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NCT03099174 · ClinicalTrials.gov registry record · Phase 1
This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer
A Phase 1 study of Neoplasms and Breast Neoplasms, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 133
- Enrollment target
- 20
- Study locations
NCT03099174: Completed Phase 1 study of Neoplasms and Breast Neoplasms, sponsored by Boehringer Ingelheim.
NCT03099174 is a Phase 1 study of Neoplasms and Breast Neoplasms that has completed, run by Boehringer Ingelheim. The registered enrollment target is 133 participants, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03099174, a Phase 1 study of Neoplasms and Breast Neoplasms, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 133 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: * Xentuzumab in combination with abemaciclib * Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in participants with lung and breast cancer. Participants can stay in the study as long as they benefit from and can tolerate treatment. All participants get xentuzumab infusions and abemaciclib tablets. Participants who have breast cancer get different types of hormonal therapies in addition to xentuzumab and abemaciclib. For all participants, the size of the tumour is measured regularly. Doctors also regularly check the general health of the participants."
Primary Outcome
MTD during the MTD evaluation period (the first 28 day cycle). The MTD is defined as the highest dose with \<25% risk of the true Dose limiting toxicity (DLT) rate \>33%. DLT: adverse event or laboratory abnormality which 1) is related, probably related or possibly related to study drug and 2) meets any of the following criteria, unless that toxicity can be attributed to cancer progression or to identified etiology: CTCAE grade (Gr). 3+ hyperglycaemia (\>48 hours), Gr. 4 hyperglycaemia, hemato
Conditions Studied
Interventions
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Fulvestrant
- DRUG Abemaciclib
- DRUG Xentuzumab
Study Locations (20)
Other
- Herlev and Gentofte Hospital - Herlev
- Copenhagen University Hospital, Rigshospitalet - København Ø
- Docrates Clinic - Helsinki
- HUCH Comprehensive Cancer Center, building 2 - Helsinki
- Tampere University Hospital - Tampere
- CRST - Clinical Research Services Turku - Turku
- HOP Jean Minjoz - Besançon
- INS Paoli-Calmettes - Marseille
- INS Curie - Paris
- Ctr Cario - Plerin Sur Mer
- Aichi Cancer Center Hospital - Aichi, Nagoya
- National Cancer Center Hospital East - Chiba, Kashiwa
- Tokai University Hospital - Kanagawa, Isehara
- National Cancer Center Hospital - Tokyo, Chuo-ku
California
- University of California Los Angeles - Santa Monica
Connecticut
- Yale University School of Medicine - New Haven
Florida
- University of Miami - Miami
Minnesota
- University of Minnesota - Minneapolis
Nevada
- Comprehensive Cancer Centers of Nevada - Las Vegas
North Carolina
- The University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2017-05-04 |
| Est. Completion | 2024-05-16 |
| Phase | Phase 1 |
What the finished NCT03099174 record still lists
NCT03099174 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Anastrozole is the first listed.
NCT03099174 names 20 study sites across 7 states, led by Other, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03099174 about?
NCT03099174 is a clinical study titled "This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer". This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: * Xentuzumab in combination with abemaciclib * Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in...
What is the current status of trial NCT03099174?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 133 participants. The study started on 2017-05-04. Estimated completion is 2024-05-16.
What conditions does trial NCT03099174 study?
This clinical trial studies the following conditions: Neoplasms, Breast Neoplasms.
What interventions are being tested in trial NCT03099174?
The interventions under investigation include: Anastrozole (DRUG), Letrozole (DRUG), Fulvestrant (DRUG), Abemaciclib (DRUG), Xentuzumab (DRUG).
Who is sponsoring clinical trial NCT03099174?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03099174 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Minnesota, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03099174's enrollment target sits among peer trials
133 62nd of 158 higher than 97 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
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