Clinical trial · Interventional
Everolimus and Capecitabine in Patients With Advanced Malignancy
A Phase I/II, Non-randomized, Multi-center, Dose-escalating, Two-stage Efficacy and Feasibility Study of the Combination of Everolimus and Capecitabine in Patients With Advanced Malignancies
NCT01079702CI-TRIAL-00003231m-TORunknownPhase 1 / Phase 2ClinicalTrials.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)
In the investigators study the investigators combine everolimus, administrated twice daily at a fixed total dose of 10 mg continuously with capecitabine administered bid for 14 days followed by 7 days rest. In this study, capecitabine will be dose escalated.
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 |
|---|---|---|---|
| Advanced Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Phase I part: Assessment of dose limiting toxicity and maximum tolerated dose. II part: efficacy and feasibility. Primary endpoint of the study will be response rate.
- timeFrame
- During treatment: assessments on day 1 every cycle (3 weeks). After treatment: every 3 months during the first 2 years, and every 6 months thereafter
- description
- Three patients will be enrolled per dose level, starting at dose level 1. If one of the 3 patients develops dose-limiting toxicity at any dose level, 3 other patients will start at the same dose level. If 2 or more out of these 6 patients develop DLT, no further dose escalations will be performed. The MTD will be considered to be the dose given at the previous lower level. No intrapatient dose escalation will be applied.
Secondary outcomes (2)
- measure
- Time to treatment failure
- timeFrame
- Every 3 months during the first 2 years, and every 6 months thereafter.
- measure
- Toxicity profile.
- timeFrame
- During treatment: assessments on day 1 every cycle (3 weeks). After treatment: every 3 months during the first 2 years, and every 6 months thereafter.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histological or cytological confirmed malignancies * Measurable lesion according to RECIST criteria (only for the phase II part of the study) * ECOG / WHO performance status of 0-2 * Age ≥ 18 years * Life expectancy of at least 3 months * Minimal acceptable safety laboratory values defined as: * WBC ≥ 3.0 x 109 /L * Platelet count ≥ 100 x 109 /L * Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALT or AST ≤ 2.5 x ULN, in case of liver metastases ≤ 5 x ULN * Renal function as defined by creatinine \< 150μmol/L * Able and willing to give written informed consent * Able to swallow and retain oral medication * Able and willing to undergo blood sampling for pharmacokinetic and pharmacogenetic analysis * Mentally, physically and geographically able to undergo treatment and follow up. Exclusion Criteria: * Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up * Women who are pregnant or breast feeding * Women of childbearing potential who refuse to use a reliable contraceptive method throughout the study * Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator * Any other medical condition that would interfere with study procedures and/or decrease safety of the protocol treatment
References
Publications (0)
Data not yet available
No reference posted for this study.