Ramucirumab + Somatostatin Analog for Carcinoid Tumor

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Antiplatelets, NSAIDs

Disqualifiers: Pancreatic tumors, Hypertension, Heart failure, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 28 days per cycle

43 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is evaluating the drug Ramucirumab as a possible treatment for Advanced, Progressive Carcinoid Tumors.

Research Team

Jennifer A Chan, MD MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults with advanced, progressive carcinoid tumors (excluding pancreatic neuroendocrine tumors) who have shown disease progression in the last year. Participants must have measurable disease, stable organ and marrow function, no major surgery or chemotherapy within 4 weeks prior to enrollment, and not be on certain medications like chronic antiplatelet therapy. Pregnant or breastfeeding women are excluded.

Inclusion Criteria

Your liver enzyme levels are not too high, unless you have cancer that has spread to your liver.

My cancer has worsened in the last year, shown by scans.

I can carry out all my usual activities without help.

Exclusion Criteria

Patients who are receiving any other investigational agents.

I have painful gallstones.

I have not had severe gastrointestinal bleeding in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ramucirumab in combination with Somatostatin Analog every 14 days in a 28-day cycle

28 days per cycle

1 visit every 14 days

Follow-up

Participants are monitored for progression-free survival and overall survival

23.5 months

Survival collected every 12 weeks

Treatment Details

Interventions

• Ramucirumab
• Somatostatin Analog

Trial Overview The trial is testing Ramucirumab combined with Somatostatin Analog therapy for treating advanced carcinoid tumors. It aims to evaluate the effectiveness of this drug combination in controlling tumor growth.

Participant Groups

Group I: Ramucirumab In Combination With Somatostatin Analog Experimental Treatment 2 Interventions

Patients will receive treatment with ramucirumab starting at a dose of 8 mg/kg intravenously every 14 days of a 28-day treatment cycle. Patients already receiving a somatostatin analog continued somatostatin analog therapy at their current dose. Patients not already receiving a somatostatin analog initiated treatment at an approved dose, according to institutional guidelines. Toxicity and adverse events will be examined in the first 10 patients who complete one cycle of therapy before expanding enrollment.

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

Approved in United States as Cyramza for:

• Gastric cancer
• Non-small cell lung cancer
• Colorectal cancer
• Hepatocellular carcinoma

Approved in European Union as Cyramza for:

• Gastric cancer
• Non-small cell lung cancer
• Colorectal cancer

Approved in Japan as Cyramza for:

• Gastric cancer
• Non-small cell lung cancer
• Colorectal cancer

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University