SARC029: Trametinib and Pazopanib in Patients With GIST (Gastrointestinal Stromal Tumor)

NCT02342600 | Withdrawn Phase 2

• 1 other identifier: SARC029
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the combination of trametinib and pazopanib in patients with advanced gastrointestinal stromal tumors (GIST).

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  Disease Control Rate (DCR) is the percentage of patients who have achieved complete response, partial response and stable disease to study treatment

  16 weeks

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  Up to 12 months

• Overall Survival (OS)

  up to 10 years

• Number and type of adverse events

  up to 2 years

Study Arms (1)

Trametinib with Pazopanib

EXPERIMENTAL

Participants will take pazopanib (800mg) and trametinib (2mg) by mouth daily for a 28 day cycle.

Drug: Pazopanib; Drug: Trametinib

Interventions

Pazopanib DRUG

A kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma and advanced soft tissue sarcoma who have receive prior chemotherapy.

Also known as: Votrient

Trametinib with Pazopanib

Trametinib DRUG

A kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

Also known as: Mekinist

Trametinib with Pazopanib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Histologically confirmed diagnosis of advanced GIST
• ECOG performance status of 0-1
• Measurable disease as per modified RECIST 1.1
• Prior disease progression on at least imatinib and sunitinib. Maximum of 3 prior kinase inhibitors allowed for treatment of advanced disease. Patients with prior exposure to pazopanib or MEK inhibitors are not eligible.
• Adequate organ systems function within 14 days (and 72 hours) prior to start of protocol therapy
• Patients must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
• Women of childbearing potential must have a negative urine or blood pregnancy test within 7 days of Cycle 1 Day 1. Fertile men and women of childbearing potential must agree to use effective contraception as defined in Section 7 during the study and for 4 months following the last dose of study drugs in both sexes.
• Life expectancy of ≥ 3months

You may not qualify if:

• Prior malignancy.
• Central nervous system (CNS) metastases at baseline, with the exception of those patients who have previously-treated CNS metastases (surgery +/- radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria:
• are asymptomatic and have no requirement for steroids or enzyme-inducing anticonvulsants in at least 3 months prior to screening.
• Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
• QTcB interval \> 480 msec
• History of one or more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting Myocardial infarction Unstable angina Coronary artery bypass graft surgery Symptomatic peripheral vascular disease Class II, III, or IV congestive heart failure, as defined by the New York Heart Association (NYHA) Uncontrolled arrhythmias
• Poorly controlled hypertension \[defined as systolic blood pressure (SBP) of ≥ 140 mm Hg or diastolic blood pressure (DBP) of ≥ 90 mmHg\].
• History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
• Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement are not considered to be major surgery).
• Evidence of active bleeding or bleeding diathesis.
• Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.
• Recent hemoptysis (≥ 1/2 teaspoon of red blood within 8 weeks before first dose of study drug)
• Any serious and or unstable pre-existing medical, psychiatric, or other condition that could interfere with the patient's safety, provision of informed consent, or compliance to study procedures.

Sponsors & Collaborators

• Sarcoma Alliance for Research through Collaboration: lead
• Novartis: collaborator

Related Links

• Sarcoma Alliance for Research through Collaboration

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

pazopanib; trametinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Kristen Ganjoo, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 21, 2015
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Last Updated: October 12, 2017

Record last verified: 2017-03