Clinical trial · Interventional
RAD001 in Advanced Sarcoma
A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas
NCT01830153CI-TRIAL-00010042completedPhase 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)
This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.
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 |
|---|---|---|---|
| Bone Sarcomas | Bone Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Soft Tissue Sarcomas | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAD001 | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RAD001
- description
- RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.
- interventionNames
- Drug: RAD001
Primary outcomes (1)
- measure
- Progression-free survival rate at 16 weeks
- timeFrame
- 16 weeks
- description
- Determined as the proportion of progression-free (complete response, partial response and stable disease) at 16 weeks of treatment
Secondary outcomes (4)
- measure
- Progression-free survival
- timeFrame
- Up to 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed metastatic, unresectable bone or soft tissue sarcomas who had past treatment with anthracycline and/or ifosfamide to which the disease was primarily refractory or progressed after initial response. * Any of above drugs is allowed to be used as adjuvant treatment. * Unidimensionally measurable disease * 3 or less than prior chemotherapies * Age 17 years old or older * ECOG performance status 2 or less, Life expectancy 6 month or less * Adequate bone marrow, liver, kidney, and cardiac function * Written informed consent Exclusion Criteria: * Pregnant or lactating patients * Patients with resectable metastasis * Patients with history of CNS metastasis * Gastrointestinal stromal tumors, chondrosarcoma, neuroblastoma * Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients. * Any preexisting medical condition of sufficient severity to prevent full compliance with the study
References
Publications (10)
- BACKGROUNDEdmonson JH, Ryan LM, Blum RH, Brooks JS, Shiraki M, Frytak S, Parkinson DR. Randomized comparison of doxorubicin alone versus ifosfamide plus doxorubicin or mitomycin, doxorubicin, and cisplatin against advanced soft tissue sarcomas. J Clin Oncol. 1993 Jul;11(7):1269-75. doi: 10.1200/JCO.1993.11.7.1269. PMID 8315424
- BACKGROUNDVerweij J, Lee SM, Ruka W, Buesa J, Coleman R, van Hoessel R, Seynaeve C, di Paola ED, van Glabbeke M, Tonelli D, Judson IR. Randomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: a study of the european organization for research and treatment of cancer soft tissue and bone sarcoma group. J Clin Oncol. 2000 May;18(10):2081-6. doi: 10.1200/JCO.2000.18.10.2081. PMID 10811673
- BACKGROUNDHartmann JT, Patel S. Recent developments in salvage chemotherapy for patients with metastatic soft tissue sarcoma. Drugs. 2005;65(2):167-78. doi: 10.2165/00003495-200565020-00002. PMID 15631540
- BACKGROUNDSantoro A, Tursz T, Mouridsen H, Verweij J, Steward W, Somers R, Buesa J, Casali P, Spooner D, Rankin E, et al. Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 1995 Jul;13(7):1537-45. doi: 10.1200/JCO.1995.13.7.1537. PMID 7602342
- BACKGROUNDLe Cesne A, Judson I, Crowther D, Rodenhuis S, Keizer HJ, Van Hoesel Q, Blay JY, Frisch J, Van Glabbeke M, Hermans C, Van Oosterom A, Tursz T, Verweij J. Randomized phase III study comparing conventional-dose doxorubicin plus ifosfamide versus high-dose doxorubicin plus ifosfamide plus recombinant human granulocyte-macrophage colony-stimulating factor in advanced soft tissue sarcomas: A trial of the European Organization for Research and Treatment of Cancer/Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 2000 Jul;18(14):2676-84. doi: 10.1200/JCO.2000.18.14.2676. PMID 10894866