Treatment of Patients With RAD001 Who Have Progressive Sarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00767819
First received: October 6, 2008
Last updated: June 5, 2014
Last verified: June 2014

October 6, 2008
June 5, 2014
March 2008
December 2014   (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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate duration of response [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • To evaluate progression-free survival (PFS) at 16 weeks. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • To evaluate overall survival (OS). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • To evaluate PFS at month 12 for patients with data available from follow-up observation (optional). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To evaluate OS at 12 months for patients with data available from follow-up observation (optional). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety and tolerability of RAD001 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • OR after 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • PFS after 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
71
December 2014
December 2014   (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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy
 
NCT00767819
CRAD001C24114, 2007-005294-60, EUDRACT- Nr. 2007-005294-60
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2014

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