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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors, Thyroid Cancer, Soft-tissue Sarcoma, Cholangiocarcinoma

Thank you

Trial Information

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


Inclusion Criteria:



- Dose escalation cohort for all solid tumors is complete and closed to enrollment. For
the expansion cohorts, patients must have: advanced, inoperable differentiated
thyroid cancer (DTC), soft-tissue sarcoma or cholangiocarcinoma. 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

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

Outcome Time Frame:

Approximately one year

Safety Issue:

Yes

Principal Investigator

Nilo Azad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Food and Drug Administration

Study ID:

J1162

NCT ID:

NCT01438554

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Solid Tumors
  • Thyroid Cancer
  • Soft-Tissue Sarcoma
  • Cholangiocarcinoma
  • Thyroid Neoplasms
  • Thyroid Diseases
  • Cholangiocarcinoma
  • Neoplasms
  • Sarcoma

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410