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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Progressive Sarcoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

16 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C24114

NCT ID:

NCT00767819

Start Date:

March 2008

Completion Date:

December 2014

Related Keywords:

  • Progressive Sarcoma
  • progressive GIST
  • progressive sarcoma
  • Sarcoma

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