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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: Active Phase 1 study of Malignant Neoplasm of Breast and Malignant Neoplasms of Female Genital Organs, sponsored by M.D. Anderson Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD defined by dose limiting toxicities (DLTs) that occur during the first 4 weeks of therapy and are related to the study medications. Grading of DLTs follow the guidelines provided in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Conditions Studied
Interventions
- DRUG Olaparib
- DRUG Selumetinib
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2017-08-04 |
| Est. Completion | 2026-08-30 |
| Phase | Phase 1 |
What the registry record for NCT03162627 still lists
NCT03162627 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 53-participant average among 10 other Malignant Neoplasm of Breast trials with a reported enrollment target (70% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03162627's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Neoplasm of Breast trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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