Olaparib + Ramucirumab for Stomach or Esophageal Cancer

Recruiting at 34 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Cancer Institute (NCI)

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: Ongoing until disease progression or unacceptable toxicity

55 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of olaparib when given together with ramucirumab and how well they work in treating patients with gastric or gastroesophageal junction cancer that has spread to other places in the body (metastatic), has come back (recurrent), or cannot be removed by surgery (unresectable). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and ramucirumab may work better in treating patients with gastric or gastroesophageal junction cancer compared to ramucirumab and paclitaxel (a chemotherapy drug) or ramucirumab alone.

Research Team

Michael Cecchini

Principal Investigator

Yale University Cancer Center LAO

Eligibility Criteria

This trial is for adults with advanced gastric or gastroesophageal junction cancer that has spread and can't be surgically removed. Participants must have a life expectancy of at least 16 weeks, not have used certain drugs like ramucirumab or PARP inhibitors before, and should be able to take oral medications. They cannot join if they've had recent major surgery, uncontrolled medical conditions, known allergies to the study drugs, active infections including hepatitis B/C, other cancers, or are pregnant/breastfeeding.

Inclusion Criteria

Patient has a life expectancy of >= 16 weeks

I have agreed to participate in genetic research.

Willingness to undergo a biopsy prior to treatment, an on treatment biopsy at week 16 is optional if felt to be safe in the opinion of the investigator

Exclusion Criteria

I have had signs or symptoms of a bowel blockage in the last month.

I am allergic to medications similar to olaparib or ramucirumab.

I have had a bone marrow or cord blood transplant in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive olaparib orally twice daily and ramucirumab intravenously every 14 days

Ongoing until disease progression or unacceptable toxicity

Every 14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks initially, then every 6 weeks if no progression, or every 3 months if progression

Initial follow-up at 4 weeks, then every 6 weeks or 3 months

Treatment Details

Interventions

• Olaparib
• Ramucirumab

Trial Overview The trial is testing the combination of two drugs: Olaparib and Ramucirumab. Olaparib blocks enzymes needed for tumor cell growth while Ramucirumab helps the immune system attack cancer cells and prevents them from growing/spreading. The goal is to see if this combo works better than current treatments involving just Ramucirumab or chemotherapy.

Participant Groups

Group I: Treatment (olaparib, ramucirumab) Experimental Treatment 2 Interventions

Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

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

Approved in European Union as Lynparza for:

• Breast cancer
• Ovarian cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer
• Endometrial cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+