XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-… (NCT04622072) | Clinical Trial Compass
TerminatedPhase 1
XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
Stopped: Strategic considerations
China21 participantsStarted 2020-11-02
Plain-language summary
The trial is divided into two parts, one is dose escalation phase, the second one is dose expansion phase.
For dose escalation phase, the main purpose is to evaluate safety and tolerability of XZP-5809-TT1 tablets after treatment with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) in patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer, and to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
For dose expansion phase, the main purpose is to evaluate Objective response rate (ORR) in patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer.
Who can participate
Age range18 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.
Exclusion criteria
✕. First medication (first medication refers to the first use of the test drug, hereinafter referred to as the first medication) patient use within 6 weeks Have used nitrosoureas or mitomycin C, or have used other cytotoxic chemotherapeutics or their drugs within 3 weeks before the first administration His anti-cancer drugs;
✕. The time from receiving any EGRF-TKI treatment to the first dose does not exceed the 5 half-life of the drug (for example, Elotinib is not more than 8 days, gefitinib is not more than 10 days, icotinib is not more than 2 days, and afatinib is not more than 8 days day);
✕. The time from receiving other experimental drugs or analogues to the first dose does not exceed the drug's 5 half-life or 14 days (whichever Senior citizens);
✕. The time from receiving other immune preparations to the first administration does not exceed 28 days;
✕. Major surgery (excluding vascular access establishment surgery and biopsy surgery) within 4 weeks before the first medication;
✕. The patient has received more than 30% bone marrow radiotherapy or large-area irradiation (excluding bone transfer) within 4 weeks before the first medication.
✕. In the resting state, the average corrected QT interval (QTc) obtained from ECG examination, QTc interval\>470 msec (QTcF=QT/RR1/3, when an abnormality is found in the first inspection, repeat the test twice within 48 hours, with an average of 3 times result calculation);
What they're measuring
1
adverse event
Timeframe: through study completion, an average of 1.5 year
2
Objective response rate (ORR)
Timeframe: through study completion, an average of 1.5 year
3
Progression-free survival (PFS)
Timeframe: through study completion, an average of 1.5 year
4
blood routine
Timeframe: through study completion, an average of 1.5 year
5
blood routine
Timeframe: through study completion, an average of 1.5 year
6
blood routine
Timeframe: through study completion, an average of 1.5 year