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

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Brief Title

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

Official Title

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)

Brief Summary

      Selumetinib therapy in patients with metastatic uveal melanoma.
    

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

 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

Condition

Metastatic

Intervention

75mg selumetinib

Study Arms / Comparison Groups

 selumetinib 75mg twice daily
Description:  selumetinib 75mg twice daily in combination with dacarbazine.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

152

Start Date

April 2014

Completion Date

October 2016

Primary Completion Date

May 2015

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 130 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT01974752

Organization ID

D1344C00001


Responsible Party

Sponsor

Study Sponsor

AstraZeneca


Study Sponsor

, , 


Verification Date

January 2017