Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) (SUMIT)

January 4, 2017 updated by: AstraZeneca

A Randomised, Double-Blind Study to Assess the Efficacy of Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine as First Systemic Therapy in Patients With Metastatic Uveal Melanoma (SUMIT)

Selumetinib therapy in patients with metastatic uveal melanoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomised double-blind study to assess the efficacy of selumetinib (AZD6244, Hyd-Sulfate) in combination with Dacarbazine compared with placebo in combination with Dacarbazine as first systemic therapy in patients with metastatic uveal melanoma (SUMIT)

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Kortrijk, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
  • Czech Republic
      • Olomouc, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
  • Finland
      • Hus, Finland
        • Research Site
  • France
      • Nice Cedex 2, France
        • Research Site
      • Paris Cedex 5, France
        • Research Site
  • Germany
      • Heidelberg, Germany
        • Research Site
      • München, Germany
        • Research Site
  • Israel
      • Jerusalem, Israel
        • Research Site
      • Ramat Gan, Israel
        • Research Site
  • Netherlands
      • Leiden, Netherlands
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • L'Hospitalet de Llobregat, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
  • United Kingdom
      • Glasgow, United Kingdom
        • Research Site
      • Northwood, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Swansea, United Kingdom
        • Research Site
  • United States
    • California
      • Los Angeles, California, United States
        • Research Site
    • Colorado
      • Aurora, Colorado, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Maryland
      • Lutherville, Maryland, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • New York
      • New York, New York, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Clinical diagnosis of metastatic uveal melanoma; Written consent from female or male patients aged 18 years and over. Histological or cytological confirmation of melanoma who are suitable for treatment with dacarbazine chemotherapy.

  • At least one lesion that can be accurately measured at baseline as>/=10mm in the longest diameter. (except lymph nodes which must have short axis ≥15 mm) with CT or MRI and which is suitable for accurate repeated measurements
  • ECOG performance status 0-1
  • life expectancy >12 weeks
  • Normal organ and marrow function
  • Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients
  • Patients should be able to swallow selumetinib/placebo capsules

Exclusion Criteria:-Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)

  • Previous randomisation in the present study
  • Patients cannot have previously been treated with a systemic anti-cancer therapy. Patients can have prior intra-hepatic or non-systemic therapy. -Having received any of the following within the specified timeframe:

Any prior systemic anti-cancer therapy for the treatment of this current diagnosis, An investigational drug within 30 days of starting treatment or within five half-lives of the compound (whichever is the most appropriate is at the discretion of the Investigator), or have not recovered from side effects of an investigational drug Any non-systemic anti-cancer therapy which has not been cleared from the body by the time of starting study treatment Radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment Major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) which would prevent administration of study treatment, Any prior investigational therapy comprising inhibitors of RAS, RAF or MEK at any time, Previous treatment with dacarbazine. Any unresolved toxicity >CTCAE grade 2 from previous anti-cancer therapy, excluding alopecia -History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib or dacarbazine

--Symptomatic brain metastases or spinal cord compression (patients must be treated and stable off steroids and anti-convulsants for at least 1 month prior to entry into the study)

Cardiac conditions as follows:

  • Uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy)
  • Acute coronary syndrome within 6 months prior to starting treatment
  • Uncontrolled Angina - Canadian Cardiovascular Society grade II-IV despite medical therapy - Symptomatic heart failure (New York Heart Association [NYHA] Class II-IV,- Prior or current cardiomyopathy
  • Baseline LVEF <55% measured by echocardiography or MUGA. Appropriate correction to be used if a MUGA is performed
  • Severe valvular heart disease
  • Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest
  • QTcF >450 ms or other factors that increase the risk of QTc prolongation
  • Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
  • Refractory nausea and vomiting, chronic gastrointestinal diseases (eg inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
  • History of another primary malignancy within 5 years prior to starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study
  • Ophthalmologic conditions:
  • Current or past history of central serous retinopathy
  • Current or past history of retinal vein occlusion
  • IOP >21 mmHg or uncontrolled glaucoma (irrespective of IOP)
  • Female patients who are breast-feeding a child and male or female patients of reproductive potential who are not employing an effective method of birth control
  • Clinical judgement by the Investigator that the patient should not participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: selumetinib 75mg twice daily
selumetinib 75mg twice daily in combination with dacarbazine.
Drug: 75mg selumetinib
selumetinib tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
Drug: Dacarbazine
dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle taken in combination with either selumetinib or placebo tablets p.o. twice daily.
Placebo Comparator: placebo twice daily
placebo twice daily in combination with dacarbazine.
Drug: Dacarbazine
dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle taken in combination with either selumetinib or placebo tablets p.o. twice daily.
Drug: placebo
placebo tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1.
Time Frame: From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015
Progression free survival (PFS) using blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR
Time Frame: From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015
ORR at Week 6 using BICR according to RECIST 1.1
From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015
Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR
Time Frame: From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015
Percent change in tumour size at Week 6 using BICR according to RECIST 1.1
From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015
Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine
Time Frame: From Randomization, up until death assessed up to 15th May 2015
Overall Survival
From Randomization, up until death assessed up to 15th May 2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Estimate)

January 5, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1344C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uveal Melanoma

Clinical Trials on 75mg selumetinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe