Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00419159
First received: January 4, 2007
Last updated: November 4, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: Everolimus (RAD001) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Imaging every 8 weeks ] [ Designated as safety issue: No ]
RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments.
Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response).
- The Number of Participants With Best Overall Response: Complete Response (CR, No Lesions), Partial Response (PR, 30% Decrease in Lesions), and Stable Disease (SD, None of the Above) According to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Imaging every 8 weeks ] [ Designated as safety issue: No ]RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments.
Secondary Outcome Measures:
- Progression-free Survival (PFS) [ Time Frame: Imaging every 8 weeks ] [ Designated as safety issue: No ]Duration in months from the date of first study treatment to the date of the first documented disease progression or death due to any cause.
- Overall Survival (OS) [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]Overall survival defined as the time from date of first study treatment to the date of death due to any cause.
- Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr). [ Time Frame: From the first day of treatment until 28 days after discontinuation of study treatment ] [ Designated as safety issue: Yes ]Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAEv3.0). On treatment death defined as deaths occurring no more than 28 days after the discontinuation of study treatment.
- Biomarkers Predictive of Clinical Benefit on Everolimus (RAD001) [ Time Frame: Screening and Day 1 of cycles 2, 3, 4 and end of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 199 |
| Study Start Date: | December 2006 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Everolimus (RAD001) 70 mg/week |
Drug: Everolimus (RAD001)
Everolimus was supplied in 5 mg tablets in blister packs.
Other Names:
|
| Experimental: Everolimus (RAD001) 10 mg/day |
Drug: Everolimus (RAD001)
Everolimus was supplied in 5 mg tablets in blister packs.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419159
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419159
Locations
| United States, Nevada | |
| Nevada Cancer Institute | |
| Las Vegas, Nevada, United States, 89135 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00419159 History of Changes |
| Other Study ID Numbers: | CRAD001C2241 |
| Study First Received: | January 4, 2007 |
| Results First Received: | December 17, 2010 |
| Last Updated: | November 4, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Italy: Ministry of Health Spain: Spanish Agency of Medicines |
Keywords provided by Novartis:
|
Colorectal cancer metastatic colorectal adenocarcinoma anti-EGFR antibody |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Everolimus |
Sirolimus Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents Antineoplastic Agents Immunologic Factors Immunosuppressive Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015