RAD001 in Advanced Sarcoma
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ClinicalTrials.gov Identifier: NCT01830153 |
Recruitment Status
:
Completed
First Posted
: April 12, 2013
Last Update Posted
: April 12, 2013
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Condition or disease | Intervention/treatment | Phase |
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Soft Tissue Sarcomas Bone Sarcomas | Drug: RAD001 | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: RAD001
RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.
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Drug: RAD001
Other Name: Everolimus
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- 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
- 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.
- Overall survival [ Time Frame: Up to 24 months ]Defined from the initiation of everolimus to death of any cause.
- Response rate [ Time Frame: Up to 24 months ]Defined as the proportion of complete response and partial response per RECIST criteria.
- Toxicity [ Time Frame: Up to 24 months ]Any adverse events occurred during the treatment with study drug.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830153
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 |
Principal Investigator: | Jin-Hee Ahn, MD, PhD | Asan Medical Center |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |