Active — Not RecruitingPhase 1

Selumetinib and Olaparib in Solid Tumors

United States90 participantsStarted 2017-08-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
✓. Age \>/= 18 years at time of study entry
✓. Patients with advanced cancer that is refractory to standard therapy, or that has either relapsed after standard therapy or has no standard therapy that increases survival by at least three months.
✓. Patients may have unlimited prior chemotherapy treatments.
✓. For dose escalation phase, patients may have evaluable or measurable disease. For ovarian cancer, if no measurable disease is present, patients should have assessable disease such as pleural effusion, ascites, with CA-125 GCIG criteria.
✓. For dose expansion phase, patients must have at least one site of measurable disease as defined by RECIST criteria (Version 1.1).
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.03) \</= Grade 1 at the time of screening (except alopecia).

Exclusion criteria

What they're measuring

Maximum Tolerated Dose (MTD) for Combination of Selumetinib and Olaparib in Participants with Advanced or Recurrent Solid Tumors

Timeframe: 28 days

Trial details

NCT IDNCT03162627

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-30

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