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Tyrosine Kinase Inhibitor

Temozolomide and Pazopanib Hydrochloride in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors That Cannot Be Removed By Surgery

Phase 1 & 2
Waitlist Available
Led By Halla Nimeiri
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after every 2 cycles of treatment (8 weeks) and up to 60 months
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This phase I/II trial studies the side effects and best dose of temozolomide and pazopanib hydrochloride when given together and to see how well they work in treating patients with advanced pancreatic neuroendocrine tumors (PNET) that cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth. Giving temozolomide together with pazopanib hydrochloride may be an effective treatment for patients with PNET.

Eligible Conditions
  • Pancreatic Cancer
  • Pancreatic Neuroendocrine Tumors
  • Pancreatic Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after every 2 cycles of treatment (8 weeks) and up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and after every 2 cycles of treatment (8 weeks) and up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the Maximum Tolerated Dose (MTD) of Temozolomide in Combination With 400 mg Pazopanib in Patients With Advanced Pancreatic Neuroendocrine Tumor (PNET) in Phase I
Overall Response Rate (ORR) in Patients With Advanced Neuroendocrine Tumors (PNET) Treated With Temozolomide and Pazopanib Combination Treatment at the RP2D in Phase II
Secondary study objectives
Number of Months That Patients Maintain a Response to Treatment Until Disease Progression or Death (Duration of Response)
Number of Patients Experiencing Response to Treatment or Stable Disease (Disease Control Rate)
Number of Patients Who Experience Toxicity Events Undergoing This Treatment.
+3 more
Other study objectives
Amount of a Particular Tumor Biomarker in Blood as Correlated With Progression Free Survival
Determine the Relationship Between Tumor Blood Flow and Overall Response Rate

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Temozolomide 75 mg/m2 and Pazopanib 400 mgExperimental Treatment2 Interventions
Temozolomide 75 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28
Group II: Temozolomide 150 mg/m2 and Pazopanib 400 mgExperimental Treatment2 Interventions
Temozolomide 150 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28
Group III: Temozolomide 100 mg/m2 and Pazopanib 400 mgExperimental Treatment2 Interventions
Temozolomide 100 mg/m2 on days 1-7 and 15-21 , Pazopanib 400 mg on days 1-28
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
FDA approved
Pazopanib
FDA approved

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,813 Previous Clinical Trials
8,382,607 Total Patients Enrolled
Robert H. Lurie Cancer CenterOTHER
21 Previous Clinical Trials
1,768 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
120 Previous Clinical Trials
7,971 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,650 Previous Clinical Trials
958,776 Total Patients Enrolled
Halla NimeiriPrincipal InvestigatorNorthwestern University
~2 spots leftby Dec 2025
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