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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 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.

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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."

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

FieldValue
Enrollment Target 133 participants
Start Date 2017-05-04
Est. Completion 2024-05-16
Phase Phase 1

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT03099174

The ClinicalTrials.gov registry entry for NCT03099174 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (92% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.