A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients with Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced solid tumours; Cancer - Breast; Cancer - Ovarian and primary peritoneal; Cancer - Prostate

• Registration Number: ACTRN12616000689471
• Lead Sponsor: IMPACT Therapeutics Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-26
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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 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):
a.Absolute neutrophil count <1500 cells/uL
b.Haemoglobin <9 g/dL
c.Total bilirubin >1.5 x the ULN, with documented liver metastases total bilirubin >3 x the ULN .
d.AST and/or ALT >2.5 x the ULN, with documented liver metastases AST and/or ALT levels > 5 x the ULN.
e.Serum creatinine > 1.5 x the ULN, or creatinine clearance < 50 mL/min based on a documented 24-hour urine collection.
f.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:
a.Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists for prostate cancer
b.Hormone-replacement therapy or oral contraceptives
c.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

• Study Type: Interventional
• Study Design: Not specified