Ramucirumab for Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hospital General Universitario de Elche, Alicante, Spain
Adenocarcinoma+5 More
Ramucirumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)

See full description

Eligible Conditions

  • Adenocarcinoma
  • Malignant Neoplasm of Stomach
  • Adenocarcinoma of the Stomach
  • Adenocarcinomas of the Gastroesophageal Junction

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Adenocarcinoma

Study Objectives

This trial is evaluating whether Ramucirumab will improve 2 primary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of Last randomized patient on study at least 16 weeks.

Month 36
Phase 3
Week 16
Phase 2

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Adenocarcinoma

Trial Design

4 Treatment Groups

Phase 2 - Arm B
1 of 4
Phase 3 - Arm B
1 of 4
Phase 3 - Arm A
1 of 4
Phase 2 - Arm A
1 of 4
Active Control
Experimental Treatment

This trial requires 450 total participants across 4 different treatment groups

This trial involves 4 different treatments. Ramucirumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Phase 3 - Arm AEvorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 2 - Arm AEvorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 2 - Arm BTrastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 3 - Arm BRamucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
FDA approved
Trastuzumab
FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of randomization to the date of death (due to any cause), up to 36 months postdose
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from the date of randomization to the date of death (due to any cause), up to 36 months postdose for reporting.

Closest Location

Vanderbilt University Medical Center - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
HER2-overexpressing advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after a prior HER2-directed agent and fluoropyrimidine- or platinum-containing chemotherapy (2nd-line or 3rd-line)
Adequate Bone Marrow Function.
Adequate Renal & Liver Function.
Adequate Performance Status

Patient Q&A Section

Can cancer of stomach be cured?

"Most gastric cancers will recur in the liver or the lungs. Most gastric cancers are in situ at the time of diagnosing, thus curing and achieving optimal organ preservation cannot be achieved." - Anonymous Online Contributor

Unverified Answer

How many people get cancer of stomach a year in the United States?

"There will be more than 40,000 new cases of stomach cancer in the USA in 2019, and more than 21,000 people will die from stomach cancer that year." - Anonymous Online Contributor

Unverified Answer

What causes cancer of stomach?

"One third of the patients were smokers. More than 85% of the patients who developed stomach cancer in this study were older than 60 years of age. The patients with stomach cancer had large volume of alcohol consumption, Helicobacter pylori infection, and NSAID consuming." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer of stomach?

"Gastric cancer causes many symptoms, which depend on the site and the aggressiveness of the tumor. These symptoms are classified into local and distant metastases. Other causes of cancer pain include other metastatic cancer, congestive heart failure, and chronic kidney disease. These signs can also occur in the absence of a true primary tumor." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer of stomach?

"Treatment options are very variable between nations (e.g., surgery versus radiation versus chemoradiation), but overall this treatment paradigm involves chemotherapy, radiation therapy, or surgery followed by adjuvant treatment with gemcitabine in cases of gastric cancer." - Anonymous Online Contributor

Unverified Answer

What is cancer of stomach?

"Cancer of stomach is a devastating disease with heavy morbidity and deaths in the developing world, where [gastric cancer](https://www.withpower.com/clinical-trials/gastric-cancer)s are the most common type of stomach cancer." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in evorpacept (alx148) for therapeutic use?

"There is much clinical support for alx148 based on results from multiple clinical trials. The development of alx148 is ongoing and additional therapeutic properties of alx148 are being evaluated including a new indication in the treatment of acute heart failure based on alx148's activity and positive results from the ALX-037 pivotal study." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of evorpacept (alx148)?

"The main common side effect is swelling of the arm or leg. Other common side effects include itchiness, fever, vomiting, and headache. People who have taken evorpacept for a longer amount of time had a higher frequency of nausea." - Anonymous Online Contributor

Unverified Answer

Is evorpacept (alx148) safe for people?

"Results showed, from one of the first safety trials that included patients who have undergone malignancy treatment, that Alx148 is well tolerated for patients with a variety of prior malignancy. Alx148 provided benefit for patients with recurrent or second primary cancers, especially if used in conjunction with corticosteroids. In this sense, Alx148 is a novel option to alleviate some of the troubling symptoms of cancer survivors. It achieves these benefits without causing toxicity at doses that cause few side effects, and it achieves effectiveness without compromising quality of life." - Anonymous Online Contributor

Unverified Answer

Has evorpacept (alx148) proven to be more effective than a placebo?

"No improvement in survival time of patients with metastatic cancer was measured by evorpacept. In fact, the median survival time was 6.9 months in patients given placebo compared to 6.3 months in patients taking evorpacept." - Anonymous Online Contributor

Unverified Answer

Does evorpacept (alx148) improve quality of life for those with cancer of stomach?

"ALX148 had no influence on any of the measured EORTC QL assessments for patients with cancer of the stomach. The study has shown the difficulty in determining relevant, meaningful changes in QL that will aid health professionals when evaluating therapies." - Anonymous Online Contributor

Unverified Answer

How serious can cancer of stomach be?

"In comparison to other types of cancers of the gastrointestinal tract (e.g., colon cancer, gastric cancer), cancer of the stomach is less common and often metastasizing. Most common sites of distant metastasis in stomach cancer is to lymph node. Survival time is generally short, except for the case of the early-stage N2-3 gastric cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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