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NCT02390427 · ClinicalTrials.gov registry record · Phase 1

Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer

A Phase 1 study of Metastatic Breast Cancer and Recurrent Breast Cancer, sponsored by Otto Metzger, MD.

Completed
Registry status
Phase 1
Development phase
68
Enrollment target
3
Study locations

NCT02390427 is a Phase 1 study of Metastatic Breast Cancer and Recurrent Breast Cancer that has completed, run by Otto Metzger, MD. The registered enrollment target is 68 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (67% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT02390427, a Phase 1 study of Metastatic Breast Cancer and Recurrent Breast Cancer, has completed, sponsored by Otto Metzger, MD.

COMPLETED
Registry status
Phase 1
Development phase
68 participants
Enrollment target
3
Study locations

Study Summary

This research study is a way of gaining new knowledge about the combination of Taselisib with other drugs in the treatment of metastatic breast cancer. Taselisib is an investigational drug which works by blocking a protein called PI3K (phosphoinositide 3-kinase) that helps cancer cells grow. This drug has been used in laboratory experiments and information from these studies suggests that this drug may help to prevent or slow the growth of cancer cells. The main purpose of this study is to find the appropriate dose of Taselisib to be used with other drugs in further clinical studies. This is an open-label, 3+3 dose-escalation phase Ib study to identify the Maximum Tolerated Dose(s) (MTD) and to identify the recommended phase 2 dose (RP2D) of Taselisib. This study will be conducted in 4 separate arms. (A-D).

Conditions Studied

Metastatic Breast Cancer Recurrent Breast Cancer

Interventions

  • DRUG Trastuzumab
  • DRUG Paclitaxel
  • DRUG Trastuzumab emtansine
  • DRUG Pertuzumab
  • DRUG Taselisib

Study Locations (3)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana Farber Cancer Institute - Boston

Tennessee

  • Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2015-04-20
Est. Completion 2024-07
Phase Phase 1

Sponsor

Otto Metzger, MD

1 total trials

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What the Registry Record Tells You About NCT02390427

The ClinicalTrials.gov registry entry for NCT02390427 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (67% lower). The listed sponsor is Otto Metzger, MD, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.

NCT02390427 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Tennessee.

Frequently Asked Questions

What is clinical trial NCT02390427 about?

NCT02390427 is a clinical study titled "Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer". This research study is a way of gaining new knowledge about the combination of Taselisib with other drugs in the treatment of metastatic breast cancer. Taselisib is an investigational drug which works by blocking a protein called PI3K (phosphoinositide 3-kinase) that helps cancer cells grow. This dr...

What is the current status of trial NCT02390427?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2015-04-20. Estimated completion is 2024-07.

What conditions does trial NCT02390427 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer, Recurrent Breast Cancer.

What interventions are being tested in trial NCT02390427?

The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), Trastuzumab emtansine (DRUG), Pertuzumab (DRUG), Taselisib (DRUG).

Who is sponsoring clinical trial NCT02390427?

This trial is sponsored by Otto Metzger, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02390427 being conducted?

This trial has 3 study locations across Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.