The Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors
A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors
1 other identifier
interventional
39
1 country
3
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2017
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2017
CompletedFirst Submitted
Initial submission to the registry
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
April 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2021
CompletedMarch 30, 2021
March 1, 2021
3.6 years
January 8, 2018
March 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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 Outcomes (12)
Area Under Curve [AUClast, AUCINF and AUCtau]
Within 7 days after firstly single dose administrated
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)
Maximum plasma concentration (Cmax)
Within 7 days after firstly single dose administrated
Maximum plasma concentration (Cmax)
Within 16 days after first dose administrated in multiple dose cycle 1 (total 21 days in one cycle)
Time at which Cmax occurred (Tmax)
Within 7 days after firstly single dose administrated
- +7 more secondary outcomes
Study Arms (1)
IMP4297
EXPERIMENTALInterventions
The dose levels will be escalated following a modified 3+3 dose escalation scheme.
Eligibility Criteria
You may qualify if:
- Signed Informed Consent Form
- Age greater than or equal to 18 years
- Histologically or cytologically documented, incurable, advanced solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy
- Evaluable or measurable disease per RECIST 1.1
- ECOG performance status of 0 or 1
- 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.
You may not qualify if:
- 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):
- Absolute neutrophil count \<1500 cells/uL
- Haemoglobin \<9 g/dL
- Total bilirubin \>1.5 x the ULN, with documented liver metastases total bilirubin \>3 x the ULN .
- AST and/or ALT \>2.5 x the ULN, with documented liver metastases AST and/or ALT levels \> 5 x the ULN.
- Serum creatinine \> 1.5 x the ULN, or creatinine clearance \< 50 mL/min based on a documented 24-hour urine collection.
- 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.
- Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, radiotherapy within 4 weeks prior to initiation of study treatment with the following exceptions:
- Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists for prostate cancer
- Hormone-replacement therapy or oral contraceptives
- Palliative radiation to bone metastases \> 2 weeks prior to Day 1
- Adverse events from prior anti-cancer therapy that have not resolved to CTCAE Grade less than or equal to 1, except for alopecia
- Clinical significant active infection
- Known clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Known human immunodeficiency virus infection
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
St George Private Hospital
Kogarah, New South Wales, Australia
Nucleus Network
Melbourne, Victoria, 3004, Australia
Related Publications (1)
Gao B, Voskoboynik M, Cooper A, Wilkinson K, Hoon S, Hsieh CY, Cai S, Tian YE, Bao J, Ma N, Wang C, Zhang M, Li B, Guo M, Zhou R, Wang X, Xu C, de Souza P. A phase 1 dose-escalation study of the poly(ADP-ribose) polymerase inhibitor senaparib in Australian patients with advanced solid tumors. Cancer. 2023 Apr 1;129(7):1041-1050. doi: 10.1002/cncr.34662. Epub 2023 Jan 31.
PMID: 36718624DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Lickliter
Epworth Medical Centre
- PRINCIPAL INVESTIGATOR
Paul Souza
St George Private Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2018
First Posted
April 25, 2018
Study Start
February 3, 2017
Primary Completion
September 24, 2020
Study Completion
March 17, 2021
Last Updated
March 30, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share