A Study of L-DOS47 in Combination With Vinorelbine/Cisplatin in Lung Adenocarcinoma

Sponsor
Helix BioPharma Corporation
Study ID
NCT03891173
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • L-DOS47 — DRUG
    L-DOS47 lyophilized powder reconstituted and diluted for iv injection
  • Cisplatin — DRUG
    Cisplatin concentrate for solution for iv infusion
  • Vinorelbine — DRUG
    Vinorelbine concentrate for solution for iv infusion

Study Details

This study will determine the highest dose of L-DOS47 that can be given in combination with vinorelbine/cisplatin, evaluate safety and tolerability of L-DOS47 when given in combination with vinorelbine/cisplatin, and assess how effective this combination is in treating patients with lung adenocarcinoma compared to patients who are given vinorelbine/cisplatin alone.

Key Dates

Start date
Feb 19, 2019
Status verified
Aug 2022
Primary completion
May 22, 2020
Completion
May 22, 2020

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: L-DOS47 in combination with cisplatin + vinorelbine
    L-DOS47 (6/9/12 µg/kg) is administered by iv on Day 1 and 8 of each 21-day treatment cycle, in combination with iv administration of standard cisplatin (80 mg/m2) on Day 2 + vinorelbine (30 mg/m2) on Day 2 and 9.
  • Active Comparator: Cisplatin + vinorelbine alone
    Administration by iv of standard Cisplatin (80 mg/m2) on Day 1 + vinorelbine (30 mg/m2) on Day 1 and 8 of each 21-day treatment cycle.

Primary Outcome Measure

Time to disease progression [ Time Frame: Up to 12 weeks ]

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