AzTrials
AzTrials

Gastrointestinal Stromal TumorsPhase 2NCT02342600

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

A Phase 2 study testing Pazopanib and Trametinib in people with Gastrointestinal Stromal Tumors, run by Sarcoma Alliance for Research through Collaboration.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Stromal Tumors
What is being tested?
Pazopanib and Trametinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2017to Jan 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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.
  • Unable or unwilling to discontinue use of prohibited medications listed in Section 5.2.4 for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.
  • Treatment with any of the following anti-cancer therapies:
  • Radiation therapy or tumor embolization within 14 days prior to the first dose of OR
  • Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug.
  • Ipilimumab must have been discontinued at least 8 weeks prior to initiation of treatment with trametinib
  • Administration of any non-oncologic investigational drug within 30 days or five half-lives (whichever is longer) prior to the first dose of study drug.
  • Any ongoing toxicity from prior anti-cancer therapy that is ≥ Grade 1 and/or that is progressing in severity, except alopecia.
  • Inability to swallow and retain oral medication
  • Known or suspected allergy or hypersensitivity to pazopanib, trametinib (GSK1120212), or excipients of the formulations given during the course of this trial.
  • History of interstitial lung disease or pneumonitis, intracardiac defibrillators, known HIV, active HBV or HCV infections, history of retinal vein occlusion, symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression.

About this study

Official title: SARC029: Phase II Pilot Study of Trametinib in Combination With Pazopanib in Patients With Metastatic or Local-regionally Recurrent GIST (Gastrointestinal Stromal Tumor) Refractory or Intolerant to at Least Imatinib and Sunitinib

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

Read the detailed description

Trametinib and pazopanib are independently approved for other cancers. Both drugs work to inhibit tumor development in different ways. Combining these drugs may lead to improved disease control. The purpose of this study is to evaluate the effect of the combination of both drugs on advanced gastrointestinal stromal tumors.

Being tested
Pazopanib, Trametinib
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PazopanibDrug

    Also called Votrient

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

  • TrametinibDrug

    Also called Mekinist

    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.

Study groups in NCT02342600
Study groupRoleWhat they receive
Trametinib with PazopanibExperimentalParticipants will take pazopanib (800mg) and trametinib (2mg) by mouth daily for a 28 day cycle.
Receives: Drug: Pazopanib; Drug: Trametinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 16 weeks

Secondary outcomes (3)

  1. Progression Free Survival (PFS)

    Date of first dose of drug to date of imaging demonstrating disease progression.

    Measured: Up to 12 months

  2. Overall Survival (OS)

    Time from first date of drug administration to date of death from any cause

    Measured: up to 10 years

  3. Number and type of adverse events

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2015 (estimated)
  2. Study startJan 2017
  3. Primary completionJan 2020 (estimated)

Why it stopped: Supporting company withdrew interest

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02342600
Sponsor's protocol ID
SARC029
Status last verified
Mar 2017
First submitted
15 Jan 2015
Last updated
12 Oct 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pazopanib and Trametinib in people with Gastrointestinal Stromal Tumors, run by Sarcoma Alliance for Research through Collaboration.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (DCR) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02342600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in