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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: November 4, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Progressive Sarcoma
Drug: Everolimus/RAD001
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 71
Study Start Date: March 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 = GIST Drug: Everolimus/RAD001
10 mg orally
Other Name: Afinitor
Experimental: 2 = Sarkoma Drug: Everolimus/RAD001
10 mg orally
Other Name: Afinitor
Experimental: 3 = ASPS Drug: Everolimus/RAD001
10 mg orally
Other Name: Afinitor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767819

Locations
Germany
Novartis Investigative Site
Bad Saarow, Germany, 155226
Novartis Investigative Site
Duesseldorf, Germany, 40479
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Mannheim, Germany, 68167
Novartis Investigative Site
Muenchen, Germany, 81377
Italy
Novartis Investigative Site
Milano, MI, Italy, 20133
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00767819     History of Changes
Other Study ID Numbers: CRAD001C24114, 2007-005294-60, EUDRACT- Nr. 2007-005294-60
Study First Received: October 6, 2008
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Italy: AIFA- Ufficio sperimentazioni cliniche

Keywords provided by Novartis:
progressive GIST
progressive sarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014