RAD001 in Advanced Sarcoma

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Soft Tissue Sarcomas; Bone Sarcomas	Drug: RAD001	Phase 2

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	41 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas
Study Start Date :	April 2010
Actual Primary Completion Date :	January 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: RAD001; RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.	Drug: RAD001; Other Name: Everolimus

Outcome Measures

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Primary Outcome Measures :

1. Progression-free survival rate at 16 weeks [ Time Frame: 16 weeks ]
   Determined as the proportion of progression-free (complete response, partial response and stable disease) at 16 weeks of treatment

Secondary Outcome Measures :

1. Progression-free survival [ Time Frame: Up to 24 months ]
   Defined as the time from the initiation of everolimus to disease progression or death, whichever occurred first.
2. Overall survival [ Time Frame: Up to 24 months ]
   Defined from the initiation of everolimus to death of any cause.
3. Response rate [ Time Frame: Up to 24 months ]
   Defined as the proportion of complete response and partial response per RECIST criteria.
4. Toxicity [ Time Frame: Up to 24 months ]
   Any adverse events occurred during the treatment with study drug.

Eligibility Criteria

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Ages Eligible for Study:	17 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Asan Medical Center, University of Ulsan College of Medicine
Seoul, N/A = Not Applicable, Korea, Republic of, 138-736
Yeongnam University College of Medicine
Daegu, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of, 301-721
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Yonsei Cancer Center
Seoul, Korea, Republic of, 120-752
Korea University
Seoul, Korea, Republic of, 126-1
Samsung Medical Center
Seoul, Korea, Republic of, 135-710

Sponsors and Collaborators

Asan Medical Center

Novartis

Investigators

Principal Investigator:	Jin-Hee Ahn, MD, PhD	Asan Medical Center

More Information

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Publications:

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.

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.

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

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.

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.

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.

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.

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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yoo 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.

Responsible Party:	Jin-Hee Ahn, Professor, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT01830153 History of Changes
Other Study ID Numbers:	CRAD001CKR13T
First Posted:	April 12, 2013
Last Update Posted:	April 12, 2013
Last Verified:	April 2013

Keywords provided by Jin-Hee Ahn, Asan Medical Center:

Soft tissue sarcomas; Bone sarcomas; RAD001; Refractory to conventional chemotherapy

Additional relevant MeSH terms:

Sarcoma; Osteosarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Everolimus; Sirolimus	Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antifungal Agents