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Phase I Trial of ONX-0801 Once Weekly or Alternate Weekly

NCT02360345 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2024-09-26

No results posted yet for this study

Summary

This is an open label, single-centre dose escalation phase 1 clinical trial of ONX-0801.

The study will evaluate two schedules of ONX-0801 concurrently: once weekly and alternate week dosing, of repeated 28-day treatment cycles.

The study will consist of two stages: the dose escalation phase, in which the recommended phase II dose will be determined; and the expansion phase, in which up to 30 patients will be treated at the recommended phase II dose and schedule to further support the design of subsequent trials of ONX-0801.

Conditions

Interventions

DRUG

ONX-0801

Sponsors & Collaborators

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER

  • Onyx Therapeutics, Inc.

    collaborator INDUSTRY

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Udai Banerji, MBBS, PhD · The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2020-01-31
Completion
2021-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02360345 on ClinicalTrials.gov