AzTrials
AzTrials

Sarcoma,Soft TissuePhase 1PASART-1NCT01985295

Combined Modality Treatment of Sarcomas of the Extremities

A Phase 1 study testing pazopanib in people with Sarcoma,Soft Tissue, run by The Netherlands Cancer Institute at 1 site in Netherlands.

Completed

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

Official record
Search all trials

Trial summary

In this study, we aim to define the recommended dose of a VEGFR-TKI (pazopanib) in combination with RT pre-operatively given. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma,Soft Tissue
What is being tested?
pazopanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteNetherlands
Study dates
Jun 2010to Nov 2014
Phase
Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed newly diagnosed intermediate to high grade soft tissue sarcoma of and localized to the extremities or head and neck area for which the treatment is a combination of both surgery and radiotherapy (deep seated, > 5cm according to the RECIST 1.1 criteria, grade II/III according to the WHO definition).
  • Age > 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
  • 6 Able to swallow and retain oral medication. 7. A life expectancy of at least 12 weeks. 8. Adequate organ function.
  • -

Who cannot join

  • Prior malignancies; except subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
  • Patients with recurrent sarcomas (even without prior radiotherapy).
  • Ewing sarcoma and other PNET family tumours, rhabdomyosarcomas (both pediatric and adult), osteosarcomas.
  • Clinically significant gastrointestinal abnormalities which might interfere with oral dosing diagnosed as:
  • Active peptic ulcer disease.
  • Known intraluminal metastatic lesions with suspected bleeding.
Show all 31Show fewer
  • Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation.
  • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
  • Major resection of the stomach or small bowel.
  • Uncontrolled hypertension.
  • Unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).
  • Prolongation of corrected QT interval (QTc) >480 msecs.
  • History of any one of more of the following cardiovascular conditions within the past 6 months:
  • Cardiac angioplasty or stenting.
  • Myocardial infarction.
  • Unstable angina.
  • Symptomatic peripheral vascular disease.
  • Coronary artery by-pass graft surgery.
  • Class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA).
  • History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • Macroscopic hematuria
  • Haemoptysis that is clinically relevant within 4 weeks of first dose of study drug.
  • Evidence of active bleeding or bleeding diathesis.
  • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
  • Chemotherapy or radiation therapy within 2 weeks prior to the first dose of study drug.
  • Biological therapy or treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer prior to the first dose of study drug.
  • Prohibited medications listed in the protocol for 14 days or five half-lives of a drug (whichever is longer) prior to Visit 1 and for the duration of the study should not be taken.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
  • Pregnancy or lactating.
  • Hypothyroidism.
  • -

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • The Netherlands Cancer Institute

    Amsterdam, North Holland, 1066CX

Other trials in Netherlands

About this study

Official title: Phase I Clinical Study of a Combined Modality Treatment of Sarcomas of the Extremities With Radiotherapy (RT) and Dose-escalation of Pazopanib

In this study, we aim to define the recommended dose of a VEGFR-TKI (pazopanib) in combination with RT pre-operatively given.

Read the detailed description

Study design A dose escalation trial of Pazopanib, starting at 400mg daily, orally in combination with the standard 25 x 2Gy preoperative radiotherapy in newly diagnosed extremity sarcoma patients. Dose of pazopanib will be escalated via 600mg to maximally 800mg. Overall treatment time of pazopanib is 40 days.

Treatment plan: Pazopanib Dose level Dose of pazopanib orally, once daily, # patients

  1. (starting) 400 mg 3
  2. 600 mg 3
  3. (maximum) 800 mg 3

Treatment plan: radiotherapy RT is given during 5 weeks with a once daily fraction of 2 Gray (50 Gray in 25 daily fractions)

RT planning: The dose planning should be performed by CT based Intensity Modulated RT (IMRT) or 3 Dimensional Conformal RT (3D-RT) according to the local planning protocol of the participating institute.

Dose specification: According to the ICRU 50/62.

Being tested
pazopanib
Medical subject headings
Sarcoma

What participants receive

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

  • pazopanibDrug

    Also called Compound Number: GW786034

    A dose escalation trial of Pazopanib, starting at 400mg daily, orally in combination with the standard 25 x 2Gy preoperative radiotherapy in newly diagnosed extremity sarcoma patients. Dose of pazopanib will be escalated via 600mg to maximally 800mg. Overall treatment time of pazopanib is 40 days.

Study groups in NCT01985295
Study groupRoleWhat they receive
cohortOtherDose level Dose of pazopanib orally, once daily, # patients -1 200 mg -- 1. (starting) 400 mg 3 2. 600 mg 3 3. (maximum) 800 mg 3
Receives: Drug: pazopanib

What is being measured

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

  1. Dose limiting toxicity

    To study the safety and feasibility of adding 6 weeks of orally administered Pazopanib to 25 x 2Gy in 5 weeks preoperative radiotherapy in extremity or head and neck area soft tissue sarcoma patients (to identify the Dose Limiting Toxicity (DLT) and the Recommend Phase II Dose (RPTD) if pazopanib is added to 50 Gy pre-operatively)

    Measured: 14 weeks

Secondary outcomes (1)

  1. the exploration/feasibility of dynamic imaging

    The secondary objective is to explore the feasibility to perform perfusion weighted MRI imaging regarding tumor respons to RT and neoangio genesis inhibitor by pazopanib.

    Measured: 14 weeks

Timeline

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

  1. First posted15 Nov 2013 (estimated)
  2. Study startJun 2010
  3. Primary completionAug 2014
  4. Study completionNov 2014

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01985295
Sponsor's protocol ID
M09RTP
Other IDs
2009-014901-15, 2009
Acronym
PASART-1
Status last verified
Oct 2015
First submitted
7 Oct 2013
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing pazopanib in people with Sarcoma,Soft Tissue, run by The Netherlands Cancer Institute at 1 site in Netherlands.

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 7 inclusion and 31 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 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Dose limiting toxicity (time frame: 14 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 NCT01985295.

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 9 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in