Breast Cancer Clinical Trial
Official title:
A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors
Verified date | March 2021 |
Source | Impact Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | March 17, 2021 |
Est. primary completion date | September 24, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Blacktown Hospital | Blacktown | New South Wales |
Australia | St George Private Hospital | Kogarah | New South Wales |
Australia | Nucleus Network | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Impact Therapeutics, Inc. |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The AEs (adverse event) of single and multiple doses of IMP4297 administered to participants with advanced solid tumors. | Evaluate the TEAE (treatment-emergent adverse event) of IMP4297 | Each visit after IMP4297 administrated (through study completion, an average of 10 months) | |
Primary | The maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLTs) of IMP4297. | Evaluate DLT and determine the MTD | Within 28 days after IMP4297 administrated | |
Secondary | Area Under Curve [AUClast, AUCINF and AUCtau] | Within 7 days after firstly single dose administrated | ||
Secondary | Area Under Curve [AUClast, AUCINF and AUCtau] | Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle) | ||
Secondary | Maximum plasma concentration (Cmax) | Within 7 days after firstly single dose administrated | ||
Secondary | Maximum plasma concentration (Cmax) | Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle) | ||
Secondary | Time at which Cmax occurred (Tmax) | Within 7 days after firstly single dose administrated | ||
Secondary | Time at which Cmax occurred (Tmax) | Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle) | ||
Secondary | Trough Concentrations (Ctrough) | Within 7 days after firstly single dose administrated | ||
Secondary | Trough Concentrations (Ctrough) | Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle) | ||
Secondary | Clearance (CL/F) | Within 7 days after firstly single dose administrated | ||
Secondary | Clearance (CL/F) | Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle) | ||
Secondary | Volume of distribution (Vd/F) | Within 7 days after firstly single dose administrated | ||
Secondary | Volume of distribution (Vd/F) | Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle) |
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