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)
- Conditions
- eye cancerocular or choroidal melanoma10030054
- Registration Number
- NL-OMON44683
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
1.Clinical diagnosis of metastatic uveal melanoma
2.Written consent from female or male patients aged 18 years or older
3.Histological or cytological confirmation of melanoma who are suitable
for treatment with dacarbazine chemotherapy
4.At least one lesion that can be accurately measured at baseline as >=10
mm 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
5.Patients should be able to swallow selumetinib/placebo capsules
Patients should not enter the study if any of the following exclusion criteria are fulfilled:;1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site);2. Previous randomisation in the present study;3. Patients cannot have been previously treated with a systemic anti-cancer therapy. Patients can have prior intra-hepatic or non-systemic therapy;4. 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 halflives 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.;5. Any unresolved toxicity >CTCAE grade 2 from previous anti-cancer therapy, excluding alopecia;6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib or dacarbazine;7. 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);8. 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 below the LLN (defined for this protocol as <55% on
echocardiography or institution*s LLN for MUGA)
* 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;9. 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);10. Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption;11. 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;12. Ophthalmologic conditions:
* Current or past history of retinal pigment epithelial detachment
(RPED)/central serous retinopathy
* Current or past history of retinal vein occlusion
* IOP >21 mmHg or uncontrolled glaucoma (irrespective of IOP);13. Female patients who
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression Free Survival (PFS) using blinded independent central review (BICR)<br /><br>according to RECIST 1.1</p><br>
- Secondary Outcome Measures
Name Time Method