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Completed

NCT Number: NCT01438554

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

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.

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Key information

Conditions

Solid Tumors Adenocarcinoma Carcinoma Cholangiocarcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Glandular and Epithelial Sarcoma Soft-Tissue Sarcoma Thyroid Cancer Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase risk of pulmonary hemorrhage.
  • Hemoptysis within 6 months of starting treatment.
  • History of retinal vein occlusion (RVO) or central serous retinopathy (CSR), or predisposing factors to RVO or CSR as assessed by ophthalmic exam.
  • Known brain mets that are not stable for at least 8 weeks prior to treatment, or patient is on glucocorticoids for brain mets.

Treatment and study plan

Pazopanib

Drug

Other names: Votrient

GSK1120212

Drug

Other names: Trametinib, Mekinist

Primary outcomes

  1. Maximum tolerated dose (MTD) of pazopanib and GSK1120212 when combined in patients with solid tumors

    Time frame: Approximately one year

  2. Adverse events as a measure of the safety and tolerability profile of pazopanib in combination with GSK1120212 in patients with solid tumors

    Time frame: Approximately two years

Secondary outcomes

  1. Objective response rate at six months in patients with advanced thyroid cancer, soft tissue sarcoma and cholangiocarcinoma being treated at the MTD

    Time frame: Approximately one year

  2. Progression-free survival (PFS) in patients with advanced thyroid cancer, soft tissue sarcoma and cholangiocarcinoma being treated at MTD.

    Time frame: Approximately one year

  3. Correlation of PK data with radiographic response, PD markers, and the impact of tumor histologic subtype and tumor genotype on radiographic response for patients with advanced thyroid cancer

    Time frame: Approximately one year

  4. PD marker analysis on peripheral blood mononuclear cells for patients with soft tissue sarcoma and cholangiocarcinoma

    Time frame: Approximately one year

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Comprehensive Cancer Network
  • Novartis

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2018
First posted
Sep 22, 2011
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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