Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT)
SUMIT
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)
1 other identifier
interventional
152
11 countries
31
Brief Summary
Selumetinib therapy in patients with metastatic uveal melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2014
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2013
CompletedFirst Posted
Study publicly available on registry
November 4, 2013
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedResults Posted
Study results publicly available
September 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJanuary 5, 2017
January 1, 2017
1.1 years
October 10, 2013
May 9, 2016
January 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (3)
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
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
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
From Randomization, up until death assessed up to 15th May 2015
Study Arms (2)
selumetinib 75mg twice daily
EXPERIMENTALselumetinib 75mg twice daily in combination with dacarbazine.
placebo twice daily
PLACEBO COMPARATORplacebo twice daily in combination with dacarbazine.
Interventions
selumetinib tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
placebo tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (31)
Research Site
Los Angeles, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Atlanta, Georgia, United States
Research Site
Lutherville, Maryland, United States
Research Site
St Louis, Missouri, United States
Research Site
New York, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Edegem, Belgium
Research Site
Ghent, Belgium
Research Site
Kortrijk, Belgium
Research Site
Leuven, Belgium
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Olomouc, Czechia
Research Site
Prague, Czechia
Research Site
Hus, Finland
Research Site
Nice, France
Research Site
Paris, France
Research Site
Heidelberg, Germany
Research Site
München, Germany
Research Site
Jerusalem, Israel
Research Site
Ramat Gan, Israel
Research Site
Leiden, Netherlands
Research Site
Barcelona, Spain
Research Site
L'Hospitalet de Llobregat, Spain
Research Site
Seville, Spain
Research Site
Valencia, Spain
Research Site
Glasgow, United Kingdom
Research Site
Northwood, United Kingdom
Research Site
Nottingham, United Kingdom
Research Site
Swansea, United Kingdom
Related Publications (2)
Carvajal RD, Piperno-Neumann S, Kapiteijn E, Chapman PB, Frank S, Joshua AM, Piulats JM, Wolter P, Cocquyt V, Chmielowski B, Evans TRJ, Gastaud L, Linette G, Berking C, Schachter J, Rodrigues MJ, Shoushtari AN, Clemett D, Ghiorghiu D, Mariani G, Spratt S, Lovick S, Barker P, Kilgour E, Lai Z, Schwartz GK, Nathan P. Selumetinib in Combination With Dacarbazine in Patients With Metastatic Uveal Melanoma: A Phase III, Multicenter, Randomized Trial (SUMIT). J Clin Oncol. 2018 Apr 20;36(12):1232-1239. doi: 10.1200/JCO.2017.74.1090. Epub 2018 Mar 12.
PMID: 29528792DERIVEDCarvajal RD, Schwartz GK, Mann H, Smith I, Nathan PD. Study design and rationale for a randomised, placebo-controlled, double-blind study to assess the efficacy of selumetinib (AZD6244; ARRY-142886) in combination with dacarbazine in patients with metastatic uveal melanoma (SUMIT). BMC Cancer. 2015 Jun 10;15:467. doi: 10.1186/s12885-015-1470-z.
PMID: 26059332DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Karin Bowen
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2013
First Posted
November 4, 2013
Study Start
April 1, 2014
Primary Completion
May 1, 2015
Study Completion
October 1, 2016
Last Updated
January 5, 2017
Results First Posted
September 28, 2016
Record last verified: 2017-01