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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study
Secondary ID [1] 0 0
20/029
Universal Trial Number (UTN)
Trial acronym
TAILOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of the study design as mechanism for administering individualised therapies to individuals with incurable malignancies
Timepoint [1] 0 0
At the end of the study, approximately 5 years after the first participant commences treatment
Primary outcome [2] 0 0
Feasibility of the study design as mechanism for administering individualised therapies to individuals with incurable malignancies
Timepoint [2] 0 0
At the end of the study, approximately 5 years after the first participant commences treatment
Secondary outcome [1] 0 0
Efficacy of individualised therapies in patients registered to the study
Timepoint [1] 0 0
At the end of the study, approximately 5 years after the first participant commences treatment

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.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2022
Sample size
Target
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04801966
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Luen, MBBS
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04801966