RAmucirumab Combined wIth Standard Nab-paclitaxel and Gemcitabine as First-line Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma

NCT03745430 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-05-24

No results posted yet for this study

Summary

RACING (RAmucirumab Combined wIth standard Nab-paclitaxel and Gemcitabine as first-line chemotherapy in patients with advanced pancreatic adenocarcinoma) trial is a Greek, investigator-initiated, single-arm, open-label phase Ib-II study. Patients with advanced cytologically or histologically proven pancreatic adenocarcinoma will be treated with a combination of Ramucirumab with Nab-paclitaxel and Gemcitabine (for a maximum of 8 cycles followed by Ramucirumab maintenance) until disease progression or excessive Adverse Events (AEs) or Investigator's decision or patient's refusal of further treatment or death, whichever comes first.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DRUG

Ramucirumab

8 mg/kg (days 1 and 15, q4w) until disease progression

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY
  • Celgene Corporation

    collaborator INDUSTRY
  • Hellenic Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • George Papaxoinis, MD · 2nd Medical Department, Agios Savvas Anticancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2022-06-17
Completion
2023-04-23

Countries

  • Greece

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745430 on ClinicalTrials.gov