Treatment of Patients With RAD001 With Progressive Sarcoma

NCT00767819 | Completed Phase 2 Results

• 2 other identifiers: CRAD001C241142007-005294-60
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 6

Brief Summary

The purpose of this multicenter, three-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.

Conditions

Progressive Sarcoma

Keywords

progressive GIST; progressive sarcoma

Outcome Measures

Primary Outcomes (1)

• Best Overall Response Rates by Week 16 (ITT)

  The best overall response is the best response recorded from treatment start until disease progression/recurrence (both measurement and confirmation criteria). Best lesion response was defined by (Resist Criteria V1 for target and non-target lesions): Complete Response (CR)=at least two determinations of CR 4 weeks apart before progression, Partial Response (PR)=at least two determinations of CR 4 weeks apart before progression (and not qualifying for a CR), Stable Disease (SD)=at least one SD assessment \>6 weeks after start of treatment and Progressive Disease (PD)=Progression or death due to underlying cancer ≤16 weeks after start of treatment. PD without radiologic evidence were classified as progression only, when clear evidence of clinical deterioration was available and patient discontinued due to "disease progression". Unknown (UNK) = all other cases.

  Baseline up to 16 weeks

Secondary Outcomes (5)

• Objective Tumor Response Rates (Complete Response and Partial Response) at Week 16 (ITT)

  Baseline up to approximately 16 weeks

• Percentage of Participants With Duration of Response (CR, PR, SD) at 16 Weeks.

  Baseline up to 16 weeks

• Percentage of Participants With Progression-free Survival (PFS) at 16 Weeks

  16 weeks

• Time to Progression (TTP) (ITT)

  Baseline up to 16 weeks

• Percentage of Participants With Overall Survival (OS) at Week 16 (ITT)

  Baseline up to 16 weeks

Study Arms (3)

Arm 1

EXPERIMENTAL

Progressive or metastatic bone or soft tissue sarcomas

Drug: Everolimus

Arm 2

EXPERIMENTAL

Progressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line

Drug: Everolimus

Arm 3

EXPERIMENTAL

Progressive or metastatic alveolar soft part sarcoma (ASPS)

Drug: Everolimus

Interventions

Everolimus DRUG

2.5 and 5 mg tablets taken orally and starting dose was 10 mg daily for all patients

Also known as: RAD001

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Bad Saarow, 15526, Germany

Location

Novartis Investigative Site

Düsseldorf, 40479, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Mannheim, 68167, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 7, 2008
• Study Start: March 31, 2008
• Primary Completion: May 17, 2017
• Study Completion: May 17, 2017
• Last Updated: April 1, 2019
• Results First Posted: April 1, 2019

Record last verified: 2018-12

Locations

DE (5); IT (1)