The MYC oncogene - the grand orchestrator of cancer growth and immune evasion.
Renumathy Dhanasekaran, Anja Deutzmann, Wadie D Mahauad-Fernandez...
https://pubmed.ncbi.nlm.nih.gov/34508258/Actively Recruiting
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2025-12-05
15
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are evaluating the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer ES-SCLC who have high expression of the c-Myc-driven FBXW2MYC gene and have not responded to standard treatments. This phase II clinical study aims to explore how the expression of FBXW2MYC correlates with the treatment effects of teniposide in this patient group. Participants will receive teniposide administered intravenously at a dose of 60 mgm2, diluted in 500 ml of 0.9% sodium chloride, infused over more than one hour daily for 3 to 5 consecutive days. One treatment cycle lasts 21 days. Imaging evaluations will be performed at the start and then every 6 to 8 weeks during treatment, with an average study duration of one year. During the study, researchers will monitor the objective response rate through imaging, as well as disease control rate, progression-free survival, and duration of response. Safety monitoring includes tracking adverse and serious adverse events from baseline until 30 days after the last dose. Participants can expect regular assessments and imaging scans throughout their involvement, which may last about one year.
CONDITIONS
Post-line Treatment With Teniposide for c-Myc-driven Extensive-stage Small Cell Lung Cancer
J
jiale Wang
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Shanghai Pulmonary Hospital, Shanghai, China
Lead Sponsor
CHINA RESOURCES DOUBLE-CRANE PHARMACEUTICAL CO.,LTD
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive Teniposide through intravenous infusion for 3 to 5 consecutive days per cycle, with each cycle lasting 21 days.
Baseline and imaging visits every 6 to 8 weeks during treatment
Duration - Up to 30 days after last dose
Participants are monitored for adverse events up to 30 days after the last dose of Teniposide.
Regular safety monitoring visits
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Lead Sponsor
CHINA RESOURCES DOUBLE-CRANE PHARMACEUTICAL CO.,LTD
Collaborating Sponsor