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Completed

NCT Number: NCT01830153

RAD001 in Advanced Sarcoma

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

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Key information

Conditions

Soft Tissue Sarcomas Bone Diseases Bone Neoplasms Bone Sarcomas Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Sarcoma

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RAD001

Drug

Other names: Everolimus

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
First posted
Apr 12, 2013
Registry last updated
Apr 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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