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Trial Summary

This is a multi-center, open-label, phase Ib/II study of combination therapy with APG-1252 plus paclitaxel in patients with relapsed/refractory small-cell lung cancer(SCLC). The phase Ib portion will be done using time-to-event continual reassessment method (TITE-CRM) methodology to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of APG-1252 with a fixed dose of paclitaxel. The phase II portion will utilize a Simon two-stage design to determine the efficacy of the combination therapy with response rate as the primary endpoint.

Acronym:

APG SCLC

ACTRN/NCT /ethics:

NCT04210037

Scientific title:

A Multi-Center, Phase Ib/II Study of Combination Treatment of APG-1252 With Paclitaxel in Patients With Relapsed/Refractory Small Cell Lung Cancer

Sponsor / Cooperative group:

Ascentage Pharma Group Inc

Trial & Patient Characteristics

Cancer TypeMelanoma & other skin, Other
Trial TypeTreatment
PhasePhase I, Phase II
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageLocally Advanced,
Anticipated Start Date2020-08-20
Anticipated End Date2021-08-30

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorHannah Adelson
EmailHannah.adelson@sa.gov.au
Phone08 8206 4835
Principal InvestigatorProfessor Chris Karapetis
Recruitment StatusRecruitment on Hold