mgExperimental Treatment1 Intervention
LNK01002 60 mg BID, followed by a 3-day observation period then 60 mg BID in 28-day treatment cycles
Group III: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 30 mgExperimental Treatment1 Intervention
LNK01002 30 mg twice daily (BID), followed by a 3-day observation period then 30 mg BID in 28-day treatment cycles
Group IV: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 260 mgExperimental Treatment1 Intervention
LNK01002 260 mg BID, followed by a 3-day observation period then 260 mg BID in 28-day treatment cycles
Group V: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 200 mgExperimental Treatment1 Intervention
LNK01002 200 mg BID, followed by a 3-day observation period then 200 mg BID in 28-day treatment cycles
Group VI: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 150 mgExperimental Treatment1 Intervention
LNK01002 150 mg BID, followed by a 3-day observation period then 150 mg BID in 28-day treatment cycles
Group VII: Patients with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 100 mgExperimental Treatment1 Intervention
LNK01002 100 mg BID, followed by a 3-day observation period then 100 mg BID in 28-day treatment cycles
Group VIII: Patients with Malignant Myeloid Hematologic Neoplasms Without Mutant FLT3Experimental Treatment1 Intervention
LNK01002 at the RP2D dose in 28-day treatment cycles
Group IX: Patients with Acute Myeloid Leukemia With Mutant FLT3Experimental Treatment1 Intervention
LNK01002 at the RP2D dose in 28-day treatment cycles
Group X: Patient with Malignant Myeloid Hematologic Neoplasms treated with LNK01002 15 mgExperimental Treatment1 Intervention
Single dose of LNK01002 15 mg; followed by a 3-day observation period then 15mg BID in 28-day treatment cycles

Find a Location

Who is running the clinical trial?

Lynk Pharmaceuticals Co., LtdLead Sponsor
5 Previous Clinical Trials
1,267 Total Patients Enrolled
Sherry Weigand, M.D., Ph.D.Study DirectorLynk Pharmaceuticals Co., Ltd
Linda Wei, M.D.Study DirectorLynk Pharmaceuticals Co., Ltd

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research require additional participants at present?

"Affirmative. Clinicaltrials.gov records suggest that this clinical trial, which was initially publicised on April 8th 2021, is still open for enrolment. Approximately 93 patients are needed to be recruited from two separate sites/institutions."

Answered by AI

Are geriatric patients being enrolled into this inquiry?

"The requirements to be accepted into this trial specify that the patient must have an age of 18 or above and below 99. There are 451 studies for patients younger than 18, and 1333 trials targeting those over 65 years old."

Answered by AI

To what demographic does this clinical trial cater?

"This clinical trial is recruiting 93 individuals between the ages of 18 and 99 who are diagnosed with primary myelofibrosis. Furthermore, these patients must meet Intermediate or High-Risk PMF criteria, have symptomatic splenomegaly, not had a splenectomy in the past 6 months, and women of childbearing potential need to take a pregnancy test at screening. Additionally, any female patient capable of bearing children or male participants along with their partners must agree to use effective contraception during the study's duration and for six months after completion."

Answered by AI

Can you assess the potential adverse effects of LNK01002 treatment?

"The safety of LNK01002 was determined to be a 1 due to the Phase 1 status of this trial, which only provides limited data demonstrating efficacy and minimal evidence supporting its security."

Answered by AI

What are the ultimate goals of this experiment?

"Across the span of 31 days, this clinical trial will assess the preliminary anti-tumor efficacy of LNK01002. Additionally, it seeks to measure pharmacokinetic parameters like CL/F, MRT and Vz/F using extensive PK sampling in patients with myelofibrosis (MF), post-essential thrombocythemia MF (ET-MF) or polycythaemia vera associated MF (PV-MF)."

Answered by AI

How many participants are eligible to join this experimentation?

"Indeed, clinicaltrials.gov suggests that the trial is in progress and recruiting participants. Initially posted on 8th April 2021, it was last modified on 5th June 2021 with a recruitment goal of 93 patients from 2 locations."

Answered by AI
~0 spots leftby Apr 2025