Clinical trial · Interventional
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
NCT00419159CI-TRIAL-00038291completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus (RAD001) | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Everolimus (RAD001) 70 mg/week
- interventionNames
- Drug: Everolimus (RAD001)
- type
- EXPERIMENTAL
- label
- Everolimus (RAD001) 10 mg/day
- interventionNames
- Drug: Everolimus (RAD001)
Primary outcomes (2)
- measure
- Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)
- timeFrame
- Imaging every 8 weeks
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.