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

NCT03891173 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-08-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

L-DOS47

L-DOS47 lyophilized powder reconstituted and diluted for iv injection

DRUG

Cisplatin

Cisplatin concentrate for solution for iv infusion

DRUG

Vinorelbine

Vinorelbine concentrate for solution for iv infusion

Sponsors & Collaborators

  • KCR S.A.

    collaborator UNKNOWN

  • Helix BioPharma Corporation

    lead INDUSTRY

Principal Investigators

  • Cezary Szczylik, MD, Ph.D. · Europejskie Centrum Zdrowia Otwock

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2020-05-22
Completion
2020-05-22
FDA Drug
Yes

Countries

  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03891173 on ClinicalTrials.gov