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Soft Tissue SarcomasPhase 2NCT01830153

RAD001 in Advanced Sarcoma

A Phase 2 study testing RAD001 in people with Soft Tissue Sarcomas and Bone Sarcomas, run by Asan Medical Center at 8 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy. Read more about this study

Who is it for?
Ages 17 years and older
Conditions the study is for
Soft Tissue Sarcomas, Bone Sarcomas
What is being tested?
RAD001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
8 sitesSouth Korea
Study dates
Apr 2010to Jan 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

South Korea8 sites

  • Yeongnam University College of Medicine

    Daegu

  • Chungnam National University Hospital

    Daejeon, 301-721

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Asan Medical Center, University of Ulsan College of Medicine

    Seoul, N/A = Not Applicable, 138-736

  • Seoul National University Hospital

    Seoul, 110-744

  • Yonsei Cancer Center

    Seoul, 120-752

  • Korea University

    Seoul, 126-1

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

Official title: A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas

This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.

Read the 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.

Being tested
RAD001
Keywords
Soft tissue sarcomas, Bone sarcomas, RAD001, Refractory to conventional chemotherapy
Medical subject headings
Sarcoma, Bone Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RAD001Drug

    Also called Everolimus

Study groups in NCT01830153
Study groupRoleWhat they receive
RAD001ExperimentalRAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.
Receives: Drug: RAD001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 16 weeks

Secondary outcomes (4)

  1. Progression-free survival

    Defined as the time from the initiation of everolimus to disease progression or death, whichever occurred first.

    Measured: Up to 24 months

  2. Overall survival

    Defined from the initiation of everolimus to death of any cause.

    Measured: Up to 24 months

  3. Response rate

    Defined as the proportion of complete response and partial response per RECIST criteria.

    Measured: Up to 24 months

  4. Toxicity

    Any adverse events occurred during the treatment with study drug.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2013 (estimated)
  2. Study startApr 2010
  3. Primary completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01830153
Sponsor's protocol ID
CRAD001CKR13T
Status last verified
Apr 2013
First submitted
10 Apr 2013
Last updated
12 Apr 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 8315424

  • 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.

    PubMed 10811673

  • 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.

    PubMed 15631540

  • 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.

    PubMed 7602342

  • 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.

    PubMed 10894866

  • 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.

    PubMed 12460784

  • 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.

    PubMed 16107623

  • 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.

    PubMed 17766661

  • 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.

    PubMed 18653228

  • 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.

    PubMed 24037083

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RAD001 in people with Soft Tissue Sarcomas and Bone Sarcomas, run by Asan Medical Center at 8 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival rate at 16 weeks (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01830153, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2013.

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