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

NCT01221506 | Completed Early Phase 1 DMC

• 1 other identifier: UPCC 34809
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Carcinoma, Renal Cell

Keywords

unresectable; metastatic; clear cell renal carcinoma

Outcome Measures

Primary Outcomes (1)

• Evaluate Early Changes in DCE-MRI

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

  12 weeks

Secondary Outcomes (1)

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

Interventions

Pazopanib DRUG

800 mg PO QD x 28 days

DCE-MRI and Quantitative Doppler Ultrasound DEVICE

Contrast-enhanced MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

pazopanib; Dynamic Contrast Enhanced Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Naomi Haas, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 15, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: April 1, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

US (1)