A Dose Finding and Expansion Study of RO7051790 Administered Orally in Participants With Relapsed, Extensive-Stage Disease Small Cell Lung Cancer (ED SCLC)

Official Title

A Multi-Centre, Open Label, Phase I, Dose Finding and Expansion Study of RO7051790 Administered Orally in Patients With Relapsed, Extensive-Stage Disease Small Cell Lung Cancer (ED SCLC)

Summary:

This is a Phase I, open-label, multicentre study designed to assess the safety and tolerability of RO7051790 in participants with relapsed ED SCLC. This dose escalation and expansion study plans to determine the maximum tolerated dose and/or optimal biological dose as a recommended Phase 2 dose for RO7051790, based on the safety, tolerability, pharmacokinetic and pharmacodynamic profiles observed after oral administration of RO7051790.

Trial Description

Primary Outcome:

  • Recommended Phase 2 Dose of RO7051790
  • Percentage of Participants With Adverse Events
  • Number of Participants With Dose-Limited Toxicities (DLTs)
  • Maximum Tolerated Dose (MTD) of RO7051790
Secondary Outcome:
  • Overall Survival (OS)
  • Maximum Observed Plasma Concentration (Cmax) of RO7051790
  • Minimum Observed Plasma Trough Concentration (Cmin) of RO7051790
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of RO7051790
  • Plasma Decay Half-Life (t1/2) of RO7051790
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of RO7051790
  • Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau) of RO7051790
  • Apparent Oral Clearance (CL/F) of RO7051790
  • Apparent Volume of Distribution (Vz/F) of RO7051790
  • Accumulation Ratio (RA) of RO7051790
  • Percentage of Participants by Tumour Response According to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)
  • Percentage of Participants With Objective Response According to RECIST v1.1
  • Duration of Response According to RECIST v1.1
  • Progression-Free Survival (PFS) According to RECIST v1.1

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society