APG-1252 in Patients With SCLC or Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03387332|
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer and Other Solid Tumors||Drug: APG-1252||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Intravenously Administered APG-1252 in Patients With Small Cell Lung Cancer (SCLC) or Advanced Solid Tumors.|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||December 28, 2019|
|Estimated Study Completion Date :||December 28, 2019|
The starting dose for this study was 40 mg and 1 patient would be enrolled at this dose level. The dose escalation will convert to a standard 3+3 design following the occurrence of DLT or two ≥ Grade 2 adverse event or at doses 80 mg.
Multiple dose cohorts, 30 minute IV infusion, twice weekly for 3 weeks of a cycle with 28 days.
Other Name: APG-1252 for injection
- Dose limit toxicity (DLT) determination [ Time Frame: 18-24 months ]Number of participants with APG-1252 treatment-related adverse events as assessed by CTCAE v4.03
- Maximum tolerated dose (MTD) determination [ Time Frame: 18-24 months ]If ≥ 2/6 patients develop a DLT at any dose level, then this dose will be declared as the MTD.
- Pharmacokinetic evaluation [ Time Frame: 18-24 months ]Peak plasma concentration (Cmax) will be assessed on all participants with APG-1252 treatments.
- Preliminary efficacy assessment [ Time Frame: 18-24 months ]Patients will be evaluated for response every 2 cycles (i.e., 8 weeks), according to the new response evaluation criteria in solid tumors: revised RECIST Guideline, Version 1.1
- Pharmacokinetic evaluation [ Time Frame: 18-24 months ]Area under the plasma concentration versus time curve (AUC) will be assessed on all participants with APG-1252 treatments
- Pharmacodynamic evaluation [ Time Frame: 18-24 months ]Apoptosis will be assessed on the patients treated with APG-1252
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387332
|Contact: Yilong Wu, Professor||8620 firstname.lastname@example.org|
|Guangdong General Hospital||Recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Yilong Wu, Professor 8620 83827812 email@example.com|
|Study Director:||Yifan Zhai, M.D., Ph.D.||Ascentage (Suzhou) Pharma Group Inc|