Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Everolimus (RAD001)
Intervention description: Everolimus was supplied in 5 mg tablets in blister packs.
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colorectal cancer; metastatic colorectal adenocarcinoma; anti-EGFR antibody

Summary:

      To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day)
      everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite
      prior treatment with targeted therapy and chemotherapy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age ≥ 18 years old.

          -  Patients with metastatic colorectal cancer (CRC).

          -  Patients must have sufficient and obtainable tumor tissue for biomarker analysis from
             original surgical resection.

          -  Patients with documented disease progression within 6 months of their most recent dose
             of chemotherapeutic regimens.

          -  Patients with at least one measurable lesion.

          -  Adequate bone marrow function.

          -  Adequate liver function.

          -  Adequate renal function.

          -  Patients with a life expectancy of > 3 months.

          -  Patients with a World Health Organization (WHO) performance status of 0, 1, or 2.

          -  Women of childbearing potential must have had a negative serum pregnancy test 72 hours
             prior to the administration of the first study treatment.

          -  Patients who give a written informed consent obtained according to local guidelines.

        Exclusion criteria:

          -  Patients currently receiving anti-cancer agents or who have received these within 4
             weeks prior to study entry.

          -  Patients who have previously received RAD001.

          -  Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus,
             temsirolimus) or to its excipients.

          -  Chronic treatment with steroids or another immunosuppressive agent.

          -  Patients with untreated central nervous system (CNS) metastases or neurologically
             unstable CNS metastases.

          -  HIV seropositivity.

          -  Patients with an active, bleeding diathesis. Patients may use enoxaparin.

          -  Patients who have any severe and/or uncontrolled medical conditions or other
             conditions that could affect their participation in the study.

          -  Patients who have a history of another primary malignancy < 3 years, with the
             exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.

          -  Female patients who are pregnant or breast feeding, or adults of reproductive
             potential who are not using effective birth control methods.

          -  Patients who are using other investigational agents or who had received
             investigational drugs ≤ 4 weeks prior to first study treatment.

          -  Patients unwilling to or unable to comply with the protocol.

        Other protocol defined inclusion/exclusion criteria may apply