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Progressive SarcomaPhase 2NCT00767819

Treatment of Patients With RAD001 With Progressive Sarcoma

A Phase 2 study testing Everolimus in people with Progressive Sarcoma, run by Novartis Pharmaceuticals at 6 sites in 2 countries.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Progressive Sarcoma
What is being tested?
Everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
6 sitesin 2 countries
Study dates
31 Mar 2008to 17 May 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Germany5 sites

  • Novartis Investigative Site

    Bad Saarow, 15526

  • Novartis Investigative Site

    Düsseldorf, 40479

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Mannheim, 68167

  • Novartis Investigative Site

    München, 81377

Other trials in Germany

Italy1 site

  • Novartis Investigative Site

    Milan, MI, 20133

Other trials in Italy

About this study

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

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.

Being tested
Everolimus
Keywords
progressive GIST, progressive sarcoma

What participants receive

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

  • EverolimusDrug

    Also called RAD001

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

Study groups in NCT00767819
Study groupRoleWhat they receive
Arm 1ExperimentalProgressive or metastatic bone or soft tissue sarcomas
Receives: Drug: Everolimus
Arm 2ExperimentalProgressive gastrointestinal stromal tumors (GIST) after failure of prior imatinib and sunitinib 1st and 2nd line
Receives: Drug: Everolimus
Arm 3ExperimentalProgressive or metastatic alveolar soft part sarcoma (ASPS)
Receives: Drug: Everolimus

What is being measured

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

  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.

    Measured: Baseline up to 16 weeks

Secondary outcomes (5)

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

    The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Best lesion response was defined by (Resist Criteria V1 for target and non-target lesions).

    Measured: Baseline up to approximately 16 weeks

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

    Duration of response (CR, PR or SD) applied only to those patients whose best overall response was CR, PR or SD based on local radiologic assessments and was defined as the time from start of treatment to progression or death from underlying disease. Patients not experiencing progression or death at 16 weeks were censored with the date of their last tumor assessment. Duration of response was explored using the Kaplan-Meier method.

    Measured: Baseline up to 16 weeks

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

    Progression-free Survival (PFS) was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death from any cause. If a patient had not had an event, PFS was censored at the date of the last adequate tumor assessment at week 16

    Measured: 16 weeks

  4. Time to Progression (TTP) (ITT)

    Time to progression (TTP) was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death from underlying disease. If a patient had not had an event, TTP was censored at the date of the last adequate tumor assessment, which was the date of Visit 6 (Week 16) for the core phase and the last available tumor assessment for the follow-up phase. TTP was explored by using the Kaplan-Meier method.

    Measured: Baseline up to 16 weeks

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

    Overall survival (OS) was defined as the time from the date of start of treatment to death from any cause. If a patient was not known to have died (was alive), OS was censored at the date of the last contact, which was the date of Visit 6 (Week 16) for the core phase and the last available visit for the follow-up phase. OS was explored by using the Kaplan-Meier method. One death occurred in Arm 3 after Week 16.

    Measured: Baseline up to 16 weeks

Timeline

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

  1. First posted7 Oct 2008 (estimated)
  2. Study start31 Mar 2008
  3. Primary completion17 May 2017
  4. Study completion17 May 2017

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
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00767819
Sponsor's protocol ID
CRAD001C24114
Other IDs
2007-005294-60
Status last verified
Dec 2018
First submitted
6 Oct 2008
Last updated
1 Apr 2019
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus in people with Progressive Sarcoma, run by Novartis Pharmaceuticals at 6 sites in 2 countries.

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 23 inclusion and 10 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, Italy. 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?

Yes. Results are posted in the registry (first posted 1 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Best Overall Response Rates by Week 16 (ITT) (time frame: Baseline up to 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 NCT00767819.

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 1 Apr 2019.

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