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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04801966
Registration number
NCT04801966
Ethics application status
Date submitted
13/03/2021
Date registered
17/03/2021
Date last updated
10/05/2023
Titles & IDs
Public title
Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study
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Scientific title
Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study
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Secondary ID [1]
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20/029
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Universal Trial Number (UTN)
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Trial acronym
TAILOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Trametinib
Treatment: Drugs - Cobimetinib
Treatment: Drugs - Binimetinib
Treatment: Drugs - Alpelisib
Treatment: Drugs - Vemurafenib
Treatment: Drugs - Dabrafenib
Treatment: Drugs - Encorafenib
Treatment: Drugs - Palbociclib
Treatment: Drugs - Olaparib
Treatment: Drugs - Ribociclib
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Talazoparib
Treatment: Drugs - Nivolumab
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Pembrolizumab
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
Treatment: Drugs: Trametinib
2 mg per day, continuous
Treatment: Drugs: Cobimetinib
60 mg/day for 21 days of a 28 day cycle
Treatment: Drugs: Binimetinib
45 mg/twice a day, continuous
Treatment: Drugs: Alpelisib
300 mg/day, continuous
Treatment: Drugs: Vemurafenib
960 mg/twice per day, continuous
Treatment: Drugs: Dabrafenib
150 mg/twicce per day, continuous
Treatment: Drugs: Encorafenib
450 mg/day, continuous
Treatment: Drugs: Palbociclib
125 mg/day, day 1-21 of a 28 day cycle
Treatment: Drugs: Olaparib
300 mg/twice per day, continuous
Treatment: Drugs: Ribociclib
600 mg/day, on day 1 -21 of a 28 day cycle
Treatment: Drugs: Abemaciclib
150 mg twice/day, continuous
Treatment: Drugs: Talazoparib
1 mg/day, on day 1 -28 of each 28 day cycle
Treatment: Drugs: Nivolumab
240 mg IV once every 2 weeks
Treatment: Drugs: Atezolizumab
1200 mg IV on Day 1 of a 21 day cycle
Treatment: Drugs: Pembrolizumab
200 mg IV on day 1 of a 21 day cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety of the study design as mechanism for administering individualised therapies to individuals with incurable malignancies
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Assessment method [1]
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Severity of adverse events as determined by NCI CTCAE v5.0
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Timepoint [1]
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At the end of the study, approximately 5 years after the first participant commences treatment
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Primary outcome [2]
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Feasibility of the study design as mechanism for administering individualised therapies to individuals with incurable malignancies
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Assessment method [2]
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Feasibility measured by:
Number of treatment plans proposed to the study committee Proportion of treatment plans proposed that are approved Proportion of approved plans for which study drug(s) were obtained Proportion of approved plans for which study drug(s) were obtained and patient was registered on the trial
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Timepoint [2]
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At the end of the study, approximately 5 years after the first participant commences treatment
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Secondary outcome [1]
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Efficacy of individualised therapies in patients registered to the study
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Assessment method [1]
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Efficacy measured by:
Objective response rate (ORR), defined as the proportion of patients with an objective response (partial response [PR] or complete response [CR]), as determined by the Investigator by RECIST 1.1 (or RANO for primary CNS cancers or Cheson IWG for lymphomas)
Clinical benefit rate (CBR), defined as the proportion of patients with CR, PR, or stable disease for = 4 months, as determined by the Investigator by RECIST 1.1 (or RANO for primary CNS cancers or Cheson IWG for lymphomas)
Progression-free survival (PFS), defined as the time from registration to the first occurrence of disease progression, as determined by the Investigator according to RECIST 1.1 or RANO for primary CNS cancers or Cheson IWG for lymphomas, or death from any cause, whichever occurs first.
Overall survival (OS)
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Timepoint [1]
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At the end of the study, approximately 5 years after the first participant commences treatment
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Eligibility
Key inclusion criteria
1. Patient or their parent(s)/legal guardian(s) has provided written informed consent
using the main study PICF
2. Continues to meet all the inclusion criteria as per the TRIAGE Framework protocol as
follows:
1. Male or female patient, aged 2 years or older
2. Patient has pathologically confirmed locally advanced, incurable or metastatic
cancer of any histological type
3. Have an available TRIAGE sub-study with a matched therapy
4. Documented progression following standard therapy, or for whom, in the opinion of
the Investigator, no appropriate standard therapy exists
5. Life expectancy of > 3 months
6. Adequate performance status:
i. For patients aged 18 years or over, Eastern Cooperative Oncology Group (ECOG)
performance status = 2 (appendix 1) ii. For patients aged 17 years, Karnofsky score =
50 (appendix 2) iii. For patients aged 16 years or under, Lansky score = 50 (appendix
3)
3. Treatment regimen and schedule of assessments that has been approved by the TAILOR
Study Committee
4. Approved treatment is obtainable
5. Patient has measurable disease or evaluable disease as defined by RECIST 1.1 (or RANO
criteria for primary CNS cancers or the Cheson (IWG) revised response criteria for
lymphomas)
6. Patient must have adequate bone marrow, hepatic and renal function within 7 days prior
to registration:
- ANC = 1.5 x 109/L
- Platelet count = 100 x 109/L (platelet count = 50 x 109/L for haematological
malignancy indications)
- ALT = 2.5x ULN, unless liver metastases or invasion are present, in which case it
must be = 5x ULN
- AST = 2.5x ULN, unless liver metastases or invasion are present, in which case it
must be = 5x ULN
- Total bilirubin = 1.5x ULN except patients with Gilbert's Syndrome, who are
eligible in consultation with their physician
- Serum creatinine = 1.5x ULN
7. Patient is willing and able to comply with the protocol for the duration of the study
including undergoing, treatment, and scheduled visits and examination including follow
up
8. Female patients of childbearing potential must have a negative serum pregnancy test at
screening for the main study and agree to use highly effective methods of birth
control while receiving approved treatment through to the time frame specified in the
approved ITAP after the last dose. Patients of childbearing potential are those who
have not been surgically sterilised or have not been free from menses for > 1 year.
9. Sexually active males must agree to use a condom during intercourse while taking the
approved treatment through to the time frame specified in the approved ITAP after the
last dose and should not father a child in this period.
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Minimum age
2
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. One or more of the exclusion criteria as per the TRIAGE Framework protocol applies as
follows:
1. Significant cardiovascular disease
2. Any other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding that contraindicates the use of an investigational
drug, may affect the interpretation of the results, or may render the patient at
high risk from treatment complications
3. Other co-morbidities or conditions that may compromise assessment of key outcomes
or in the opinion of the clinician, limit the ability of the patient to comply
with the protocol
2. Any unresolved toxicity (=CTCAE grade 2) from previous anti-cancer therapy, with the
exception of alopecia.
Patients with irreversible toxicity that is not reasonably expected to be exacerbated
by the investigational product(s) may be included (e.g. hearing loss, peripheral
neuropathy)
3. Symptomatic, or actively progressing CNS metastases (unless a primary brain
tumour).Patients with a history of treated
CNS lesions are eligible, provided that all of the following criteria are met:
Measurable disease per RECIST 1.1 must be present outside the CNS Metastases are
limited to the cerebellum or the supratentorial region (i.e. no metastases to the
midbrain, pons, medulla, or spinal cord) There is no clinical evidence of interim
progression between completion of CNS-directed therapy and registration on the study
(radiological re-assessment is not required) The patient has not received radiotherapy
within 14 days prior to registration Anticonvulsant therapy at a stable dose is
permitted
4. History of leptomeningeal disease unless a primary brain tumour
5. Known active infection including tuberculosis, HBV, HCV, or HIV. Patients with a past
or resolved HBV infection (defined as the presence of HBcAb and absence of HBsAg) are
eligible. Patients with a past or resolved HCV infection are eligible only if
polymerase chain reaction is negative for HCV RNA
Additional inclusion and/or exclusion criteria for the main study will be stipulated in the
approved Individualised Treatment and Assessment Plan as each treatment regimen is expected
to have specific requirements.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/12/2022
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Sample size
Target
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Accrual to date
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Final
3
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04801966
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen Luen, MBBS
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Address
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Peter MacCallum Cancer Centre, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04801966
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