← Back to Search

Alkylating agents

Debio 0123 + Chemotherapy for Small Cell Lung Cancer

Phase 1

Recruiting

Research Sponsored by Debiopharm International SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumor that is not bleeding

ECOG performance status of 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately up to 44 months

Awards & highlights

Study Summary

This trial aims to test safety and tolerability of a new drug when combined with other drugs.

Who is the study for?

Adults with small cell lung cancer that's come back or gotten worse after platinum-based therapy can join. They need a confirmed diagnosis, have had prior chemo, be in fairly good health (ECOG 0-1), and expect to live at least 3 more months. They must have measurable disease and not be dealing with major infections like HIV/HBV/HCV, significant heart issues, or other active cancers.Check my eligibility

What is being tested?

The trial is testing Debio 0123 combined with carboplatin and etoposide in two parts: first to find the safest dose (RP2D) and then to see how well patients tolerate it. It's for those whose cancer returned or progressed after initial treatment.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system due to Debio 0123, as well as typical chemotherapy-related issues such as nausea, fatigue, blood count changes leading to increased infection risk, kidney or liver function problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My tumor is not bleeding.

Select...

I am fully active or can carry out light work.

Select...

My cancer is confirmed as small cell lung cancer through testing.

Select...

I have received platinum-based chemotherapy before.

Select...

I am willing to have a tumor biopsy or have an available archived sample.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately up to 44 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately up to 44 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately up to 44 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

Parts 1 and 2: Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Parts 1 and 2: Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, Electrocardiogram (ECG), and Echocardiogram Parameters

+1 more

Secondary outcome measures

Part 1: Apparent Clearance (CL/F) of Debio 0123

Part 1: Apparent Terminal Half-life (t1/2) of Debio 0123 and its Metabolite

Part 1: Apparent Volume of Distribution (Vd/F) of Debio 0123

+16 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose Expansion: Debio 0123 + Etoposide + CarboplatinExperimental Treatment3 Interventions

Participants will receive Debio 0123 RP2D determined in Part 1 of the study, orally along with etoposide IV infusion and carboplatin IV infusion in 21-day cycles until disease progression or death or end of study.

Group II: Part 1: Dose Escalation: Debio 0123 + Etoposide + CarboplatinExperimental Treatment3 Interventions

Participants will receive Debio 0123 escalating doses, orally along with etoposide IV infusion and carboplatin IV infusion in 21-day cycles until disease progression or death or end of study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Etoposide

2010

Completed Phase 3

~2440

Carboplatin

2014

Completed Phase 3

~6670

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Debiopharm International SALead Sponsor

50 Previous Clinical Trials

7,127 Total Patients Enrolled

Frequently Asked Questions

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

How many participants is the research team recruiting for this trial?

"Affirmative. According to the information posted on clinicaltrials.gov, recruitment for this medical trial is active and ongoing; it was first publicized on May 2nd 2023 with a most recent update made available September 27th 2023. Seven sites are participating in the study's enrollment of 54 patients."

Answered by AI

Is Part 1: Dose Escalation: Debio 0123 + Etoposide + Carboplatin a safe treatment protocol for patients?

"As this is an initial phase trial, the safety of Debio 0123 combined with Etoposide and Carboplatin has been rated a 1 due to limited evidence supporting both efficacy and security."

Answered by AI

How many locations are involved in conducting this research?

"Seven medical centres are partaking in this trial, including Hospital Clinico Universitario de Valencia in Valencia, Hospital Universitario Vall d'Hebron in Barcelona, and Hospital Universitario 12 de Octubre in Madrid. Additionally, 4 other locations are hosting the clinical study."

Answered by AI

Is this research endeavor actively looking for participants?

"Indeed. Clinicaltrials.gov lists this trial as actively recruiting, which began on May 2nd 2023 and was last updated on September 27th 2023. 54 people need to be recruited from 7 medical centres for the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy

2023. "Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05815160.