MedTrace Logo

Milciclib in Combination With Gemcitabine in Advanced NSCLC

NCT05651269 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-12-15

No results posted yet for this study

Summary

The goal of this interventional clinical study is to evaluate the safety and efficacy of Milciclib plus gemcitabine in the treatment of persons with advanced NSCLC. This is an open label uncontrolled clinical trial

Eligible patients will receive 150 mg/day of milciclib orally using the 7 days on/7 days off schedule in combination with gemcitabine at the dose of 1000 mg/m² on Days 1, 8, and 15 every 4 weeks. Treatment cycles will be repeated every 4 weeks until progressive disease (radiologic or symptomatic deterioration), the start of a new systemic anticancer therapy, unacceptable toxicity, withdrawal per investigator's judgment, or withdrawal of consent, whichever occurs first.

Conditions

Interventions

DRUG

Milciclib Dose: 150 mg/day Mode of administration: oral

milciclib plus gemcitabine

Sponsors & Collaborators

  • Tiziana Life Sciences LTD

    lead INDUSTRY

Principal Investigators

  • Matthew Davis, MD · Tiziana Life Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2024-12-31
Completion
2025-06-30
FDA Drug
Yes

More Related Trials

Entities

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 NCT05651269 on ClinicalTrials.gov