RAD001 in Advanced Sarcoma

Soft Tissue Sarcomas Clinical Trial

Official title:

A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830153
• Other study ID #: CRAD001CKR13T
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2013
• Last updated: April 11, 2013
• Start date: April 2010

Study information

• Verified date: April 2013
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.

Description:

This multicenter, phase II trial evaluated the efficacy and safety of everolimus in patients with metastatic or recurrent bone and soft tissue sarcoma after failure of anthracycline and/or ifosfamide.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Sarcomas
• Osteosarcoma
• Sarcoma
• Soft Tissue Sarcomas

Intervention

Drug:
• RAD001

Locations

Country	Name	City	State
Korea, Republic of	Yeongnam University College of Medicine	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul	N/A = Not Applicable
Korea, Republic of	Korea University	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei Cancer Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Novartis

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

Clark MA, Fisher C, Judson I, Thomas JM. Soft-tissue sarcomas in adults. N Engl J Med. 2005 Aug 18;353(7):701-11. Review. — View Citation

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. — View Citation

Hartmann JT, Patel S. Recent developments in salvage chemotherapy for patients with metastatic soft tissue sarcoma. Drugs. 2005;65(2):167-78. Review. — View Citation

Le 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. — View Citation

Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grünwald 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. — View Citation

Santoro 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. — View Citation

van 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. — View Citation

Verweij 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. — View Citation

Wan X, Helman LJ. The biology behind mTOR inhibition in sarcoma. Oncologist. 2007 Aug;12(8):1007-18. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Progression-free survival	Defined as the time from the initiation of everolimus to disease progression or death, whichever occurred first.	Up to 24 months	No
Secondary	Overall survival	Defined from the initiation of everolimus to death of any cause.	Up to 24 months	No
Secondary	Response rate	Defined as the proportion of complete response and partial response per RECIST criteria.	Up to 24 months	No
Secondary	Toxicity	Any adverse events occurred during the treatment with study drug.	Up to 24 months	Yes