AzTrials
AzTrials

Carcinoma, Renal CellEarly Phase 1NCT01221506

Pazopanib/DCE-MRIs in Renal Cell Carcinoma (RCC)

A Early Phase 1 study testing Pazopanib and DCE-MRI and Quantitative Doppler Ultrasound in people with Carcinoma, Renal Cell, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

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

All patients who participate in this study will receive pazopanib. Pazopanib is an oral drug (pill) that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced kidney cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Pazopanib and DCE-MRI and Quantitative Doppler Ultrasound
Type of treatment
Medical device
How many people
20 participants
Where
1 siteUnited States
Study dates
Oct 2010to Apr 2019
Phase
Early 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

  • 18 years of age or older
  • Diagnosis of unresectable and/or metastatic clear cell renal cell carcinoma. 10 patients will be enrolled who have had no prior anti-angiogenic therapy; 10 patients will be enrolled who have had one prior anti-angiogenic therapy
  • Prior radiation therapy to a symptomatic site of metastatic disease is allowed but patients must have discontinued/completed radiation therapy at least 2 weeks prior to entering the study, and have recovered from adverse events due to that treatment.
  • ECOG performance status of 0, 1 or 2.
  • Patients must have measureable disease by RECIST 1.1
  • Archived tumor blocks must be provided for all subjects for correlative analysis before or during treatment with pazopanib
Show all 10Show fewer
  • Patient must have normal baseline laboratory values
  • Patients must not receive any other investigational agents while onstudy.
  • Patients must not be taking cytochrome P450 enzyme -inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), rifampin or St.Johns wort.
  • Females of childbearing potential are eligible to enter and participate in this study if they have a negative pregnancy test and agree to use medically accepted contraception throughout the study

Who cannot join

  • Female subjects who are pregnant or brestfeeding - Patients with active prior malignancy. Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
  • Patients with a history or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.
  • Patients with clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
  • Patients with clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
  • Patients the presence of uncontrolled infection.
  • Patient with corrected QT interval (QTc) greater than 480 msecs using Bazetts formula
Show all 17Show fewer
  • Patients with a 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) [See Section YYY Appendix Y for description
  • Patient with poorly controlled hypertension [defined as systolic blood pressure (SBP) of greater or equal to 140 mmHg or diastolic blood pressure (DBP) of greater or equal to 90mmHg].
  • Patients with a history of cerebrovascular accident including transient ischemic attack (TIA),pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
  • Patients who have had 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 (procedures such as catheter placement not considered to be major).
  • Patients who have evidence of active bleeding or bleeding diathesis.
  • Patients with known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
  • Patients with hemoptysis within 6 weeks of first dose of study drug.
  • Patients with any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subjects safety, provision of informed consent, or compliance to study procedures.
  • Patients who are unable or unwilling to discontinue use of prohibited medications list in Section4.3 for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.
  • Treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib; OR chemotherapy,immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days prior to the first dose of pazopanib. Treatment with prior sorafenib, sunitinib, temsirolimus or everolimus is allowed but must be discontinued at least 5 days prior to beginning pazopanib.
  • Patient who have any ongoing toxicity from prior anti-cancer therapy that is greater than Grade 1 and/or that is progressing in severity, except alopecia.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Assessment of Tumor Perfusion Changes in Response to Pazopanib in Renal Cell Carcinoma

All patients who participate in this study will receive pazopanib. Pazopanib is an oral drug (pill) that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced kidney cancer. In this study, the investigators plan to learn more about the way this drug works by using special scans (MRIs and Ultrasounds) to help evaluate how this drug is working on this disease. Approximately 20 people with advanced kidney cancer will be enrolled on this study.

Read the detailed description

Overall objectives PRIMARY: - Assessment of early changes in DCE-MRI and ultrasound measures of tumor perfusion in the setting of pazopanib therapy for patients with metastatic clear cell renal cell carcinoma SECONDARY: - Correlation of baseline DCE-MRI and ultrasound parameters and clinical outcome - Correlation of early (48 +/- 24 hr after treatment) changes in DCE-MRI and ultrasound parameters and clinical outcome - Correlation of baseline (and changes) in DCE-MRI and ultrasound parameters with VHL status in tumors and histocytometric analysis of endothelial cell activation in archival nephrectomy specimens - Provide an insight in the respective predictive values of DCE-MRI and US for pazopanib treatment

Being tested
Pazopanib, DCE-MRI and Quantitative Doppler Ultrasound
Keywords
unresectable, metastatic, clear cell renal carcinoma
Medical subject headings
Carcinoma, Renal Cell, Neoplasm Metastasis

What participants receive

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

  • PazopanibDrug

    800 mg PO QD x 28 days

  • DCE-MRI and Quantitative Doppler UltrasoundDevice

    Contrast-enhanced MRI

What is being measured

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

  1. Evaluate Early Changes in DCE-MRI

    To evaluate early changes in DCE-MRI measures of tumor vascular permeability after treatment with pazopanib.

    Measured: 12 weeks

Secondary outcomes (1)

  1. Correlating Baseline DCE-MRI and early changes in DCE-MRI with other measures of treatment effectiveness

    Correlating baseline DCE-MRI and early changes in DCE-MRI with other measures of treatment effectiveness, including clinical outcomes and histologic measures of tumor angiogenesis.

Timeline

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

  1. First posted15 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionJun 2015
  4. Study completionApr 2019

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221506
Sponsor's protocol ID
UPCC 34809
Status last verified
Mar 2020
First submitted
13 Oct 2010
Last updated
26 Mar 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Pazopanib and DCE-MRI and Quantitative Doppler Ultrasound in people with Carcinoma, Renal Cell, run by Abramson Cancer Center at Penn Medicine at 1 site 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 10 inclusion and 17 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 26 Mar 2020. 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 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Evaluate Early Changes in DCE-MRI (time frame: 12 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 NCT01221506.

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 26 Mar 2020.

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