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
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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