search
Back to results

RAD001 in Advanced Sarcoma

Primary Purpose

Soft Tissue Sarcomas, Bone Sarcomas

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RAD001
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcomas focused on measuring Soft tissue sarcomas, Bone sarcomas, RAD001, Refractory to conventional chemotherapy

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with histologically confirmed metastatic, unresectable bone or soft tissue sarcomas who had past treatment with anthracycline and/or ifosfamide to which the disease was primarily refractory or progressed after initial response.
  • Any of above drugs is allowed to be used as adjuvant treatment.
  • Unidimensionally measurable disease
  • 3 or less than prior chemotherapies
  • Age 17 years old or older
  • ECOG performance status 2 or less, Life expectancy 6 month or less
  • Adequate bone marrow, liver, kidney, and cardiac function
  • Written informed consent

Exclusion Criteria:

  • Pregnant or lactating patients
  • Patients with resectable metastasis
  • Patients with history of CNS metastasis
  • Gastrointestinal stromal tumors, chondrosarcoma, neuroblastoma
  • Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.
  • Any preexisting medical condition of sufficient severity to prevent full compliance with the study

Sites / Locations

  • Seoul National University Bundang Hospital
  • Asan Medical Center, University of Ulsan College of Medicine
  • Yeongnam University College of Medicine
  • Chungnam National University Hospital
  • Seoul National University Hospital
  • Yonsei Cancer Center
  • Korea University
  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RAD001

Arm Description

RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.

Outcomes

Primary Outcome Measures

Progression-free survival rate at 16 weeks
Determined as the proportion of progression-free (complete response, partial response and stable disease) at 16 weeks of treatment

Secondary Outcome Measures

Progression-free survival
Defined as the time from the initiation of everolimus to disease progression or death, whichever occurred first.
Overall survival
Defined from the initiation of everolimus to death of any cause.
Response rate
Defined as the proportion of complete response and partial response per RECIST criteria.
Toxicity
Any adverse events occurred during the treatment with study drug.

Full Information

First Posted
April 10, 2013
Last Updated
April 11, 2013
Sponsor
Asan Medical Center
Collaborators
Novartis
search

1. Study Identification

Unique Protocol Identification Number
NCT01830153
Brief Title
RAD001 in Advanced Sarcoma
Official Title
A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.
Detailed Description
This multicenter, phase II trial evaluated the efficacy and safety of everolimus in patients with metastatic or recurrent bone and soft tissue sarcoma after failure of anthracycline and/or ifosfamide.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcomas, Bone Sarcomas
Keywords
Soft tissue sarcomas, Bone sarcomas, RAD001, Refractory to conventional chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAD001
Arm Type
Experimental
Arm Description
RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.
Intervention Type
Drug
Intervention Name(s)
RAD001
Other Intervention Name(s)
Everolimus
Primary Outcome Measure Information:
Title
Progression-free survival rate at 16 weeks
Description
Determined as the proportion of progression-free (complete response, partial response and stable disease) at 16 weeks of treatment
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Defined as the time from the initiation of everolimus to disease progression or death, whichever occurred first.
Time Frame
Up to 24 months
Title
Overall survival
Description
Defined from the initiation of everolimus to death of any cause.
Time Frame
Up to 24 months
Title
Response rate
Description
Defined as the proportion of complete response and partial response per RECIST criteria.
Time Frame
Up to 24 months
Title
Toxicity
Description
Any adverse events occurred during the treatment with study drug.
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically confirmed metastatic, unresectable bone or soft tissue sarcomas who had past treatment with anthracycline and/or ifosfamide to which the disease was primarily refractory or progressed after initial response. Any of above drugs is allowed to be used as adjuvant treatment. Unidimensionally measurable disease 3 or less than prior chemotherapies Age 17 years old or older ECOG performance status 2 or less, Life expectancy 6 month or less Adequate bone marrow, liver, kidney, and cardiac function Written informed consent Exclusion Criteria: Pregnant or lactating patients Patients with resectable metastasis Patients with history of CNS metastasis Gastrointestinal stromal tumors, chondrosarcoma, neuroblastoma Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients. Any preexisting medical condition of sufficient severity to prevent full compliance with the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Hee Ahn, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
State/Province
N/A = Not Applicable
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Yeongnam University College of Medicine
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Yonsei Cancer Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Korea University
City
Seoul
ZIP/Postal Code
126-1
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
8315424
Citation
Edmonson JH, Ryan LM, Blum RH, Brooks JS, Shiraki M, Frytak S, Parkinson DR. Randomized comparison of doxorubicin alone versus ifosfamide plus doxorubicin or mitomycin, doxorubicin, and cisplatin against advanced soft tissue sarcomas. J Clin Oncol. 1993 Jul;11(7):1269-75. doi: 10.1200/JCO.1993.11.7.1269.
Results Reference
background
PubMed Identifier
10811673
Citation
Verweij J, Lee SM, Ruka W, Buesa J, Coleman R, van Hoessel R, Seynaeve C, di Paola ED, van Glabbeke M, Tonelli D, Judson IR. Randomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: a study of the european organization for research and treatment of cancer soft tissue and bone sarcoma group. J Clin Oncol. 2000 May;18(10):2081-6. doi: 10.1200/JCO.2000.18.10.2081.
Results Reference
background
PubMed Identifier
15631540
Citation
Hartmann JT, Patel S. Recent developments in salvage chemotherapy for patients with metastatic soft tissue sarcoma. Drugs. 2005;65(2):167-78. doi: 10.2165/00003495-200565020-00002.
Results Reference
background
PubMed Identifier
7602342
Citation
Santoro A, Tursz T, Mouridsen H, Verweij J, Steward W, Somers R, Buesa J, Casali P, Spooner D, Rankin E, et al. Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 1995 Jul;13(7):1537-45. doi: 10.1200/JCO.1995.13.7.1537.
Results Reference
background
PubMed Identifier
10894866
Citation
Le Cesne A, Judson I, Crowther D, Rodenhuis S, Keizer HJ, Van Hoesel Q, Blay JY, Frisch J, Van Glabbeke M, Hermans C, Van Oosterom A, Tursz T, Verweij J. Randomized phase III study comparing conventional-dose doxorubicin plus ifosfamide versus high-dose doxorubicin plus ifosfamide plus recombinant human granulocyte-macrophage colony-stimulating factor in advanced soft tissue sarcomas: A trial of the European Organization for Research and Treatment of Cancer/Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 2000 Jul;18(14):2676-84. doi: 10.1200/JCO.2000.18.14.2676.
Results Reference
background
PubMed Identifier
12460784
Citation
van Oosterom AT, Mouridsen HT, Nielsen OS, Dombernowsky P, Krzemieniecki K, Judson I, Svancarova L, Spooner D, Hermans C, Van Glabbeke M, Verweij J; EORTC Soft Tissue and Bone Sarcoma Group. Results of randomised studies of the EORTC Soft Tissue and Bone Sarcoma Group (STBSG) with two different ifosfamide regimens in first- and second-line chemotherapy in advanced soft tissue sarcoma patients. Eur J Cancer. 2002 Dec;38(18):2397-406. doi: 10.1016/s0959-8049(02)00491-4.
Results Reference
background
PubMed Identifier
16107623
Citation
Clark MA, Fisher C, Judson I, Thomas JM. Soft-tissue sarcomas in adults. N Engl J Med. 2005 Aug 18;353(7):701-11. doi: 10.1056/NEJMra041866. No abstract available.
Results Reference
background
PubMed Identifier
17766661
Citation
Wan X, Helman LJ. The biology behind mTOR inhibition in sarcoma. Oncologist. 2007 Aug;12(8):1007-18. doi: 10.1634/theoncologist.12-8-1007.
Results Reference
background
PubMed Identifier
18653228
Citation
Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grunwald V, Thompson JA, Figlin RA, Hollaender N, Urbanowitz G, Berg WJ, Kay A, Lebwohl D, Ravaud A; RECORD-1 Study Group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008 Aug 9;372(9637):449-56. doi: 10.1016/S0140-6736(08)61039-9. Epub 2008 Jul 22.
Results Reference
background
PubMed Identifier
24037083
Citation
Yoo C, Lee J, Rha SY, Park KH, Kim TM, Kim YJ, Lee HJ, Lee KH, Ahn JH. Multicenter phase II study of everolimus in patients with metastatic or recurrent bone and soft-tissue sarcomas after failure of anthracycline and ifosfamide. Invest New Drugs. 2013 Dec;31(6):1602-8. doi: 10.1007/s10637-013-0028-7. Epub 2013 Sep 14.
Results Reference
derived

Learn more about this trial

RAD001 in Advanced Sarcoma

We'll reach out to this number within 24 hrs