Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Summary

This study is looking at outcomes in people with advanced cancers who have exhausted standard treatment options and are accessing off indication or unregistered drugs or combinations of drugs through compassionate access from the manufacturer.

Conditions

• Cancer

Interventions

DRUG

Trametinib

2 mg per day, continuous

DRUG

Cobimetinib

60 mg/day for 21 days of a 28 day cycle

DRUG

Binimetinib

45 mg/twice a day, continuous

DRUG

Alpelisib

300 mg/day, continuous

DRUG

Vemurafenib

960 mg/twice per day, continuous

DRUG

Dabrafenib

150 mg/twicce per day, continuous

DRUG

Encorafenib

450 mg/day, continuous

DRUG

Palbociclib

125 mg/day, day 1-21 of a 28 day cycle

DRUG

Olaparib

300 mg/twice per day, continuous

DRUG

Ribociclib

600 mg/day, on day 1 -21 of a 28 day cycle

DRUG

Abemaciclib

150 mg twice/day, continuous

DRUG

Talazoparib

1 mg/day, on day 1 -28 of each 28 day cycle

DRUG

Nivolumab

240 mg IV once every 2 weeks

DRUG

Atezolizumab

1200 mg IV on Day 1 of a 21 day cycle

DRUG

Pembrolizumab

200 mg IV on day 1 of a 21 day cycle

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia

  lead OTHER

Principal Investigators

• Stephen Luen, MBBS · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-23

Primary Completion

2022-12-30

Completion

2022-12-30

Countries

• Australia

Study Locations