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Paclitaxel

Everolimus

Albumin-Bound Paclitaxel

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

+ Placebo (2 tablets / day) d1-d28

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

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

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

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

RAD001

Salah-Eddin Al-Batran, MD

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.

This is a randomized, double-blind, phase III two-arm multi-center study aiming at estimating the relative efficacy of the combination of RAD001 and paclitaxel versus that of paclitaxel alone as second-, third- or fourth-line treatment in terms of hazard ratio of overall survival in patients with gastric cancer who have relapsed after one treatment regimen containing a fluoropyrimidine (e.g., 5-FU, S-1, capecitabine and other 5-FU prodrugs or derivatives). Patients will be randomized in a 1:1 ratio for a total of 240 patients per treatment arm. Randomization will be stratified according to performance status (0-1 versus 2), prior taxan use (yes vs. no) and treatment line (2nd versus 3rd/4th line).

Study treatment will be continued until progression or intolerable toxicity. Patients will be seen at baseline/screening, and weekly for paclitaxel administration and safety assessment until disease progression or discontinuation of trial therapy for other reasons. Radiological tumor assessment will be performed every second cycle (every 8 weeks) or earlier if clinically indicated. Post-study follow-up will be completed every 8 weeks for survival.

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

A Randomized, Double-blind, Multi-center Phase III Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma Who Have Progressed After Therapy With a Fluoropyrimidine-containing Regimen

Krankenhaus Nordwest

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Randomized, Double Blind Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma After Prior Chemotherapy	NCT01248403	Advanced Gastri... Esophagogastric...	Paclitaxel RAD001	18 Years -	Krankenhaus Nordwest
A Randomized, Double Blind Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma After Prior Chemotherapy	NCT01248403	Advanced Gastri... Esophagogastric...	Paclitaxel RAD001	18 Years -	Krankenhaus Nordwest

Spots Global Cancer Trial Database for advanced gastric or esophagogastric junction cancer