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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
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Jin-Hee Ahn, Asan Medical Center

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 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.
Drug: RAD001
Other Name: Everolimus



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.



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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

Information from the National Library of Medicine

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


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

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