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Trial registered on ANZCTR


Registration number
ACTRN12621000479808
Ethics application status
Approved
Date submitted
12/02/2021
Date registered
22/04/2021
Date last updated
22/04/2021
Date data sharing statement initially provided
22/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An interventional study to safety, tolerability (how well a substance is tolerated by patients), and Pharmacokinetics (PK, the measure of how the human body processes a substance) of different dosages of Auceliciclib when given to patients with advanced solid tumours as either the only treatment, or in patients with a specific type of cancer, Glioblastoma multiforme (GBM), when given together with a standard of care treatment, Temozolomide (TMZ).
Scientific title
A Phase 1a/b, open-label, dose-exploration, combination/ expansion study to evaluate the safety, tolerability and pharmacokinetics of Auceliciclib in advanced solid tumours and in combination with temozolomide in recurrent or newly diagnosed Glioblastoma multiforme (GBM).
Secondary ID [1] 303410 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AugmenTation of Targeted therapy with Auceliciclib, a highly potent and selective CDK4/6 inhibitor- Phase 1a/b trial (ATTACK-1 trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 320700 0
Glioblastoma multiforme (GBM) 321293 0
Ovarian cancer 321294 0
Colorectal cancer 321295 0
Solid tumors 321296 0
Condition category
Condition code
Cancer 318544 318544 0 0
Brain
Cancer 319080 319080 0 0
Ovarian and primary peritoneal
Cancer 319081 319081 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will continue on the study until evidence of disease progression or unacceptable toxicities for all cohorts.

One cohort will be recruited sequentially for each dose level in the Dose Exploration Phase. All participants receive each dose in the Dose Exploration Phase until the maximum tolerated dose is reached.

Dose Exploration Phase involves participants with solid tumors, Disease Expansion Phase Arm 1 involves those with ovarian cancer. Disease Expansion Phase, Arm 2 involves participants with colorectal cancer. Disease Expansion Phase, Arm 3 involves participants with Glioblastoma multiforme (GBM).

For Dose Exploration and Disease Expansion (Arms 1 & 2) phases, Auceliciclib oral capsules will be administered daily for 21 days of each cycle.
For Disease Expansion phase (Arm 3), Auceliciclib will be administered daily for 16 days of each cycle and TMZ administered for 5 days of each cycle.

Dose Exploration Phase planned doses:
• Dose level 1: 50 mg on Days 1-21* of each 28-day cycle;
• Dose level 2: 100 mg on Days 1-21* of each 28-day cycle;
• Dose level 3: 150 mg on Days 1-21* of each 28-day cycle;
• Dose level 4: 250 mg on Days 1-21* of each 28-day cycle;
• Dose level 5: 350 mg on Days 1-21* of each 28-day cycle.
* For Cycle 1, Auceliciclib is given on Day 1 and on Days 3-21

Dose and Disease Expansion Phase dosage of Auceliciclib will be the maximum tolerated dose (MTD) determined from the Dose Exploration Phase.
Patients in Arm 3 of the Dose and Disease Expansion Phase (those with Glioblastoma multiforme [GBM]) will be administered Temozolomide (TMZ) in combination with Auceliciclib. Patients will continue receiving study medication until evidence of disease progression or unacceptable toxicities.
Intervention code [1] 319713 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326503 0
To assess the safety and tolerability of Auceliciclib in patients with advanced solid tumours, who have failed treatment with available therapies known to be active for treatment of their corresponding disease (Dose Exploration Phase).
This will be assessed by looking at the incidence, type, and severity of adverse events; dose limiting toxicities (DLTs); and changes from baseline in vital sign measurements, body weight, physical examination findings, clinical laboratory parameters, electrocardiogram (ECG) parameters.
Timepoint [1] 326503 0
Adverse event information will be recorded from the time of first treatment administration until end of study.
DLTs will be recorded from the time of first treatment administration until Day 28 of Cycle 1.
Vital signs (blood pressure, pulse rate, respiratory rate, temperature) will be measured using a digital sphygmomanometer, visual measurements and a digital thermometer respectively at Screening, pre-dose on Day 1 Cycle 1 (baseline), 3 and 6 hours post dose on Day 1 Cycle 1, 24 and 48 hours post dose Cycle 1, pre-dose on Days 8, 15, and 21 Cycle 1, Day 22 Cycle 1, pre-dose on Days 1 and 15 Cycle 2, pre-dose on Day 1 Cycle 3 and all subsequent cycles, and End of Study.
Body weight will be measured at Screening, pre-dose Day 1 Cycle 1 (baseline), pre-dose on Day 1 Cycle 2 and all subsequent cycles, and End of Study.
A full physical examination will be performed at Screening (baseline) and End of Study, with symptom-directed examinations performed pre-dose on Day 1 Cycle 1, Day 2 Cycle 1, pre-dose on Days 3, 8, 15, and 21 Cycle 1, Day 22 Cycle 1, pre-dose on Days 1 and 15 Cycle 2, pre-dose on Day 1 Cycle 3 and all subsequent cycles.
Clinical laboratory parameters (haematology, chemistry, coagulation, urinalysis) will be tested by collecting blood samples at Screening, pre-dose on Day 1 Cycle 1 (baseline), Day 2 Cycle 1, pre-dose on Days 8 and 15 Cycle 1, Day 22 Cycle 1, Day 15 Cycle 2, pre-dose Cycle 3 and all subsequent cycles, and End of Study.
Triplicate ECGs will be taken at Screening and pre-dose on Day 1 Cycle 1 (baseline). Single ECGs will be taken pre-dose on Days 8 and 15 Cycle 1, pre-dose on Day 1 Cycle 2 and all subsequent cycles and End of Study.
Primary outcome [2] 326504 0
To further assess the safety and tolerability of Auceliciclib in patients with ovarian and colorectal cancer (Arms 1 and 2 of the Dose and Disease Expansion Phase).
This will be assessed by looking at the incidence, type, and severity of adverse events; dose limiting toxicities (DLTs); and changes from baseline in vital sign measurements, body weight, physical examination findings, clinical laboratory parameters, electrocardiogram (ECG) parameters.
Timepoint [2] 326504 0
Adverse event information will be recorded from the time of first treatment administration until end of study.
DLTs will be recorded from the time of first treatment administration until Day 28 of Cycle 1.
Vital signs (blood pressure, pulse rate, respiratory rate, temperature) will be measured using a digital sphygmomanometer, visual measurements and a digital thermometer respectively at Screening, pre-dose on Day 1 Cycle 1 (baseline), pre-dose on Day 15 Cycle 1, pre-dose on Day 1 Cycle 2 and all subsequent cycles, and End of Study.
Body weight will be measured at Screening, pre-dose Day 1 Cycle 1 (baseline), pre-dose on Day 15 Cycle 1, pre-dose on Day 1 Cycle 2 and all subsequent cycles, and End of Study.
A full physical examination will be performed at Screening (baseline) and End of Study, with symptom-directed examinations performed pre-dose on Day 1 Cycle 1, pre-dose on Day 15 Cycle 1, pre-dose on Day 1 Cycle 2 and all subsequent cycles.
Clinical laboratory parameters (haematology, chemistry, coagulation, urinalysis) will be tested by collecting blood samples at Screening, pre-dose on Day 1 Cycle 1 (baseline), pre-dose on Day 17 Cycle 1, Day 22 Cycle 1, pre-dose on Day 17 Cycle 2, pre-dose on Day 1 Cycle 3 and all subsequent cycles, and End of Study.
Triplicate ECGs will be taken at Screening and pre-dose on Day 1 Cycle 1 (baseline). Single ECGs will be taken pre-dose on Day 15 Cycle 1, pre-dose on Day 1 Cycle 2 and all subsequent cycles, and End of Study.
Primary outcome [3] 326505 0
To assess the safety and tolerability of Auceliciclib in combination with TMZ in patients with recurrent or newly diagnosed GBM, who have completed concomitant phase of Temozolomide chemoradiation (42 days of daily TMZ treatment, in combination with radiotherapy). (Arm 3 of the Dose and Disease Expansion Phase).
This will be assessed by looking at the incidence, type, and severity of adverse events; dose limiting toxicities (DLTs); and changes from baseline in vital sign measurements, body weight, physical examination findings, clinical laboratory parameters, electrocardiogram (ECG) parameters.
Timepoint [3] 326505 0
Adverse event information will be recorded from the time of first treatment administration until end of study.
DLTs will be recorded from the time of first treatment administration until Day 28 of Cycle 1.
Vital signs (blood pressure, pulse rate, respiratory rate, temperature) will be measured using a digital sphygmomanometer, visual measurements and a digital thermometer respectively at Screening, pre-dose on Day 1 Cycle 1 (baseline), pre-dose on Day 17 Cycle 1, Day 22 Cycle 1, pre-dose on Day 1 Cycle 2, pre-dose on Day 17 Cycle 2, pre-dose on Day 1 Cycle 3 and all subsequent cycles, and End of Study.
Body weight will be measured at Screening, pre-dose Day 1 Cycle 1 (baseline), pre-dose on Day 1 Cycle 2 and all subsequent cycles, and End of Study.
A full physical examination will be performed at Screening (baseline) and End of Study, with symptom-directed examinations performed pre-dose on Day 1 Cycle 1, pre-dose on Day 17 Cycle 1, Day 22 Cycle 1, pre-dose on Day 1 Cycle 2, pre-dose on Day 17 Cycle 2, pre-dose on Day 1 Cycle 3 and all subsequent cycles.
Clinical laboratory parameters (haematology, chemistry, coagulation, urinalysis) will be tested by collecting blood samples at Screening, pre-dose on Day 1 Cycle 1 (baseline), pre-dose on Day 15 Cycle 1, pre-dose on Day 1 Cycle 2 and all subsequent cycles, and End of Study.
Triplicate ECGs will be taken at Screening, pre-dose on Day 1 Cycle 1 (baseline), and End of Study. Single ECGs will be taken pre-dose on Day 17 Cycle 1, Day 22 Cycle 1, and pre-dose on Day 17 Cycle 2.
Secondary outcome [1] 391705 0
To determine the MTD and Recommended Phase 2 dose (RP2D) of Auceliciclib in patients with advanced solid tumours (Dose Exploration Phase).
This will be assessed by looking at the incidence of DLTs according to the MTD/R2PD evaluation process.
The MTD will be the highest dose level at which less than 1/3 patients experience DLT in the first cycle. A minimum of 6 patients must be enrolled at the MTD level, per dose escalation study design criteria. If the MTD is not reached following completion of dose level 5, a protocol amendment may be submitted to the Human Research Ethics Committee (HREC) in order to include the evaluation of higher dose levels.
The RP2D will be determined by the SRC according to the safety, tolerability and pharmacokinetics of Auceliciclib observed in the dose escalation stage, as well as other available data. The RP2D will not exceed the MTD.
Timepoint [1] 391705 0
DLTs will be recorded from the time of first treatment administration until Day 28 of Cycle 1.
Secondary outcome [2] 391706 0
To evaluate the pharmacokinetics (PK) of Auceliciclib in patients with advanced solid tumours (Dose Exploration Phase).
Blood samples will be collected and the following PK parameters will be assessed in plasma:
• Maximum observed concentration (Cmax)
• Time to Cmax (tmax)
• Area under the drug concentration-time curve, from time zero to time t (AUC0-t)
• Apparent terminal elimination half-life (t1/2)
Timepoint [2] 391706 0
PK samples will be collected from pre-dose of first treatment administration until pre-dose Day 1 of Cycle 2. i.e. Cycle 1: Day 1-3; within 10 minutes prior to dosing and at 0.5, 1, 2, 3, 4, 6, 8, 24, and 48 hours post dose. Day 8 & 15; within 10 minutes prior to dosing. Day 21-22; within 10 minutes prior to dosing and at 0.5, 1, 2, 3, 4, 6, 8 and 24hours post dose. Cycle 2: Day 1; within 10 minutes prior to dosing.
Secondary outcome [3] 391707 0
To evaluate the preliminary efficacy of Auceliciclib when administered as a monotherapy in patients with advanced solid tumours (Dose Exploration Phase).

This is a composite objective evaluating the preliminary efficacy. The following is a description of how the objective will be achieved.

The preliminary anti-tumour activity of Auceliciclib will be assessed by:
• Frequency, quality and durability of response per Response evaluation criteria in solid tumours (RECIST) 1.1 or Response assessment in neuro-oncology (RANO) criteria.

Efficacy endpoints will include (but will not be limited to):
• Objective response rate (ORR)
• Disease control rate (DCR).
The ORR is defined as the proportion of patients who achieve a partial response (PR) or complete response (CR) at any time on study.
DCR is defined as the proportion of patients with stable disease (SD) greater than or equal to 6 months (24 weeks), PR, or CR.
Timepoint [3] 391707 0
ECOG performance status will be assessed at Screening, Day 1 Cycle 1 (baseline), Day 15 Cycle 1, Day 1 Cycle 2, Day 15 Cycle 2, Day 1 Cycle 3 and all subsequent cycles, and End of Study.
Standard CT/MRI imaging assessments of the chest, abdomen, and pelvis, as well as of other regions where evaluable disease exists will be performed during Screening (baseline), following completion of dosing for Cycle 2 and every 9 weeks (3 cycles) thereafter (e.g. Cycle 5, 8, 11...) until disease progression occurs per RECIST 1.1 or RANO criteria.
Secondary outcome [4] 391708 0
To evaluate the preliminary efficacy of Auceliciclib when administered as a monotherapy in patients with ovarian and colorectal cancer (Arms 1 and 2 of the Dose and Disease Expansion Phase).

This is a composite objective evaluating the preliminary efficacy. The following is a description of how the objective will be achieved.

The preliminary anti-tumour activity of Auceliciclib will be assessed by:
• Frequency, quality and durability of response per RECIST 1.1 or RANO criteria.

Efficacy endpoints will include (but will not be limited to):
• ORR
• DCR.
Timepoint [4] 391708 0
ECOG performance status will be assessed at Screening (baseline), Day 15 Cycle 1, Day 1 Cycle 2 and all subsequent cycles, and End of Study.
Standard CT/MRI imaging assessments of the chest, abdomen, and pelvis, as well as of other regions where evaluable disease exists will be performed during Screening (baseline), following completion of dosing for Cycle 2 and every 9 weeks (3 cycles) thereafter (e.g. Cycle 5, 8, 11...) until disease progression occurs per RECIST 1.1 or RANO criteria.
Secondary outcome [5] 391709 0
To evaluate the preliminary efficacy of Auceliciclib when administered in combination with TMZ in patients with GBM (Arm 3 of the Dose and Disease Expansion Phase).

This is a composite objective evaluating the preliminary efficacy. The following is a description of how the objective will be achieved.

The preliminary anti-tumour activity of Auceliciclib will be assessed by:
• Changes in Neurologic Assessment in Neuro-Oncology (NANO) scoring assessment
• Frequency, quality and durability of response per RECIST 1.1 or RANO criteria.

Efficacy endpoints will include (but will not be limited to):
• ORR
• DCR.
Timepoint [5] 391709 0
ECOG performance status and NANO scale assessment will be assessed at Screening, Day 1 Cycle 1 (baseline), Day 1 Cycle 2 and all subsequent cycles, and End of Study.
Standard CT/MRI imaging assessments of the chest, abdomen, pelvis, and brain as well as of other regions where evaluable disease exists will be performed during Screening (baseline), following completion of dosing for Cycle 2 and every 9 weeks (3 cycles) thereafter (e.g. Cycle 5, 8, 11...) until disease progression occurs per RECIST 1.1 or RANO criteria.
Secondary outcome [6] 391710 0
To evaluate the pharmacodynamics (PD) of Auceliciclib in patients with advanced solid tumours. (Dose Exploration Phase).
PD parameters include molecular profiling, gene and protein expression.
Timepoint [6] 391710 0
Blood samples for PD will be collected pre-dose on Day 1 of each Cycle and End of Study.
If patients consent to tumour biopsy, samples will be collected at any time during the screening window up to Cycle 1 Day 1 (prior to dose administration), and anytime between Cycle 2 Day 1 and Cycle 4 Day 28.
Secondary outcome [7] 391711 0
To evaluate the PD of Auceliciclib in patients with ovarian and colorectal cancer. (Arms 1 and 2 of the Dose and Disease Expansion Phase).
PD parameters include molecular profiling, gene and protein expression.
Timepoint [7] 391711 0
PD blood samples will be collected from pre-dose at Day 1 of each cycle from of first treatment administration and End of Study (EoS) visit.
PD tumor samples, if consented, will be collected at Screening and any time between Cycle 2, Day 1 and Cycle 4, Day 28.
If consented, additional PD tumor and CSF samples may be collected at any time throughout study, at time of tumor resection or CSF collection.
Secondary outcome [8] 391712 0
To evaluate the PD of Auceliciclib when administered in combination with TMZ in patients with GBM. (Arm 3 of the Dose and Disease Expansion Phase).
PD parameters include molecular profiling, gene and protein expression
Timepoint [8] 391712 0
PD blood samples will be collected from pre-dose at Day 1 of each cycle from of first treatment administration and End of Study (EoS) visit.
If consented, additional PD tumor and CSF samples may be collected at any time throughout study, at time of tumor resection or CSF collection.

Eligibility
Key inclusion criteria
1. Ability to understand and be willing to sign an informed consent form.
2. Male or female, greater than or equal to 18 years old at the time of screening.
3. Diagnosis of histologically or cytologically confirmed:
a. Locally advanced or metastatic cancer (all solid tumours) OR
b. Locally advanced or metastatic cancer (ovarian or colorectal cancers only) OR
c. High-grade glioma, such as GBM that are either:
i. Newly diagnosed high-grade glioma, GBM.
ii. Relapsed or recurrent high-grade glioma, GBM.
4. ECOG performance status of 0 to 2.
5. Able to take oral medications.
6. QTc > 460 msec (F), QTc > 450 msec (M).
7. Evidence of adequate cardiac function.
8. Evidence of adequate hepatic function at screening.
9. Adequate haematology laboratory assessment at screening.
10. Adequate coagulation laboratory assessments at screening.
11. Female patients must be of non-child-bearing potential.
12. If of child-bearing potential, must agree not to attempt to become pregnant.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior treatment with a CDK4/6 inhibitor.
2. Patients with symptomatic primary central nervous system (CNS) tumour, symptomatic CNS metastases, or untreated spinal cord compression that have moderate or severe symptoms.
3. Uncontrolled pleural effusion(s), pericardial effusion or ascites. Evidence of abnormal cardiac function Unable to swallow oral medications.
4. Gastrointestinal (GI) conditions that, in the opinion of the Investigator, could affect the absorption of study drug.
5. History of other malignancy within the past 2 years.

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



Intervention assignment
Other
Other design features
Participants will be assigned to different dosages depending on which cohort and/ or dose level they are enrolled into.
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Dose Exploration: Up to 30 patients will be enrolled across 5 dose escalation levels (6 patients per cohort). An optional cohort of up to 6 participants of Chinese origin may also be evaluated at the MTD, at the discretion of the Sponsor.
Dose and Disease Expansion: Up to 20 patients will be enrolled across three treatment arms.
The sample size for this study is based on clinical and practical considerations and not on a formal statistical power calculation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA,VIC
Recruitment hospital [1] 18682 0
Linear Clinical Research - Nedlands
Recruitment hospital [2] 18683 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 18684 0
Flinders Private Hospital - Bedford Park
Recruitment postcode(s) [1] 33121 0
3084 - Heidelberg
Recruitment postcode(s) [2] 33122 0
5042 - Bedford Park
Recruitment postcode(s) [3] 33119 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 307825 0
Commercial sector/Industry
Name [1] 307825 0
Aucentra Therapeutics Pty Ltd.
Address [1] 307825 0
Level 7, UniSA Cancer Research Institute, Building HB, North Terrace, Adelaide, SA 5000
Country [1] 307825 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Aucentra Therapeutics Pty Ltd.
Address
Level 7, UniSA Cancer Research Institute, Building HB, North Terrace, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 308534 0
None
Name [1] 308534 0
Address [1] 308534 0
Country [1] 308534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307830 0
Bellberry Limited Human Research Ethics Committee.
Ethics committee address [1] 307830 0
123 Glen Osmond Road, Eastwood SA 5063.
Ethics committee country [1] 307830 0
Australia
Date submitted for ethics approval [1] 307830 0
09/02/2021
Approval date [1] 307830 0
23/03/2021
Ethics approval number [1] 307830 0

Summary
Brief summary
This study will investigate the safety, tolerability (how well a substance is tolerated by patients), and pharmacokinetics (PK, the measure of how the human body processes a substance) of different doses of Auceliciclib in patients with advanced solid tumors, brain, ovarian or colorectal cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 and above, have been diagnosed with locally advanced or metastatic cancer (all solid tumors), locally advanced or metastatic cancer (ovarian or colorectal cancers only) or high-grade glioma

Study details
There are two stages to this study:
1)Dose exploration stage where 5 different doses of Auceliciclib will be used to determine the maximum tolerated dose for Auceliciclib in participants with any solid tumor. Each dose is administered daily between Days 1-21 of each 28 day cycle.
2) Disease Expansion stage where the dose determined from the first stage is used in participants with ovarian, colorectal (Arms 1 or 2) or brain cancer (Arm 3). Arms 1 and 2 are administered Auceliciclib daily between Days 1-21 of each 28 day cycle and Arm 3 is administered Auceliciclib daily between Days 1-16 and Temozolomide daily between Days 17-21 of each 28 day cycle.

Safety and tolerability will be assessed frequently in every cycle for both stages. PK for Auceliciclib in each cancer type will be assessed using blood samples.

It is hoped Auceliciclib will demonstrate potent and superior growth inhibition of cancer cells, improving overall survival with less associated toxicities than other similar compounds in patients with advanced solid tumors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108654 0
Prof Ganessan Kichenadasse
Address 108654 0
SOCRU, Suite 201, Level 2 Flinders Private Hospital, 1 Flinders Drive, Bedford Park SA 5042


Country 108654 0
Australia
Phone 108654 0
+61 8 8299 0706
Fax 108654 0
Email 108654 0
ganessan.kichenadasse@socru.org.au
Contact person for public queries
Name 108655 0
Mr Matthew Chong
Address 108655 0
Level 7, UniSA Cancer Research Institute, Building HB, North Terrace, Adelaide, SA 5000
Country 108655 0
Australia
Phone 108655 0
+61 8 8302 1587
Fax 108655 0
Email 108655 0
hello@aucentra.com
Contact person for scientific queries
Name 108656 0
Dr Paul Wabnitz
Address 108656 0
Level 7, UniSA Cancer Research Institute, Building HB, North Terrace, Adelaide, SA 5000
Country 108656 0
Australia
Phone 108656 0
+61 8 8302 1587
Fax 108656 0
Email 108656 0
hello@aucentra.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results