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Chemotherapy

Recombinant EphB4-HSA Fusion Protein for Pancreatic Cancer

Phase 1

Waitlist Available

Led By Anthony El-Khoueiry

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from start of treatment with recombinant ephb4-hsa fusion protein (start of 2nd course) to death for any cause, assessed up to 2 years

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of a new protein drug when given with standard chemotherapy drugs to treat patients with solid tumors that have spread and can't be cured or controlled with treatment.

Eligible Conditions

Pancreatic Cancer
Head and Neck Squamous Cell Carcinoma
Gallbladder Cancer
Non-Small Cell Lung Cancer
Cholangiocarcinoma
Pancreatic Adenocarcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from start of treatment with recombinant ephb4-hsa fusion protein (start of 2nd course) to death for any cause, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from start of treatment with recombinant ephb4-hsa fusion protein (start of 2nd course) to death for any cause, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from start of treatment with recombinant ephb4-hsa fusion protein (start of 2nd course) to death for any cause, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of overall response or SD

Incidence of toxicities, graded according to Common Terminology Criteria for Adverse Events version 4

Objective response using RECIST version 1.1

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C (sEphB4-HSA, cisplatin, gemcitabine hydrochloride)Experimental Treatment5 Interventions

Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, and 15 (beginning course 2), cisplatin IV over 120 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (sEphB4-HSA, docetaxel)Experimental Treatment4 Interventions

Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, and 15 (beginning course 2) and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group III: Arm A (sEphB4-HSA, nab-paclitaxel, gemcitabine hydrochloride)Experimental Treatment5 Interventions

Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, 15, and 22 (beginning course 2), paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

FDA approved

Albumin human

FDA approved

Docetaxel

FDA approved

Gemcitabine

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

906 Previous Clinical Trials

1,596,096 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,680 Previous Clinical Trials

40,928,458 Total Patients Enrolled

Vasgene Therapeutics, IncIndustry Sponsor

7 Previous Clinical Trials

245 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions commonly call for the treatment of Recombinant EphB4-HSA Fusion Protein?

"Recombinant EphB4-HSA Fusion Protein is prescribed to patients that have had prior adjuvant anthracycline therapy, and can be used to alleviate symptoms related to head maladies, hypoalbuminemia and neoplasm metastasis."

Answered by AI

Are there any vacancies on this clinical trial?

"At this point in time, no additional candidates are being accepted for the study posted on September 3rd 2015. However, if you're keen to explore other trials; 6219 studies recruiting participants with oral squamous cell carcinoma and 1752 clinical trials involving Recombinant EphB4-HSA Fusion Protein are actively accepting patients."

Answered by AI

Has the FDA authorized Recombinant EphB4-HSA Fusion Protein for widespread use?

"Due to its limited safety and efficacy data, Recombinant EphB4-HSA Fusion Protein received a score of 1 on the Power scale."

Answered by AI

How many participants have been enrolled to this trial thus far?

"Unfortunately, the trial is not presently accepting new patients. First posted on September 3rd 2015 and recently updated August 5th 2022, no more participants can be enrolled in this particular study at present. For those searching for other trials related to oral squamous cell carcinoma there are 6219 active studies while 1752 are recruiting patients for Recombinant EphB4-HSA Fusion Protein treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors

2015. "Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02495896.