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Status:

COMPLETED

HL-085 in NRAS-mutated Advanced Melanoma

Lead Sponsor:

Shanghai Kechow Pharma, Inc.

Conditions:

Melanoma

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief Summary

This was an open-label, single-arm, multi-center phase II clinical study, aimed at investigating the efficacy and safety of HL-085 capsule in the treatment of advanced melanoma patients with NRAS muta...

Detailed Description

This was an open-label, single-arm, multi-center phase II clinical study, aimed at investigating the efficacy and safety of HL-085 capsule in the treatment of advanced melanoma patients with NRAS muta...

Eligibility Criteria

Inclusion

  • Aged 18 Years or older (male or female).
  • Patients have histologically or cytologically confirmed Unresectable stage III or IV melanoma;
  • Able to provide the genetic test report with documented NRAS mutation at baseline.
  • At least one target lesion as per RECIST v1.1 criteria.
  • Previous chemotherapy, immunotherapy, or radiotherapy must have been completed at least 4 weeks prior to study drug administration, and all related toxic reactions (with the exception of alopecia) must have been resolved (to Grade ≤1 or baseline) prior to study drug administration.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy \> 3 months.
  • No major surgery (excluding baseline tumor biopsy) or major trauma occurred at least 14 days prior to study drug administration.

Exclusion

  • Patients with active central nervous system (CNS) lesions (i.e., radiological evidence of instability, symptomatic lesions) should be excluded. Note: Patients receiving stereotactic brain radiotherapy or surgery who have shown no brain disease progression over a period of 3 months or longer are eligible for inclusion.
  • Patients had received any other study treatment within the past 4 weeks prior to study drug administration.
  • Inability to swallow the capsule, refractory nausea and vomiting, malabsorption, extracorporeal biliary shunt, or any small intestinal resection that would preclude adequate absorption of the study drug.
  • ECG QTcB ≥ 480 msec (adjusted by Bazetts formula) during screening, or a history of congenital long QT syndrome.
  • Bleeding symptoms of Grade 3 as defined by the National Cancer Institute General Terminology Standard for Adverse Events (NCI CTCAE V5.0) within the past 4 weeks prior to study initiation.
  • One of the following situations occurs within the past 6 months prior to administration of study drug: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass grafting, symptomatic congestive heart failure, serious arrhythmia, uncontrolled hypertension, cerebrovascular accident, or transient ischemic attack, or symptomatic pulmonary embolism.
  • Current use of other anti-cancer drugs (hormone therapy was acceptable).
  • Uncontrolled concomitant diseases or infectious diseases.
  • Patients have retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED) or other retinal diseases previously or currently.

Key Trial Info

Start Date :

November 2 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 20 2023

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT05217303

Start Date

November 2 2020

End Date

February 20 2023

Last Update

May 31 2023

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

2

Beijing Oncology Hospital

Beijing, Beijing Municipality, China