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Soft Tissue SarcomaPhase 2ARSARC-PI-0010NCT01259375

Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma

A Phase 2 study testing Amrubicin in people with Soft Tissue Sarcoma, run by University of Utah at 2 sites in United States.

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

Primary Objectives 1. To evaluate the Response Rate (RR) for amrubicin in patients with metastatic or advanced sarcoma as first line therapy. 2. To evaluate Progression Free Survival (PFS). Secondary Objectives 1. To assess the safety and tolerability of amrubicin in this patient population. 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Amrubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
Sep 2011to Feb 2016
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

  • Adult patients (age 18 years or older)
  • Pathological diagnosis of soft tissue sarcoma. Pathology materials must be submitted and reviewed.
  • Patients must have unresectable locally advanced or metastatic progressive disease prior to enrollment. Disease extent must be determined by scans (CT or PET CT) within 6 weeks of enrollment.
  • No prior chemotherapy for soft tissue sarcoma.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function including the following:
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  • Adequate bone marrow reserve: absolute neutrophil count (segmented and bands) (ANC) 1.5 x 109/L, platelet count 100 x 109/L, and hemoglobin 90 g/L,
  • Hepatic: bilirubin 1.5 x the upper limit of normal (ULN), ALT and AST 3.0 x ULN,
  • Renal: serum creatinine 1.5 x ULN or calculated creatinine clearance greater than 60 mL/min,
  • Cardiac: Left ventricular ejection fraction (LVEF) 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA);
  • All labs must be done within 2 weeks prior to enrollment.
  • Negative serum pregnancy test at the time of enrollment for females of childbearing potential;
  • For males and females of child-producing potential, use of effective contraceptive methods during the study;
  • Ability to understand the requirements of the study and provide written informed consent.

Who cannot join

  • Pregnant or nursing females
  • Chest radiotherapy with curative intent to the primary disease complex less than or equal to 28 days prior to first dose; cranial radiotherapy less than or equal to 21 days prior to first dose; radiotherapy to all other areas less than or equal to 7 days prior to first dose
  • Concurrent severe or uncontrolled medical disease (eg, active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure, active viral hepatitis or chronic liver disease) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study
  • Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable for 2 weeks after radiotherapy; if the patient is on corticosteroids, the dose of corticosteroids must have been stable for 2 weeks prior to first dose of study treatment, or be in the process of being tapered
  • Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.
  • Patients with known history of seropositive human immunodeficiency virus (HIV) or patients who are receiving immunosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications. HIV testing is not required for inclusion in the trial.
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  • Known hypersensitivity to any of the components of the i.v. formulation of amrubicin.
  • Psychiatric disorder or any other personal circumstances that prevent compliance with the study protocol.
  • Inability or unwillingness to comply with the study protocol.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Santa Monica

    Santa Monica, California, 90403

Other trials in United States

About this study

Official title: A Phase II Study of Amrubicin Chemotherapy as First Line Treatment in Patients With Metastatic or Unresectable Soft Tissue Sarcoma

Primary Objectives

  1. To evaluate the Response Rate (RR) for amrubicin in patients with metastatic or advanced sarcoma as first line therapy.
  2. To evaluate Progression Free Survival (PFS).

Secondary Objectives

  1. To assess the safety and tolerability of amrubicin in this patient population.
  2. To evaluate whether certain histologic subtypes of sarcoma demonstrate a differential response to amrubicin.
  3. To investigate quality of response with radiographic evaluation using both Response Evaluation Criteria In Solid Tumors (RECIST) and Choi criteria.
  4. To evaluate overall survival (OS).
Being tested
Amrubicin
Medical subject headings
Sarcoma

What participants receive

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

  • AmrubicinDrug

    Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously

Study groups in NCT01259375
Study groupRoleWhat they receive
All patientsExperimentalAll participants who received Amrubicin.
Receives: Drug: Amrubicin

What is being measured

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

  1. Response Rate for Amrubicin in Patients With Metastatic or Advanced Sarcoma as First Line Therapy.

    Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: 48 months

  2. Progression Free Survival

    Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.1) for target lesions and assessed by CT; time elapsed between treatment initiation and tumor progression or death. In target lesions, progression is defined per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In non-target lesions, progression is defined via RECIST v 1.1 as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: six months

Secondary outcomes (4)

  1. Number of Participants With Serious Adverse Events

    Measured: 4 months

  2. Overall Survival

    This variable reviews the percentage of Overall Survival at 24 months and presents the percentage of participants who survived at 2 years.

    Measured: two years

  3. Quality of Response With Radiographic Evaluation Using Both Response Evaluation Criteria In Solid Tumors (RECIST) and Choi Criteria.

    Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Exploratory CT evaluations according to Choi response criteria will be also performed and correlated with RECIST response.

    Measured: 48 months

  4. Differential Response to Amurbicin Among Certain Histologic Subtypes of Sarcoma.

    Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 48 months

Timeline

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

  1. First posted14 Dec 2010 (estimated)
  2. Study startSep 2011
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01259375
Sponsor's protocol ID
HCI45197
Acronym
ARSARC-PI-0010
Status last verified
Mar 2017
First submitted
10 Dec 2010
Last updated
17 Apr 2017
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amrubicin in people with Soft Tissue Sarcoma, run by University of Utah at 2 sites in United States.

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 14 inclusion and 9 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 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 17 Apr 2017). 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?

Response Rate for Amrubicin in Patients With Metastatic or Advanced Sarcoma as First Line Therapy. (time frame: 48 months). The study lists 2 primary outcomes in all. 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 NCT01259375.

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 17 Apr 2017.

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