Pazopanib Hydrochloride in Treating Patients With Advanced Neuroendocrine Cancer
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|ClinicalTrials.gov Identifier: NCT00454363|
Recruitment Status : Completed
First Posted : March 30, 2007
Results First Posted : April 1, 2015
Last Update Posted : November 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastrin-Producing Neuroendocrine Tumor Lung Carcinoid Tumor Metastatic Digestive System Neuroendocrine Tumor G1 Multiple Endocrine Neoplasia Type 1 Pancreatic Glucagonoma Pancreatic Insulinoma Pancreatic Polypeptide Tumor Recurrent Digestive System Neuroendocrine Tumor G1 Recurrent Pancreatic Neuroendocrine Carcinoma Regional Digestive System Neuroendocrine Tumor G1 Somatostatin-Producing Neuroendocrine Tumor||Other: Laboratory Biomarker Analysis Drug: Pazopanib Hydrochloride Other: Pharmacological Study||Phase 2|
I. To determine the objective response rate (ORR) (complete and partial response) of GW786034 (pazopanib hydrochloride) 800 mg administered orally once daily in patients with advanced low or intermediate grade carcinoid tumors (in carcinoid cohort).
II. To determine the objective response rate (ORR) (complete response and partial response) of GW786034 800mg administered orally once daily in patients with advanced low or intermediate grade pancreatic islet cell carcinoma (in islet cell cohort).
I. To determine the progression free survival (PFS) duration of GW786034 800mg administered orally once daily in patients with low grade neuroendocrine carcinoma.
II. To determine the safety and tolerability of GW786034 800mg administered orally once daily in patients with low grade neuroendocrine carcinoma.
III. To explore the effect on tumor blood flow as determined by functional computed tomography (CT) of GW786034 800 mg orally once daily in patients with low grade neuroendocrine carcinoma.
IV. To assess the trough level of GW786034 800 mg orally once daily in patients with low grade neuroendocrine carcinoma.
Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 90 days for up to 18 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of GW786034 (Pazopanib) in Advanced Low-Grade or Intermediate-Grade Neuroendocrine Carcinoma|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Treatment (pazopanib hydrochloride)
Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Drug: Pazopanib Hydrochloride
Other: Pharmacological Study
- Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 18 months ]RECIST Criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance 1/> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.
- Plasma Trough Level of GW786034 [ Time Frame: Baseline and day 28 ]
- Progression Free Survival (PFS) [ Time Frame: Baseline to 18 months. ]PFS is defined as the duration of time from start of treatment to time of progression or death.
- Change in Tumor Blood Flow Assessed by Functional CT [ Time Frame: Baseline and week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454363
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||James Yao||M.D. Anderson Cancer Center|