WithdrawnPhase 1/2

Careseng 1370 for Chemotherapy-Induced Myelosuppression

Stopped: At sponsor's discretion

0Started 2019-03

Plain-language summary

This is a Phase I/IIa dose-finding (Phase I) followed by randomized, double-blind, placebo-controlled, parallel, add-on to cisplatin + docetaxel (Phase IIa) study to evaluate the safety, tolerability, and efficacy profiles of Careseng 1370 in subjects with advanced NSCLC.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Of either gender aged at least 20 years old
✓. Histologically or cytologically confirmed unresectable, locally advanced, metastatic untreated NSCLC and can be accurately assessed by computed tomography/magnetic resonance imaging (CT/MRI) scan (RECIST v1.1) for which regimen of cisplatin + docetaxel is arranged by the investigator; no prior chemotherapy treatment for this disease will be allowed.
✓. ECOG performance status score ≤2 and life expectancy ≥12 months
✓. Dated and signed informed consent

Exclusion criteria

✕. Had chemotherapy, therapeutic radiotherapy, or other therapy for NSCLC within 6 weeks before Screening visit
✕. Has undergone major surgery within 4 weeks before Screening visit
✕. With contraindications to MRI
✕. Has elective or planned surgery to be conducted during the trial
✕. Has documented brain or leptomeningeal metastases or any cancer other than NSCLC
✕. Inadequate hematologic function, as defined by: absolute neutrophil count (ANC) ≤ 1,500/µL; hemoglobin concentration \< 10.0 g/dL; and platelet count ≤ 100,000/µL
✕. Inadequate hepatic function, as defined by: total bilirubin level \> ULN; AST or ALT \> 1.5 x ULN; gamma-GT \> 2.5 x ULN; ALP \> 2.5 x ULN.
✕. Inadequate renal function, as defined by: serum creatinine level \> 1.5 x ULN; or calculated serum creatinine clearance (Cockcroft-Gault) \< 50 mL/min

What they're measuring

Maximum change of absolute neutrophil count (ANC) up to End of Treatment visit

Timeframe: Day 1, 8, 15 22, 29, 36, 43, 50, 57, 64, 71, 78, 85

Trial details

NCT IDNCT03692780

SponsorCareseng Biotech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03

View on ClinicalTrials.gov More Chemotherapy-Induced Myelosuppression trials