NCT01995981

Brief Summary

This study is a phase IV post registration prospective observational feasibility study in patients with metastatic soft tissue sarcoma. Pazopanib is the registered treatment for patients with advanced soft tissue sarcoma after chemotherapy with doxorubicin or ifosfamide.

  • This study looks at the possibility of using 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography PET scans as an early biomarker of pazopanib treatment effect in patients.
  • It also studies pazopanib pharmacokinetics to see if there are differences between elderly and younger patients. The primary objectives are:
  • To evaluate whether early metabolic response is correlated to clinical benefit.
  • To evaluate the effect of age (≥ 70 years) on pazopanib pharmacokinetics. The secondary objectives are:
  • To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib therapy) is correlated with pazopanib exposure.
  • To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib therapy) is correlated with the histological subtypes.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
2 countries

2 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

First Submitted

Initial submission to the registry

November 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2017

Completed
Last Updated

December 19, 2017

Status Verified

June 1, 2015

Enrollment Period

3.9 years

First QC Date

November 21, 2013

Last Update Submit

December 18, 2017

Conditions

Sarcoma, Soft Tissue

Keywords

Sarcoma, Soft TissuePazopanibPositron-Emission TomographyPharmacokineticsBiomarker

Outcome Measures

Primary Outcomes (2)

  • FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) uptake

    baseline, 2 weeks and 8 weeks after start treatment

  • Pharmacokinetics (AUC)

    This measurement is performed at 2 weeks and 8 weeks after start treatment

    0, 1, 2, 3, 4, 6, 8, 10, 24 hours post-dose

Secondary Outcomes (1)

  • Adverse events (CTCAE v4.0)

    2 weeks and 8 weeks after start treatment

Study Arms (1)

Advanced soft tissue sarcoma patients

Advanced soft tissue sarcoma patients, who have an indication for pazopanib treatment.

Drug: Pazopanib

Interventions

PazopanibDRUG
Also known as: Votrient
Advanced soft tissue sarcoma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced soft tissue sarcoma who have an indication for pazopanib treatment.

You may qualify if:

  • Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
  • Age ≥ 18 years. Patients aged 66-69 are eligible for the imaging arm of the study, however they are excluded from the assessment of altered pharmacokinetic behavior in elderly.
  • Histological confirmed diagnosis of selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. The following subtypes are eligible:
  • Fibroblastic, so-called fibrohistiocytic, leiomyosarcoma, malignant glomus tumours, skeletal muscles, vascular, uncertain differentiation. The following subtypes are NOT eligible: Adipocytic sarcoma (all subtypes), all rhabdomyosarcoma that were not alveolar or pleomorphic, chondrosarcoma, osteosarcoma, Ewing tumours/primitive neuroectodermal tumor, GIST, dermatofibrosarcoma protuberance, inflammatory myofibroblastic sarcoma, malignant mesothelioma and mixed mesodermal tumours of the uterus.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Measurable disease criteria (RECIST 1.1).
  • No radio-, chemo- or tumor specific targeted therapy within the last 4 weeks prior to study entry.
  • Adequate organ system function as defined in the research protocol.
  • Minimal evaluable lesion of ≥ 15mm.

You may not qualify if:

  • Prior malignancy.
  • Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 6 months time interval.
  • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including.
  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including.
  • Corrected QT interval (QTc) \> 480msecs.
  • History of any one or more of the following cardiovascular conditions within the past 6 months:
  • Cardiac angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • Coronary artery bypass graft surgery
  • Symptomatic peripheral vascular disease
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
  • Poorly controlled hypertension
  • History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboud University Nijmegen Medical Centre

Nijmegen, 6525 GA, Netherlands

Location

Royal Marsden Hospital

London, United Kingdom

Location

Related Publications (1)

  • van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schoffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; PALETTE study group. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012 May 19;379(9829):1879-86. doi: 10.1016/S0140-6736(12)60651-5. Epub 2012 May 16.

    PMID: 22595799BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Sarcoma

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Winette van der Graaf, prof. PhD. MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Wim Oyen, prof. PhD. MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Nielka van Erp, PharmD. PhD.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 27, 2013

Study Start

December 1, 2013

Primary Completion

November 10, 2017

Study Completion

November 10, 2017

Last Updated

December 19, 2017

Record last verified: 2015-06

Locations

GB(1)NL(1)