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A Randomized, Double Blind Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma After Prior Chemotherapy

NCT01248403 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-01-29

No results posted yet for this study

Summary

Adult patients with gastric carcinoma which has progressed after initial treatment with a fluoropyrimidines-containing regimen will be treated with paclitaxel plus RAD001 or plus placebo. The hypothesis is that patients with RAD001 have significantly prolonged overall survival compared to patients who are treated with paclitaxel alone.

Conditions

  • Advanced Gastric Cancer
  • Esophagogastric Junction Cancer

Interventions

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 on day 1, day 8 and day 15 of every 28-day cycle.

DRUG

RAD001

RAD001 10mg (2 x5 mg tablets / day) d1-d28

Sponsors & Collaborators

  • Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Salah-Eddin Al-Batran, MD · Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2017-07-31
Completion
2019-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT01248403 on ClinicalTrials.gov