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NCT03162627 · ClinicalTrials.gov registry record · Phase 1

Selumetinib and Olaparib in Solid Tumors

A Phase 1 study of Malignant Neoplasm of Breast and Malignant Neoplasms of Female Genital Organs, sponsored by M.D. Anderson Cancer Center.

Active
Registry status
Phase 1
Development phase
90
Enrollment target
1
Study location

NCT03162627 is a Phase 1 study of Malignant Neoplasm of Breast and Malignant Neoplasms of Female Genital Organs that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 90 participants, above the 53-participant average among 10 other Malignant Neoplasm of Breast trials with a reported enrollment target (70% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT03162627, a Phase 1 study of Malignant Neoplasm of Breast and Malignant Neoplasms of Female Genital Organs, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
90 participants
Enrollment target
1
Study location

Study Summary

This study has 2 phases: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 of this clinical research study is to find the highest tolerable dose combination of selumetinib and olaparib that can be given to patients who have solid tumors that are advanced or recurrent (has returned after treatment). The goal of Phase 2 is to learn if the highest tolerable dose combination found in Phase 1 can help to control advanced or recurrent solid tumors. The safety of the study drug combination will also be studied in both parts. This is an investigational study. Selumetinib is not FDA approved or commercially available. It is currently being used for research purposes only. Olaparib is FDA approved and commercially available for the treatment of ovarian cancer that has a certain type of genetic mutation (change). It is considered investigational to use selumetinib in combination with olaparib to treat advanced or recurrent cancer. The study doctor can explain how the study drugs are designed to work. Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions Studied

Malignant Neoplasm of Breast Malignant Neoplasms of Female Genital Organs Malignant Neoplasms of Male Genital Organs Malignant Neoplasms of Thyroid and Other Endocrine Glands Malignant Neoplasms of Digestive Organs

Interventions

  • DRUG Olaparib
  • DRUG Selumetinib

Study Locations (1)

Texas

  • University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2017-08-04
Est. Completion 2026-08-30
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03162627

The ClinicalTrials.gov registry entry for NCT03162627 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 53-participant average among 10 other Malignant Neoplasm of Breast trials with a reported enrollment target (70% higher). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

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

NCT03162627 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT03162627 about?

NCT03162627 is a clinical study titled "Selumetinib and Olaparib in Solid Tumors". This study has 2 phases: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 of this clinical research study is to find the highest tolerable dose combination of selumetinib and olaparib that can be given to patients who have solid tumors that are advanced or recurrent (has ...

What is the current status of trial NCT03162627?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2017-08-04. Estimated completion is 2026-08-30.

What conditions does trial NCT03162627 study?

This clinical trial studies the following conditions: Malignant Neoplasm of Breast, Malignant Neoplasms of Female Genital Organs, Malignant Neoplasms of Male Genital Organs, Malignant Neoplasms of Thyroid and Other Endocrine Glands, Malignant Neoplasms of Digestive Organs.

What interventions are being tested in trial NCT03162627?

The interventions under investigation include: Olaparib (DRUG), Selumetinib (DRUG).

Who is sponsoring clinical trial NCT03162627?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03162627 being conducted?

This trial has 1 study location across Texas. 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.