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

Sponsor
Peter MacCallum Cancer Centre, Australia
Study ID
NCT04801966
Status
Terminated

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trametinib — DRUG
    2 mg per day, continuous
  • Cobimetinib — DRUG
    60 mg/day for 21 days of a 28 day cycle
  • Binimetinib — DRUG
    45 mg/twice a day, continuous
  • Alpelisib — DRUG
    300 mg/day, continuous
  • Vemurafenib — DRUG
    960 mg/twice per day, continuous
  • Dabrafenib — DRUG
    150 mg/twicce per day, continuous
  • Encorafenib — DRUG
    450 mg/day, continuous
  • Palbociclib — DRUG
    125 mg/day, day 1-21 of a 28 day cycle
  • Olaparib — DRUG
    300 mg/twice per day, continuous
  • Ribociclib — DRUG
    600 mg/day, on day 1 -21 of a 28 day cycle
  • Abemaciclib — DRUG
    150 mg twice/day, continuous
  • Talazoparib — DRUG
    1 mg/day, on day 1 -28 of each 28 day cycle
  • Nivolumab — DRUG
    240 mg IV once every 2 weeks
  • Atezolizumab — DRUG
    1200 mg IV on Day 1 of a 21 day cycle
  • Pembrolizumab — DRUG
    200 mg IV on day 1 of a 21 day cycle

Study Details

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.

Key Dates

Start date
Sep 23, 2021
Status verified
May 2023
Primary completion
Dec 30, 2022
Completion
Dec 30, 2022

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    All participants will have an individualised treatment plan. The possible treatments that can be prescribed are as follows, they may be given as a single agent or in combination * Trametinib 2 mg/day * Cobimetinib 60 mg/day, on day 1-21 of each 28 day cycle (21 days on, 7 days off) * Binimetinib 45 mg/ twice a day * Alpelisib 300 mg/day * Vemurafenib 960 mg twice a day * Dabrafenib 150 mg twice a day * Encorafenib 450 mg/day * Palbociclib 125 mg/day, on day 1-21 of each 28 day cycle (21 days on, 7 days off) * Ribociclib 600 mg/day, on day 1-21 of each 28 day cycle (21 days on, 7 days off * Abemaciclib 150 mg twice a day * Olaparib 300 mg twice a day * Talazoparib 1 mg/day * Nivolumab 240 mg IV once every two weeks * Atezolizumab 1200 mg IV on day 1 of a 21 day cycle * Pembrolizumab 200 mg IV on day 1 of a 21 day cycle

Primary Outcome Measure

Safety of the study design as mechanism for administering individualised therapies to individuals with incurable malignancies [ Time Frame: At the end of the study, approximately 5 years after the first participant commences treatment ]

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