Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lu… (NCT05815160) | Clinical Trial Compass
TerminatedPhase 1
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
Stopped: The trial was concluded for strategic reasons.
United States, Spain34 participantsStarted 2023-05-02
Plain-language summary
The primary purpose of part 1 (dose escalation) of this study is to identify the recommended dose and to characterize the safety and tolerability of Debio 0123 in combination with carboplatin and etoposide.
The primary purpose of part 2 (dose expansion) of this study is to characterize the safety and tolerability of Debio 0123 at the recommended dose when administered in combination with carboplatin and etoposide.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed SCLC
✓. Willingness and ability to undergo tumor biopsy unless an archived tumor sample is available
✓. ECOG performance status of 0-1
✓. Life expectancy of at least 3 months in the best judgment of the Investigator
✓. Adequate bone marrow, hepatic and renal function, adequate coagulation status
Exclusion criteria
✕. Use of an investigational agent or medical device within 28 days prior to first dose of study treatment.
✕. History of other malignancies requiring active treatment in the last 2 years prior to first dose of study treatment, except for superficial bladder cancers, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated with curative intent.
What they're measuring
1
Part 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Timeframe: Cycle 1 (Cycle=21 days)
2
Parts 1 and 2: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE)
Timeframe: Approximately up to 44 months
3
Parts 1 and 2: Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, Electrocardiogram (ECG), and Echocardiogram Parameters
Timeframe: Approximately up to 44 months
4
Parts 1 and 2: Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
✕. History of myocardial infarction or stroke in the last 6 months prior to first dose of study treatment, congestive heart failure greater than New York Heart Association (NYHA) class II, unstable angina pectoris, unexplained recurrent syncope, cardiac arrhythmia requiring treatment, known family history of sudden death from cardiac-related causes before the age of 50, or any cardiotoxicity experienced after previous chemotherapy.
✕. Left ventricular ejection fraction (LVEF) below 55%.
✕. QTcF \>450 ms, history of congenital long QT syndrome, or clinically significant conduction abnormality, or any conduction abnormality that may increase the risk of TdP.
✕. Clinically significant gastrointestinal abnormality that could affect the absorption of orally administered drugs
✕. Major surgery ≤4 weeks prior to first dose of study treatment or incomplete recovery from the surgical procedure at the time of the first dose of study treatment.
✕. Radiographic findings showing tumor involvement with large blood vessels or poor demarcation from them with increased risk for bleeding.