NCT02066675

Brief Summary

Phase II, non-randomized, two-stage study according to Bryant \& Day The study enroll patients with Metastatic and locally advanced soft tissue sarcoma unfit to receive standard chemotherapy (doxorubicin/epirubicin and/or ifosfamide)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2014

Typical duration for phase_2

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

2.9 years

First QC Date

February 13, 2014

Last Update Submit

April 9, 2018

Conditions

Metastatic and Locally Advanced Soft Tissue Tumor Patients Unfit to ReceiveStandard Chemotherapy

Keywords

MetastaticLocally advancedSoft tissue tumors

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival Rate

    The primary end point of this trial is the Progression Free Survival Rate at 3 months Non progression, is defined as Complete Response, Partial Response or Stable Disease according to Response Evaluation Criteria In Solid Tumours v.1.1 criteria.

    3 Months

Secondary Outcomes (4)

  • Tolerability and intolerable adverse reaction rate.

    Day21

  • Objective response rate

    5 years

  • Progression free survival

    Average of 5 Months

  • Overall survival

    18 Months (average)

Study Arms (1)

Trabectedin

EXPERIMENTAL

Trabectedin administered at the dose of 1.5 mg/mq-1.3 mg/mq a 24-hour continuous infusion via a central venous access, every 3 weeks

Drug: Trabectedin

Interventions

TrabectedinDRUG

Each patients will receive intravenous trabectedin (1.5 mg/mq-1.3 mg/mq) over 24 hours every 3 weeks

Also known as: Yondelis
Trabectedin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≥18 years), who, in the judgment of the clinician, is deemed not suitable to receive an anthracycline and/or ifosfamide based chemotherapy;
  • Pathological diagnosis of soft tissue sarcoma
  • Inoperable, locally advanced or metastatic tumor;
  • Unsuited to receive doxorubicine and ifosfamide: ie stable arrhythmia, previous myocardial infarction; age≥80 years
  • Eastern Cooperative Oncology Group Performance Status 0-2
  • Glomerular filtration rate ≥30 mL per min
  • Adequate hematologic function: Hemoglobin ≥9 g/dL; Absolute neutrophil count ≥1,500/μL, and Platelet count ≥100,000/microliter
  • Creatinine phosphokinase \< 2.5 Upper Normal Limit
  • Adequate hepatic function: total bilirubin \< Upper Normal Limit, total alkaline phosphatase \< 2.5 Upper Normal Limit, or if \> 2.5 Upper Normal Limit consider alkaline phosphatase liver fraction or gamma-glutamyltransferase or 5' nucleotidase must be \< Transminase \<2.5 x Upper Normal Limit, Albumin \> 20 g/L.
  • Patient´s written informed consent

You may not qualify if:

  • Prior exposure to Trabectedin
  • Performance status ≥2.
  • Prior treatment with anthracyclines and or ifosfamide.
  • History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 or more years and judged of negligible potential of relapse.
  • Active viral hepatitis or chronic liver diseases, which in the judgement of the primary investigator represents a clinical contraindication to the therapy.
  • Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 6 months before enrolment, uncontrolled arterial hypertension or arrhythmias, left ventricular ejection fraction \<40%
  • Active major infection.
  • Other serious concomitant illnesses
  • Pregnant subjects or breast feeding, or planning to become pregnant within 6 months after the end of treatment All sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment and must agree to use highly effective contraception during treatment and for 6 months after the end of treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Ospedali Riuniti di Bergamo

Bergamo, BG, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST

Meldola, FC, Italy

Location

Ospedale Galliera

Genova, Genovs, Italy

Location

IRCCS Azienda Ospedaliera Universitaria San Martino IST

Genova, GE, Italy

Location

Ospedale Villa Scassi

Genova, GE, Italy

Location

Ospedale Misericordia e Dolce" Istituto Toscano Tumori, Azienda USL4

Prato, PO, Italy

Location

I.R.C.C. - Unit of Medical Oncology

Candiolo, Torino, 10060, Italy

Location

Presidio Sanitario Gradenigo

Torino, TO, 10153, Italy

Location

A.S.O. "SS Antonio e Biagio e Cesare Arrigo"

Alessandria, Italy

Location

Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

Bologna, 40136, Italy

Location

Ospedale SS. Trinità di Sora

Frosinone, Italy

Location

IST

Genova, Italy

Location

Policlinico Federico II Napoli

Napoli, Italy

Location

Istituto Oncologico Veneto

Padua, Italy

Location

Ospedale Giaccone

Palermo, Italy

Location

Campus Biomedico

Roma, Italy

Location

Related Publications (1)

  • Fayette J, Coquard IR, Alberti L, Boyle H, Meeus P, Decouvelaere AV, Thiesse P, Sunyach MP, Ranchere D, Blay JY. ET-743: a novel agent with activity in soft-tissue sarcomas. Curr Opin Oncol. 2006 Jul;18(4):347-53. doi: 10.1097/01.cco.0000228740.70379.3f.

    PMID: 16721129BACKGROUND

MeSH Terms

Conditions

Neoplasm MetastasisSoft Tissue Neoplasms

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by Site

Intervention Hierarchy (Ancestors)

DioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Federica Grosso, MD

    ASO SS Antonio e Biagio e C Arrigo Alessandria, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 19, 2014

Study Start

February 1, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

IT(16)