Study with a chemotherapy of paclitaxel with or without RAD001 in patients with gastric cancer after progressio

Phase 1

• Conditions: advanced (i.e. inoperable, recurrent or metastatic) gastric cancer or adenocarcinoma of the esophagogastric junction; MedDRA version: 18.0Level: PTClassification code 10001150Term: Adenocarcinoma gastricSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.0Level: LLTClassification code 10026104Term: Malignant neoplasm of lower third of esophagusSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-018092-14-DE
• Lead Sponsor: Krankenhaus Nordwest GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-27
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Male or female patients = 18 years old
Histologically or cytologically confirmed and documented gastric adenocarcinoma or adenocarcinoma of the esophagogastric junction, if they have advanced disease (inoperable, recurrent or metastatic disease).
Documented progressive disease during/after one or, two or three prior treatments containing 5FU/Platinum and/or its precursors or derivatives in the palliative setting. Neoadjuvant/adjuvant treatment is not counted, unless progression occurs < 6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one line.
At least one measurable or evaluable lesion by RECIST as determined by Computed Tomography (CT) Scan or Magnetic Resonance Imaging (MRI)
ECOG performance status of 0, 1 or 2
adequate liver function
adequate bone marrow function
adequate renal function
adequate contraception
signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

Current treatment with any anti cancer therapy or treatment with anti cancer therapy = 2 weeks prior to study treatment start unless rapidly progressing disease is measured
Prior treatment with RAD001
Known hypersensitivity to RAD001 (everolimus) or to its excipients, or to other rapamycins (e.g. sirolimus, temsirolimus)
Known prior history of hypersensitivity to paclitaxel
Paclitaxel refractory disease, which is defined as a disease progression within 12 weeks or less of last administration of paclitaxel based treatment in any treatment line
Chronic treatment with steroids (except for oral, topical or local injection) or another immunosuppressive agent
Major surgery = 2 weeks prior to starting study treatment or patients who have not recovered from such therapy
Lack of resolution of all acute toxic effects (excluding alopecia) of prior chemotherapy, prior radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade = 1. Note: Neuropathy due to prior chemotherapy is allowed.
Unstable CNS disease
Known history of HIV seropositivity (HIV testing is not mandatory) or Hepatitis B or C.
Active, bleeding diathesis or on oral anti-vitamin K medication (except low dose warfarin, as long as the INR is <= 2.0)
Any other severe and/or uncontrolled medical conditions
Participation in other interventional clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified