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Selumetinib and Olaparib in Solid Tumors

NCT03162627 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-15

No results posted yet for this 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

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

Interventions

DRUG

Selumetinib

Dose Escalation Phase Starting Dose: 50 mg by mouth twice a day on Days 1-28. Dose Expansion Phase Starting Dose: Maximum tolerated dose from Dose Escalation Phase.

DRUG

Olaparib

Dose Escalation Phase Starting Dose: 150 mg by mouth twice a day on Days 1-28. Dose Expansion Phase Starting Dose: Maximum tolerated dose from Dose Escalation Phase.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Shannon Westin, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-04
Primary Completion
2026-08-30
Completion
2026-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03162627 on ClinicalTrials.gov