Selumetinib + Olaparib for Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByShannon Westin, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with advanced or recurrent solid tumors, including various cancers like breast, thyroid, and cervical cancer. Participants must have a life expectancy of at least 16 weeks and be able to follow the study protocol. Women should not be pregnant or breastfeeding and must use effective contraception; men also need to use condoms. Patients should have adequate organ function and may have had any number of prior chemotherapy treatments but must be recovered from major surgeries or previous treatment side effects.

Inclusion Criteria

My side effects from previous treatments are mild, except for hair loss.

I am fully active or restricted in physically strenuous activity but can do light work.

I am postmenopausal or cannot become pregnant.

I am using two effective birth control methods.

I will use a condom during and for 3 months after treatment if my partner could get pregnant.

I am 18 years old or older.

Exclusion Criteria

I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 3 weeks.

I am currently taking certain medications.

I have had cancer before, but it fits the exceptions listed.

I am currently experiencing symptoms of lung inflammation.

I cannot swallow pills or have a stomach condition that affects medication absorption.

I have not taken MEK inhibitors for my condition.

I have been diagnosed with or show signs of myelodysplastic syndrome or acute myeloid leukemia.

I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using birth control.

My heart condition fits the specified criteria.

I have had a bone marrow or double cord blood transplant.

I am not using other cancer treatments or live vaccines while on the study medication.

I do not have any severe or uncontrolled illnesses.

I don't have lasting side effects from cancer treatment, except for hair loss.

I am not allergic to selumetinib, olaparib, or similar medications.

Participant Groups

The trial is testing Selumetinib in combination with Olaparib for treating advanced solid tumors over two phases: finding the highest tolerable dose (Phase 1) and then seeing if that dose can control the cancer (Phase 2). Selumetinib isn't FDA approved yet; it's being researched. Olaparib is approved for ovarian cancer with specific genetic mutations but its combination with Selumetinib is investigational.

5Treatment groups

Experimental Treatment

Group I: Solid Tumors that Harbor Somatic RPAExperimental Treatment2 Interventions

Dose Expansion Phase: Selumetinib + Olaparib taken at the maximum tolerated dose from Dose Escalation Phase.

Group II: Selumetinib + OlaparibExperimental Treatment2 Interventions

Dose Escalation Phase: Participants take both Selumetinib and Olaparib by mouth 2 times each day, about 12 hours apart at the Starting Dose Level. Treatment cycle is 28 days. When maximum tolerated dose reached, Dose Expansion Phase begins.

Group III: Ovarian Cancer-Progression-prior PARP TreatmentExperimental Treatment2 Interventions

Dose Expansion Phase: Selumetinib + Olaparib taken at the maximum tolerated dose from Dose Escalation Phase.

Group IV: Ovarian Cancer with RPAExperimental Treatment2 Interventions

Dose Expansion Phase: Selumetinib + Olaparib taken at the maximum tolerated dose from Dose Escalation Phase.

Group V: Endometrial Cancer with RPAExperimental Treatment2 Interventions

Dose Expansion Phase: Selumetinib + Olaparib taken at the maximum tolerated dose from Dose Escalation Phase.

Olaparib is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Lynparza for: