Treatment of Patients With RAD001 Who Have Progressive Sarcoma
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00767819
First received: October 6, 2008
Last updated: January 29, 2013
Last verified: January 2013
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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: | 72 |
| 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
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: | January 29, 2013 |
| 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, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Everolimus Sirolimus Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013