RAD001 in Advanced Sarcoma
A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas
1 other identifier
interventional
41
1 country
8
Brief Summary
This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 10, 2013
CompletedFirst Posted
Study publicly available on registry
April 12, 2013
CompletedApril 12, 2013
April 1, 2013
2.8 years
April 10, 2013
April 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival rate at 16 weeks
Determined as the proportion of progression-free (complete response, partial response and stable disease) at 16 weeks of treatment
16 weeks
Secondary Outcomes (4)
Progression-free survival
Up to 24 months
Overall survival
Up to 24 months
Response rate
Up to 24 months
Toxicity
Up to 24 months
Study Arms (1)
RAD001
EXPERIMENTALRAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asan Medical Centerlead
- Novartiscollaborator
Study Sites (8)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Asan Medical Center, University of Ulsan College of Medicine
Seoul, N/A = Not Applicable, 138-736, South Korea
Yeongnam University College of Medicine
Daegu, South Korea
Chungnam National University Hospital
Daejeon, 301-721, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Yonsei Cancer Center
Seoul, 120-752, South Korea
Korea University
Seoul, 126-1, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (10)
Edmonson 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: 8315424BACKGROUNDVerweij 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: 10811673BACKGROUNDHartmann 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: 15631540BACKGROUNDSantoro 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: 7602342BACKGROUNDLe 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: 10894866BACKGROUNDvan Oosterom AT, Mouridsen HT, Nielsen OS, Dombernowsky P, Krzemieniecki K, Judson I, Svancarova L, Spooner D, Hermans C, Van Glabbeke M, Verweij J; EORTC Soft Tissue and Bone Sarcoma Group. Results of randomised studies of the EORTC Soft Tissue and Bone Sarcoma Group (STBSG) with two different ifosfamide regimens in first- and second-line chemotherapy in advanced soft tissue sarcoma patients. Eur J Cancer. 2002 Dec;38(18):2397-406. doi: 10.1016/s0959-8049(02)00491-4.
PMID: 12460784BACKGROUNDClark MA, Fisher C, Judson I, Thomas JM. Soft-tissue sarcomas in adults. N Engl J Med. 2005 Aug 18;353(7):701-11. doi: 10.1056/NEJMra041866. No abstract available.
PMID: 16107623BACKGROUNDWan X, Helman LJ. The biology behind mTOR inhibition in sarcoma. Oncologist. 2007 Aug;12(8):1007-18. doi: 10.1634/theoncologist.12-8-1007.
PMID: 17766661BACKGROUNDMotzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grunwald V, Thompson JA, Figlin RA, Hollaender N, Urbanowitz G, Berg WJ, Kay A, Lebwohl D, Ravaud A; RECORD-1 Study Group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008 Aug 9;372(9637):449-56. doi: 10.1016/S0140-6736(08)61039-9. Epub 2008 Jul 22.
PMID: 18653228BACKGROUNDYoo C, Lee J, Rha SY, Park KH, Kim TM, Kim YJ, Lee HJ, Lee KH, Ahn JH. Multicenter phase II study of everolimus in patients with metastatic or recurrent bone and soft-tissue sarcomas after failure of anthracycline and ifosfamide. Invest New Drugs. 2013 Dec;31(6):1602-8. doi: 10.1007/s10637-013-0028-7. Epub 2013 Sep 14.
PMID: 24037083DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Hee Ahn, MD, PhD
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 10, 2013
First Posted
April 12, 2013
Study Start
April 1, 2010
Primary Completion
January 1, 2013
Last Updated
April 12, 2013
Record last verified: 2013-04