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NCT03471663 · ClinicalTrials.gov registry record · Phase 1

A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer

A Phase 1 study of Breast Cancer, sponsored by InventisBio Co..

Completed
Registry status
Phase 1
Development phase
200
Enrollment target
15
Study locations

NCT03471663 is a Phase 1 study of Breast Cancer that has completed, run by InventisBio Co.. The registered enrollment target is 200 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 15 study locations across 12 states.

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The verdict

NCT03471663, a Phase 1 study of Breast Cancer, has completed, sponsored by InventisBio Co..

COMPLETED
Registry status
Phase 1
Development phase
200 participants
Enrollment target
15
Study locations

Study Summary

This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.

Conditions Studied

Breast Cancer

Interventions

  • DRUG palbociclib
  • DRUG D-0502

Study Locations (15)

Texas

  • Local Institution - Dallas
  • Local Institution - San Antonio
  • Local Institution - San Antonio
  • Local Institution - Tyler

California

  • Local Institution - Fresno

Colorado

  • Local Institution - Aurora

Connecticut

  • Local Institution - New Haven

Massachusetts

  • Local Institution - Boston

Oregon

  • Local Institution - Eugene

South Carolina

  • Local Institution - Greenville

Tennessee

  • Local Institution - Nashville

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2018-03-18
Est. Completion 2023-10-18
Phase Phase 1

Sponsor

InventisBio Co.

11 total trials

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What the Registry Record Tells You About NCT03471663

The ClinicalTrials.gov registry entry for NCT03471663 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The listed sponsor is InventisBio Co., which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which palbociclib is the first listed.

NCT03471663 reports 15 study locations spanning 12 distinct geographic areas - top geographies include Texas, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT03471663 about?

NCT03471663 is a clinical study titled "A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer". This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic E...

What is the current status of trial NCT03471663?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2018-03-18. Estimated completion is 2023-10-18.

What conditions does trial NCT03471663 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT03471663?

The interventions under investigation include: palbociclib (DRUG), D-0502 (DRUG).

Who is sponsoring clinical trial NCT03471663?

This trial is sponsored by InventisBio Co., which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03471663 being conducted?

This trial has 15 study locations across California, Colorado, Connecticut, Massachusetts, Oregon. 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.