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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/NCT03507543




Registration number
NCT03507543
Ethics application status
Date submitted
8/01/2018
Date registered
25/04/2018
Date last updated
30/03/2021

Titles & IDs
Public title
The Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors
Scientific title
A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
IMP4297-2016-AU01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumours 0 0
Breast Cancer 0 0
Ovarian Cancer 0 0
Prostate Cancer 0 0
Primary Peritoneal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IMP4297

Experimental: IMP4297 -


Treatment: Drugs: IMP4297
The dose levels will be escalated following a modified 3+3 dose escalation scheme.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The AEs (adverse event) of single and multiple doses of IMP4297 administered to participants with advanced solid tumors.
Timepoint [1] 0 0
Each visit after IMP4297 administrated (through study completion, an average of 10 months)
Primary outcome [2] 0 0
The maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLTs) of IMP4297.
Timepoint [2] 0 0
Within 28 days after IMP4297 administrated
Secondary outcome [1] 0 0
Area Under Curve [AUClast, AUCINF and AUCtau]
Timepoint [1] 0 0
Within 7 days after firstly single dose administrated
Secondary outcome [2] 0 0
Area Under Curve [AUClast, AUCINF and AUCtau]
Timepoint [2] 0 0
Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)
Secondary outcome [3] 0 0
Maximum plasma concentration (Cmax)
Timepoint [3] 0 0
Within 7 days after firstly single dose administrated
Secondary outcome [4] 0 0
Maximum plasma concentration (Cmax)
Timepoint [4] 0 0
Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)
Secondary outcome [5] 0 0
Time at which Cmax occurred (Tmax)
Timepoint [5] 0 0
Within 7 days after firstly single dose administrated
Secondary outcome [6] 0 0
Time at which Cmax occurred (Tmax)
Timepoint [6] 0 0
Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)
Secondary outcome [7] 0 0
Trough Concentrations (Ctrough)
Timepoint [7] 0 0
Within 7 days after firstly single dose administrated
Secondary outcome [8] 0 0
Trough Concentrations (Ctrough)
Timepoint [8] 0 0
Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)
Secondary outcome [9] 0 0
Clearance (CL/F)
Timepoint [9] 0 0
Within 7 days after firstly single dose administrated
Secondary outcome [10] 0 0
Clearance (CL/F)
Timepoint [10] 0 0
Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)
Secondary outcome [11] 0 0
Volume of distribution (Vd/F)
Timepoint [11] 0 0
Within 7 days after firstly single dose administrated
Secondary outcome [12] 0 0
Volume of distribution (Vd/F)
Timepoint [12] 0 0
Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)

Eligibility
Key inclusion criteria
1. Signed Informed Consent Form

2. Age greater than or equal to 18 years

3. Histologically or cytologically documented, incurable, advanced solid malignancy that
has progressed on, or failed to respond to, at least one prior systemic therapy

4. Evaluable or measurable disease per RECIST 1.1

5. ECOG performance status of 0 or 1

6. In the dose expansion stage, patients with BRCA (breast carcinoma) mutation will be
enrolled. Patients with breast cancer, ovarian cancer and prostate cancer are
preferred.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inadequate haematologic and organ function, defined by the following (haematologic
parameters must be assessed greater than or equal to 14 days after a prior treatment,
if any):

1. Absolute neutrophil count <1500 cells/uL

2. Haemoglobin <9 g/dL

3. Total bilirubin >1.5 x the ULN, with documented liver metastases total bilirubin
>3 x the ULN .

4. AST and/or ALT >2.5 x the ULN, with documented liver metastases AST and/or ALT
levels > 5 x the ULN.

5. Serum creatinine > 1.5 x the ULN, or creatinine clearance < 50 mL/min based on a
documented 24-hour urine collection.

6. International normalized ratio (INR) > 1.5 x the ULN or activated partial
thromboplastin time (aPTT) >1.5 x the ULN The INR applies only to patients who do
not receive therapeutic anti-coagulation.

2. Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy,
radiotherapy within 4 weeks prior to initiation of study treatment with the following
exceptions:

1. Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists for prostate
cancer

2. Hormone-replacement therapy or oral contraceptives

3. Palliative radiation to bone metastases > 2 weeks prior to Day 1

3. Adverse events from prior anti-cancer therapy that have not resolved to CTCAE Grade
less than or equal to 1, except for alopecia

4. Clinical significant active infection

5. Known clinically significant history of liver disease, including viral or other
hepatitis, current alcohol abuse, or cirrhosis

6. Known human immunodeficiency virus infection

7. New York Heart Association (NYHA) Class II or greater congestive heart failure;
history of myocardial infarction or unstable angina within 6 months prior to Day 1;
history of stroke or transient ischemic attack within 6 months prior to Day 1

8. Active or untreated brain metastasis

9. Pregnant (positive pregnancy test) or lactating women

10. Male or female patients of child-producing potential unwilling to use double barrier
contraception: condoms, sponge, foams, jellies, diaphragm or intrauterine device
(IUD), contraceptives (oral, injectable or parenteral), implanon, or other avoidance
of pregnancy measures during the study and for 90 days after the last day of treatment

11. Inability to take oral medication, prior surgical procedures affecting absorption, or
active peptic ulcer disease

12. Inability to comply with study and follow-up procedures

13. Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that, in the investigator's opinion, gives reasonable suspicion of
a disease or condition that contraindicates the use of an investigational drug or that
may affect the interpretation of the results or renders the patient at high risk from
treatment complications.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/03/2021
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
St George Private Hospital - Kogarah
Recruitment hospital [3] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Impact Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 1, First-In-Human, open label study, trialing a new PARP (poly-ADP ribose
polymerase) inhibitor medication IMP4297 in participants with advanced solid tumour.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03507543
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter
Address 0 0
Epworth Medical Centre
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