Clinical trial · Interventional
Study of RAD001 + AMG479 for Patients With Advanced Solid Tumors
Phase I Study of mTOR Inhibitor RAD001 in Combination With IGF-1R Inhibitor AMG479 for Patients With Advanced Solid Tumors
NCT01122199CI-TRIAL-00027495completedPhase 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 test the safety of the combination of two drugs called RAD001 and AMG479. This study will see what effects (good and bad) RAD001 and AMG479 have on cancer. This study will also find the highest doses of RAD001 and AMG479 that can be given without causing severe side effects.
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 |
|---|---|---|---|
| Neoplasm Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAD001 + AMG479 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open Label
- description
- RAD001+ AMG479
- interventionNames
- Drug: RAD001 + AMG479
Primary outcomes (2)
- measure
- To determine the maximum tolerated (MTD) and recommended Phase II doses for AMG479 and RAD001 in patients with refractory solid tumors
- timeFrame
- 1 year
- measure
- To evaluate the grade and severity of adverse events as a measure of safety and toxicity
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- To determine preliminary antitumor efficacy of AMG479 and RAD001 in solid tumors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological proof of metastatic solid tumor refractory to standard therapies, or for which no standard therapies are available. * Patients in the expansion cohort must have a measurable site of disease according to RECIST (v 1.0) * Laboratory values must be obtained within protocol limits and obtained within 14 days prior to registration * Patients must have disease which is not amenable to potentially curative surgical resection of metastatic disease (curative metastasectomy). * Must be willing to provide metastatic tissue biopsy samples (may be paraffin embedded) at baseline * Must be willing to undergo a metastatic tissue biopsy after 2 cycles of therapy to perform pharmacodynamic research biomarkers testing. * Subjects must be willing and able to abstain from using strong or moderate CYP3A4 inhibitors or inducers during the study period. Exclusion Criteria: * No symptomatic brain metastasis * No prior treatment with an mTOR inhibitor or with an IGF-1R inhibitor * No known history of diabetes mellitus * No thrombosis or vascular ischemic events within the last twelve months * No chronic treatment with systemic steroids or another immunosuppressive agent * No active bleeding or a pathological condition that is associated with a high risk of bleeding * No known history of HIV seropositivity * No known history of Hepatitis B or Hepatitis C seropositivity * No known hypersensitivity to AMG 479, RAD001 (everolimus), other rapamycins (sirolimus, temsirolimus), or to its excipients * No planned immunization with attenuated live viruses during the study period
References
Publications (0)
Data not yet available
No reference posted for this study.