Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy

NCT ID: NCT00419159

Last Updated: 2019-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-03-31

Brief 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Everolimus (RAD001) 70 mg/week

Group Type: EXPERIMENTAL

Everolimus (RAD001)

Intervention Type: DRUG

Everolimus was supplied in 5 mg tablets in blister packs.

Everolimus (RAD001) 10 mg/day

Group Type: EXPERIMENTAL

Everolimus (RAD001)

Intervention Type: DRUG

Everolimus was supplied in 5 mg tablets in blister packs.

Interventions

Everolimus (RAD001)

Everolimus was supplied in 5 mg tablets in blister packs.

Intervention Type: DRUG

Other Intervention Names

Afinitor; Zortress; Certican

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Nevada Cancer Institute

Las Vegas, Nevada, United States

Countries

United States

Related Links

http://www.NovartisClinicalTrials.com

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Other Identifiers

CRAD001C2241

Identifier Type: -

Identifier Source: org_study_id