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Phase 1 Study of Pazopanib With GSK1120212 in Advanced Solid Tumors, Enriched With Patients With Differentiated Thyroid Cancer, Soft-tissue Sarcoma, and Cholangiocarcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Phase 1 Study of Pazopanib With GSK1120212 in Advanced Solid Tumors, Enriched With Patients With Differentiated Thyroid Cancer, Soft-tissue Sarcoma, and Cholangiocarcinoma

Phase I Study Determining the Safety and Tolerability of Combination Therapy With Pazopanib, a VEGFR/PDGFR/Raf Inhibitor, and GSK1120212, a MEK Inhibitor, in Advanced Solid Tumors Enriched With Patients With Advanced Differentiated Thyroid Cancer, Soft Tissue Sarcoma, and Cholangiocarcinoma

NCT01438554•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and toxicity of the combination of pazopanib and GSK1120212 in patients with solid tumors and identify the maximum tolerated dose (MTD) of this combination for phase II study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Dose escalation cohort for all solid tumors is closed to enrollment.
•Expansion cohorts: Soft-tissue sarcoma, cholangiocarcinoma, and differentiated thyroid cancer (DTC) cohorts are closed to enrollment. Patients in the DTC cohort must have disease that is able to be biopsied.
•Must have measurable disease.
•Tumor progression in the 6-month period prior to study drug initiation.
•DTC patients: must have radioiodine non-avid lesions, OR radioiodine avid lesions that have not responded to treatment with radioactive iodine.
•ECOG performance status less than or equal to 1.
•Life expectancy \>3 months.
•Blood pressure \<140 mmHg and \<90 mmHg.
•LVEF is \>= 50%
•Must be able to swallow pills.

Exclusion Criteria

•Chemotherapy, radiotherapy, other investigational therapy, or major surgery within 4 weeks.
•Sarcoma and cholangiocarcinoma ONLY: Prior VEGF-targeted TKI therapy.
•Pregnant or currently breastfeeding.
•Unresolved toxicity greater than grade 1.
•Evidence of active hepatitis or HIV.
•Significant cardiovascular disease.
•Taking medications known to be strong inducers or inhibitors of CYP3A enzymes.
•Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
•History of gastrointestinal condition causing malabsorption or obstruction.
•Cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT) within past 6 months.
+4 more criteria

Locations (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

October 1, 2011

Primary Completion Date

April 1, 2016

Completion Date

August 1, 2018

Last Updated

August 29, 2018

Enrollment

ACTUAL participants

Conditions

Solid TumorsThyroid CancerSoft-tissue SarcomaCholangiocarcinoma

Interventions

Pazopanib

DRUG

GSK1120212

DRUG

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

NCT06316895

Papillary Thyroid Cancer

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RECRUITINGPHASE1/PHASE2

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 1 Study of Pazopanib With GSK1120212 in Advanced Solid Tumors, Enriched With Patients With Differentiated Thyroid Cancer, Soft-tissue Sarcoma, and Cholangiocarcinoma

Inclusion Criteria

Exclusion Criteria

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

A Study of ASP1002 in Adults for Treatment of Solid Tumors

S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors

Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)