Clinical trial · Interventional
Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors.
A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and RAD001 (XELOX-A-Ev) for Subjects With Advanced Solid Tumors
NCT00849550CI-TRIAL-00008736COBRAcompletedPhase 1ClinicalTrials.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)
The purpose of this study is to determine if RAD001 (everolimus) helps improve the standard treatment of XELOX-A (bevacizumab, oxaliplatin, capecitabine) in advanced solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- XELOX-A-Ev
- interventionNames
- Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)
Primary outcomes (1)
- measure
- To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors.
- timeFrame
- End of treatment phase
Secondary outcomes (2)
- measure
- Describe dose-limiting and non-dose-limiting toxicities
- timeFrame
- End of treatment phase
- measure
- preliminarily investigate the response rate and PFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must be 18 years or older * Must have a performance status of at least 70% (able to carry on most normal activities) * Must have life expectancy of at least 3 months * Must have adequate organ and marrow function as determined by lab tests * Women of child-bearing potential and men must agree to use two forms of contraception * Ability and willingness to sign a written informed consent document * Histologically confirmed solid tumor malignancy that is metastatic or unresectable Exclusion Criteria: * Pregnant or breastfeeding and/or lactating women * Patients who have received any other investigational agents within 28 days of the first day of study drug * Patients with known CNS metastases * History of other carcinomas within last 5 years (except non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer) * Inadequately controlled hypertension * Significant vascular disease * Invasion or encasement of a major artery * Evidence of bleeding diathesis or coagulopathy * Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 of study drug * Serious illness or medical condition * History of myocardial infarction, unstable angina, cardiac or other vascular stenting * History of stroke * HIV, Hepatitis C, Hepatitis B or other serious chronic infection * Impairment of Gastrointestinal function or disease * History of interstitial lung disease * Patients who have had radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within 28 days of receiving study drug.
References
Publications (0)
Data not yet available
No reference posted for this study.