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NCT04434482 · ClinicalTrials.gov registry record · Phase 1
IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer
A Phase 1 study of Small-cell Lung Cancer and Advanced Solid Tumours, sponsored by Impact Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 20
- Study locations
NCT04434482: Completed Phase 1 study of Small-cell Lung Cancer and Advanced Solid Tumours, sponsored by Impact Therapeutics.
NCT04434482 is a Phase 1 study of Small-cell Lung Cancer and Advanced Solid Tumours that has completed, run by Impact Therapeutics. The registered enrollment target is 59 participants, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04434482, a Phase 1 study of Small-cell Lung Cancer and Advanced Solid Tumours, has completed, sponsored by Impact Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, multi-center, dose-escalation and dose-expansion phase I study to evaluate the safety, tolerability, PK characteristics and anti-tumor activity of PARP inhibitor IMP4297 and temozolomide combination therapy in patients with advanced solid tumors and with ES-SCLC who develops disease progression after 1L platinum-based regimen.
Primary Outcome
TEAEs, vital signs, physical examinations, electrocardiogram (ECG), laboratory tests (including serum chemistry, hematology, and urinalysis, coagulation), etc.
Conditions Studied
Interventions
- DRUG IMP4297(senaparib)
Study Locations (20)
Other
- Beijing Cancer Hospital - Beijing
- Jilin Cancer Hospital - Jilin
- Fudan University Shanghai Cancer Center - Shanghai
- Hubei Cancer Hospital - Wuhan
- Chungbuk National University Hospital - Cheongju-si
- The Catholic university of Korea, st. Vincent's Hospital - Gyeonggi-do
- Yonsei university health system, Severance Hospital - Seoul
- Asan Medical Center - Seoul
- China Medical University Hospital - Taichung
- National Cheng Kung University Hospital - Tainan
- Chi Mei Medical Center - Tainan
- National Taiwan University Hospital - Taipei
New South Wales
- Border Medical Oncology - Albury
- Blacktown Hospital - Blacktown
- Orange Hospital - Orange
Ohio
- Gabrail Cancer Researh Center - Canton
- Mark H. Zangmeister Center - Columbus
Illinois
- GenHarp Clinical Solutions - Evergreen Park
Tennessee
- Sarah Cannon Research Institute - Tennessee Oncology - Tennessee City
Victoria
- Peninsula Health Frankston Hospital - Frankston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2020-08-07 |
| Est. Completion | 2024-04-29 |
| Phase | Phase 1 |
What the finished NCT04434482 record still lists
NCT04434482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which IMP4297(senaparib) is the first listed.
NCT04434482 names 20 study sites across 6 states, led by Other, New South Wales, Ohio.
Frequently Asked Questions
What is clinical trial NCT04434482 about?
NCT04434482 is a clinical study titled "IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer". This is an open-label, multi-center, dose-escalation and dose-expansion phase I study to evaluate the safety, tolerability, PK characteristics and anti-tumor activity of PARP inhibitor IMP4297 and temozolomide combination therapy in patients with advanced solid tumors and with ES-SCLC who develops d...
What is the current status of trial NCT04434482?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2020-08-07. Estimated completion is 2024-04-29.
What conditions does trial NCT04434482 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer, Advanced Solid Tumours.
What interventions are being tested in trial NCT04434482?
The interventions under investigation include: IMP4297(senaparib) (DRUG).
Who is sponsoring clinical trial NCT04434482?
This trial is sponsored by Impact Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04434482 being conducted?
This trial has 20 study locations across Illinois, Ohio, Tennessee, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04434482's enrollment target sits among peer trials
59 48th of 79 higher than 32 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small-cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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