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COMPLETEDPHASE2

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

A Single Arm, Multicenter Phase II Study of Everolimus in Patients With Metastatic Colorectal Adenocarcinoma Whose Cancer Has Progressed Despite Prior Therapy With an Anti-EGFR Antibody (if Appropriate), Bevacizumab, Fluoropyrimidine, Oxaliplatin, and Irinotecan-based Regimens

NCT00419159•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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.
+2 more criteria

Locations (1)

Nevada Cancer Institute

Las Vegas, Nevada, United States

Key Dates

Start Date

December 1, 2006

Primary Completion Date

March 1, 2009

Completion Date

March 1, 2009

Last Updated

April 23, 2019

Enrollment

199

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

Everolimus (RAD001)

DRUG

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

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RECRUITINGPHASE1

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease