CancerTAILORNCT04801966
Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study
A study testing Trametinib, Cobimetinib and Binimetinib in people with Cancer, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Trametinib, Cobimetinib and Binimetinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Sep 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient or their parent(s)/legal guardian(s) has provided written informed consent using the main study PICF
- Continues to meet all the inclusion criteria as per the TRIAGE Framework protocol as follows:
- Male or female patient, aged 2 years or older
- Patient has pathologically confirmed locally advanced, incurable or metastatic cancer of any histological type
- Have an available TRIAGE sub-study with a matched therapy
- Documented progression following standard therapy, or for whom, in the opinion of the Investigator, no appropriate standard therapy exists
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- Life expectancy of > 3 months
- Adequate performance status:
- 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)
- Treatment regimen and schedule of assessments that has been approved by the TAILOR Study Committee
- Approved treatment is obtainable
- 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)
- 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
- 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
- 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.
- 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.
Who cannot join
- One or more of the exclusion criteria as per the TRIAGE Framework protocol applies as follows:
- Significant cardiovascular disease
- 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
- 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
- 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)
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- 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
- History of leptomeningeal disease unless a primary brain tumour
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Some advanced cancers have numerous standard treatment options that have proven efficacy in clinical trials. However, in other cancers, there may be few or no standard treatment options with proven efficacy as determined in a large clinical trial. This may be particularly the case for rare cancers in which there is a lack of clinical research. When seriously ill patients run out of standard treatment options, they will often consider non-standard treatment options (such as treatments that are currently unapproved by the regulatory agency for the given indication). The majority of clinicians and researchers agree that this is best received in a clinical trial setting as this provides ethical and clinical oversight, as well as addresses prospectively defined research questions which can be publicly reported. This allows the conclusions of the research to be available to the entire clinical and research community.
In general, an access program enables patient access to a non-reimbursed therapeutic agent, outside of a clinical trial setting. Compassionate access is typically for therapeutics that are not yet approved or TGA registered, and are still considered investigational. In general, there is a negotiation between the pharmaceutical company and the clinician and patient regarding access to the therapeutic agent, as well as whether the medicine will be provided free of charge, or on some form of cost-sharing arrangement. In Australia, access to TGA non-registered medicines also requires an application via the "Special Access Scheme". For most cancer patients, the use falls under category A, for a patient defined as seriously ill. This sub-study generally pertains to compassionate access to therapeutic agents. Given the ad hoc nature of compassionate access for patients, there is relatively little reported data on clinical outcomes.
Compassionate access is an established process with increasing demands. This study is designed to provide a framework for which patients treated with compassionate access therapeutics can register, so that some of the limitations of ad hoc compassionate access programs can be overcome.
A study committee will prospectively assess each individual patient's detailed treatment approach in an objective and time-efficient manner. If approved, the patient may be eligible to register into the treatment phase of the study. The study committee is essential to provide a balanced approach to understanding the rationale for the study treatment, as well as potential safety issues that may arise. As previously reported, this is an essential component to improving patient oversight as well as equity
- Conditions
- Cancer
- Being tested
- Trametinib, Cobimetinib, Binimetinib, Alpelisib, Vemurafenib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrametinibDrug
2 mg per day, continuous
CobimetinibDrug
60 mg/day for 21 days of a 28 day cycle
BinimetinibDrug
45 mg/twice a day, continuous
AlpelisibDrug
300 mg/day, continuous
VemurafenibDrug
960 mg/twice per day, continuous
DabrafenibDrug
150 mg/twicce per day, continuous
EncorafenibDrug
450 mg/day, continuous
PalbociclibDrug
125 mg/day, day 1-21 of a 28 day cycle
OlaparibDrug
300 mg/twice per day, continuous
RibociclibDrug
600 mg/day, on day 1 -21 of a 28 day cycle
AbemaciclibDrug
150 mg twice/day, continuous
TalazoparibDrug
1 mg/day, on day 1 -28 of each 28 day cycle
NivolumabDrug
240 mg IV once every 2 weeks
AtezolizumabDrug
1200 mg IV on Day 1 of a 21 day cycle
PembrolizumabDrug
200 mg IV on day 1 of a 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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 Receives: Drug: Trametinib; Drug: Cobimetinib; Drug: Binimetinib; Drug: Alpelisib; Drug: Vemurafenib; Drug: Dabrafenib; Drug: Encorafenib; Drug: Palbociclib; Drug: Olaparib; Drug: Ribociclib; Drug: Abemaciclib; Drug: Talazoparib; Drug: Nivolumab; Drug: Atezolizumab; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the study design as mechanism for administering individualised therapies to individuals with incurable malignancies
Severity of adverse events as determined by NCI CTCAE v5.0
Measured: At the end of the study, approximately 5 years after the first participant commences treatment
Feasibility of the study design as mechanism for administering individualised therapies to individuals with incurable malignancies
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
Measured: At the end of the study, approximately 5 years after the first participant commences treatment
Secondary outcomes (1)
Efficacy of individualised therapies in patients registered to the study
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)
Measured: At the end of the study, approximately 5 years after the first participant commences treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start23 Sep 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Luen, MBBS, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801966
- Sponsor's protocol ID
- 20/029
- Acronym
- TAILOR
- Status last verified
- May 2023
- First submitted
- 13 Mar 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Sponsor will consider individual requests to share data
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study
- ClinicalTrials.gov ID
- NCT04801966
- Acronym / sponsor ID
- TAILOR / 20/029
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Some advanced cancers have numerous standard treatment options that have proven efficacy in clinical trials. However, in other cancers, there may be few or no standard treatment options with proven efficacy as determined in a large clinical trial. This may be particularly the case for rare cancers in which there is a lack of clinical research. When seriously ill patients run out of standard treatment options, they will often consider non-standard treatment options (such as treatments that are currently unapproved by the regulatory agency for the given indication). The majority of clinicians and researchers agree that this is best received in a clinical trial setting as this provides ethical and clinical oversight, as well as addresses prospectively defined research questions which can be publicly reported. This allows the conclusions of the research to be available to the entire clinical and research community.
In general, an access program enables patient access to a non-reimbursed therapeutic agent, outside of a clinical trial setting. Compassionate access is typically for therapeutics that are not yet approved or TGA registered, and are still considered investigational. In general, there is a negotiation between the pharmaceutical company and the clinician and patient regarding access to the therapeutic agent, as well as whether the medicine will be provided free of charge, or on some form of cost-sharing arrangement. In Australia, access to TGA non-registered medicines also requires an application via the "Special Access Scheme". For most cancer patients, the use falls under category A, for a patient defined as seriously ill. This sub-study generally pertains to compassionate access to therapeutic agents. Given the ad hoc nature of compassionate access for patients, there is relatively little reported data on clinical outcomes.
Compassionate access is an established process with increasing demands. This study is designed to provide a framework for which patients treated with compassionate access therapeutics can register, so that some of the limitations of ad hoc compassionate access programs can be overcome.
A study committee will prospectively assess each individual patient's detailed treatment approach in an objective and time-efficient manner. If approved, the patient may be eligible to register into the treatment phase of the study. The study committee is essential to provide a balanced approach to understanding the rationale for the study treatment, as well as potential safety issues that may arise. As previously reported, this is an essential component to improving patient oversight as well as equity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Trametinib, Drug: Cobimetinib, Drug: Binimetinib, Drug: Alpelisib, Drug: Vemurafenib, Drug: Dabrafenib, Drug: Encorafenib, Drug: Palbociclib, Drug: Olaparib, Drug: Ribociclib, Drug: Abemaciclib, Drug: Talazoparib, Drug: Nivolumab, Drug: Atezolizumab, Drug: PembrolizumabAll 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 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- Patient or their parent(s)/legal guardian(s) has provided written informed consent using the main study PICF
- Continues to meet all the inclusion criteria as per the TRIAGE Framework protocol as follows:
- Treatment regimen and schedule of assessments that has been approved by the TAILOR Study Committee
- Approved treatment is obtainable
- 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)
Key exclusion criteria (12 listed)
- One or more of the exclusion criteria as per the TRIAGE Framework protocol applies as follows:
- 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)
- Symptomatic, or actively progressing CNS metastases (unless a primary brain tumour).Patients with a history of treated
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trametinib2 mg per day, continuous | Drug | Treatment |
| Cobimetinib60 mg/day for 21 days of a 28 day cycle | Drug | Treatment |
| Binimetinib45 mg/twice a day, continuous | Drug | Treatment |
| Alpelisib300 mg/day, continuous | Drug | Treatment |
| Vemurafenib960 mg/twice per day, continuous | Drug | Treatment |
| Dabrafenib150 mg/twicce per day, continuous | Drug | Treatment |
| Encorafenib450 mg/day, continuous | Drug | Treatment |
| Palbociclib125 mg/day, day 1-21 of a 28 day cycle | Drug | Treatment |
| Olaparib300 mg/twice per day, continuous | Drug | Treatment |
| Ribociclib600 mg/day, on day 1 -21 of a 28 day cycle | Drug | Treatment |
| Abemaciclib150 mg twice/day, continuous | Drug | Treatment |
| Talazoparib1 mg/day, on day 1 -28 of each 28 day cycle | Drug | Treatment |
| Nivolumab240 mg IV once every 2 weeks | Drug | Treatment |
| Atezolizumab1200 mg IV on Day 1 of a 21 day cycle | Drug | Treatment |
| Pembrolizumab200 mg IV on day 1 of a 21 day cycle | Drug | Treatment |
Primary outcome
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
Severity of adverse events as determined by NCI CTCAE v5.0
Feasibility 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
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
1 secondary outcome
Efficacy of individualised therapies in patients registered to the study
Time frame: At the end of the study, approximately 5 years after the first participant commences treatment
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No. The Sponsor will consider individual requests to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Luen, MBBS principal investigator
Peter MacCallum Cancer Centre, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trametinib, Cobimetinib and Binimetinib in people with Cancer, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.