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Treatment of Patients With RAD001 Who Have Progressive Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00767819
First Posted: October 7, 2008
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
October 6, 2008
October 7, 2008
October 5, 2017
March 31, 2008
May 17, 2017   (Final data collection date for primary outcome measure)
  • Preliminary efficacy of RAD001 in progressive or metastatic bone and soft tissue sarcoma (except for GIST) defined as the proportion complete response, partial response or stable disease at 16 weeks. [ Time Frame: 16 weeks ]
  • Preliminary efficacy of RAD001 in patients with GIST after failure or intolerance of treatment with imatinib or sunitinib in 1st and 2nd line defined as the proportion of patients showing complete response, partial response or stable disease at 16 weeks. [ Time Frame: 16 weeks ]
  • To evaluate preliminary efficacy of RAD001 in progressive or metastatic alveolar soft part sarcoma (ASPS). Efficacy is defined as the proportion of patients showing complete response, partial response or stable disease at 16 weeks. [ Time Frame: 16 weeks ]
  • Preliminary efficacy of RAD001 in progressive or metastatic bone and soft tissue sarcoma (except for GIST) defined as the proportion complete response, partial response or stable disease at 16 weeks. [ Time Frame: 16 weeks ]
  • Preliminary efficacy of RAD001 in patients with GIST after failure or intolerance of treatment with imatinib or sunitinib in 1st and 2nd line defined as the proportion of patients showing complete response, partial response or stable disease at 16 weeks. [ Time Frame: 16 weeks ]
Complete list of historical versions of study NCT00767819 on ClinicalTrials.gov Archive Site
  • To evaluate the tolerability and safety profile of RAD001 in these patient populations. [ Time Frame: 16 weeks ]
  • To evaluate the objective tumor response rate based on RECIST-criteria (complete response [CR] and partial response [PR]) at 16 weeks. [ Time Frame: 16 weeks ]
  • To evaluate duration of response [ Time Frame: 16 weeks ]
  • To evaluate progression-free survival (PFS) at 16 weeks. [ Time Frame: 16 weeks ]
  • To evaluate overall survival (OS). [ Time Frame: 16 weeks ]
  • To evaluate PFS at month 12 for patients with data available from follow-up observation (optional). [ Time Frame: 12 months ]
  • To evaluate OS at 12 months for patients with data available from follow-up observation (optional). [ Time Frame: 12 months ]
  • Safety and tolerability of RAD001 [ Time Frame: 16 weeks ]
  • OR after 16 weeks [ Time Frame: 16 weeks ]
  • Duration of response [ Time Frame: 16 weeks ]
  • PFS after 16 weeks [ Time Frame: 16 weeks ]
Not Provided
Not Provided
 
Treatment of Patients With RAD001 Who Have Progressive Sarcoma
Multicenter, Triple-arm, Single-stage, Phase II Trial to Determine the Preliminary Efficacy and Safety of RAD001 in Patients With Histological Evidence of Progressive or Metastatic Bone or Soft Tissue Sarcomas
The purpose of this multicenter, two-arm, exact binomial single-stage, phase II trial is to determine the preliminary efficacy and safety of RAD001 in patients with histological evidence of progressive or metastatic bone or soft tissue sarcoma.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Progressive Sarcoma
Drug: Everolimus/RAD001
10 mg orally
Other Name: Afinitor
  • Experimental: 1 = GIST
    Intervention: Drug: Everolimus/RAD001
  • Experimental: 2 = Sarkoma
    Intervention: Drug: Everolimus/RAD001
  • Experimental: 3 = ASPS
    Intervention: Drug: Everolimus/RAD001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
May 17, 2017
May 17, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Histological evidence of progressive or metastatic bone or soft tissue sarcoma.

The following tumor types are included:

  • malignant fibrous histiocytoma
  • liposarcoma
  • synovial sarcoma
  • malignant paraganglioma
  • fibrosarcoma
  • leiomyosarcoma
  • angiosarcoma including haemangiopericytoma
  • malignant peripheral nerve sheath tumor
  • STS, not otherwise specified
  • miscellaneous sarcoma including mixed mesodermal tumors of the uterus
  • osteosarcoma
  • Ewing's sarcoma
  • rhabdomyosarcoma
  • gastrointestinal stromal tumor (only after failure or intolerance of imatinib or sunitinib in 1st and 2nd line)
  • alveolar soft part sarcoma (ASPS)

    • Objective progression of disease may be documented by RECIST criteria. Any of the following would be sufficient according to RECIST:
  • a 20% increase in the sum of unidimensionally measured target lesions
  • a new lesion
  • unequivocal increase in non-measurable disease.

    • Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent.
    • ECOG performance status 0 - 2.

Exclusion Criteria:

Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, or radiotherapy.

  • The following tumor types will not be included:

    • gastrointestinal stromal tumor (except for patients after treatment with imatinib or sunitinib in 1st and 2nd line)
    • chondrosarcoma
    • malignant mesothelioma
    • neuroblastoma.
  • Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
  • Neurotoxicity > grade 2 CTC.
  • Radiation of the lung.

Other protocol-defined inclusion/exclusion criteria may apply

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy
 
 
NCT00767819
CRAD001C24114
2007-005294-60 ( EudraCT Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP