Continuous selumetinib versus continuous or interrupted selumetinib in comb... | Recruiting
Continuous selumetinib versus conti... | Recruiting
Continuous selumetinib versus continuous or interrupted selumetinib in combination with weekly paclitaxel in metastatic uveal melanoma
SelPac

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Medical Conditions
  • Topic: Cancer
  • Subtopic: Melanoma
  • Disease: Melanoma
Primary Contact Details
Miss Louise Handley
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN29621851
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-selumetinib-and-paclitaxel-for-a-type-of-eye-cancer-called-uveal-melanoma-selpac
Research Details
  • This study aims to compare continuous single agent selumetinib to combination paclitaxel and selumetinib in either a continuous or intermittent schedule.
Phase
Phase II
Study Design
Randomised; Interventional; Design type: Treatment
Study Type
Interventional
Intervention

1. Paclitaxel, IMP
2. Selumetinib, IMP

Intervention Type
Other
Primary Outcome Measures
    Progression Free Survival (PFS) time.; Timepoint(s): Progression
Secondary Outcome Measures
    1. GNAQ/GNA11 mutation status
    2. RECIST Response
    3. Safety and toxicity
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 123; UK Sample Size: 123; Description: 123 evaluable patients will be randomised to arms A, B and C across 13 UK centres. Subjects will be randomised 1:1:1 between the 3 arms.
Participant Inclusion Criteria
    Histologically or cytologically confirmed metastatic uveal melanoma
    1. Patients must have measurable disease, defined by RECIST 1.1
    2. Age at least18 years
    3. ECOG performance status 0­2
    4. Life expectancy of greater than 3 months
    5. Able to swallow and retain orally­administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
    6. All prior treatment­related toxicities must be CTCAE v4 grade = 1 (except alopecia) at the time of randomization
    7. Laboratory values as listed below (SI units):
    7.1. Total bilirubin = 1.5 X institutional upper limit of normal (ULN)
    7.2. Aspartate aminotransferase or alanine aminotransferase >2.5 x ULN (or =5 ULN in presence of liver metastases)
    7.3. Haemoglobin =9.0 g/dL
    7.4. Platelets >100x109/L (100,000 per mm3)
    7.5. Absolute neutrophil count >1.5x109/L (1500 per mm3)
    7.6. Creatinine = 1.5 mg/dL OR calculated creatinine clearance (Cockroft­Gault formula) =50 mL/min OR 24­hour urine creatinine clearance =50 mL/min
    8. Female patients of child­bearing potential should have a negative pregnancy test
Participant Exclusion Criteria
    1. Patients may not have received prior chemotherapy for uveal melanoma. This includes patients who have received isolated hepatic perfusion of chemotherapy. Patients who have received prior immunotherapy or non­chemotherapy locoregional therapy for liver metastases, but who have documented evidence of progression of metastatic disease would however be eligible
    2. Patients who have a known or suspected brain metastases or spinal cord compression, unless asymptomatic, has been treated with surgery and / or radiation, and has been stable without requiring corticosteroids nor anti­convulsant medications for at least 4 weeks prior to the first dose of study medication
    3. Prior exposure to MEK, Ras, or Raf inhibitors or history of hypersensitivity to any excipient agents.
    4. History of another malignancy unless disease­free for 3 years. Patients, who have had a completely resected nonmelanoma skin cancer, are eligible
    5. Any permitted previous treatment must have been greater than 21 days prior to study treatment starting and all toxicities from previous treatments should have resolved
    6. Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Treated brain metastases must have been stable for at least 1 month
    7. Current use of a prohibited medication
    8. Cardiac conditions as follows:
    8.1. Uncontrolled hypertension (BP =150/95 mmHg despite medical therapy)
    8.2. Acute coronary syndrome within 6 months prior to starting treatment
    8.3. Baseline Left ventricular ejection fraction (LVEF) below the LLN or <55% measured by echocardiography or institution’s LLN for MUGA
    8.4. Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest
    8.5. Symptomatic heart failure NYHA Class II­IV, prior or current cardiomyopathy, or severe valvular heart disease
    8.6. Prior or current cardiomyopathy including but not limited to the following:
    8.7. Known hypertrophic cardiomyopathy
    8.8. Known arrhythmogenic right ventricular cardiomyopathy
    8.9. Previous moderate or severe impairment of left ventricular systolic function (LVEF <45% on echocardiography or equivalent on MuGA) even if full recovery has occurred
    8.10.Uncontrolled angina (Canadian Cardiovascular Society grade II­IV despite medical therapy)
    8.11. Acute coronary syndrome within 6 months prior to starting treatment
    8.12. QTcF >450ms or other factors that increase the risk of QT prolongation
    9. Ophthalmological conditions as follows (unless in the eye involved by uveal melanoma):
    9.1. Intra­ocular pressure >21 mmHg, or uncontrolled glaucoma (irrespective of intra­ocular pressure)
    9.2. Current or past history of retinal pigment epithelial detachment (RPED)/central serous retinopathy(CSR) or retinal vein occlusion
    10. Uncontrolled intercurrent illness or uncontrolled systemic disease including, but not limited to, ongoing or active infection – including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), symptomatic congestive heart failure, unstable/uncontrolled angina pectoris, uncontrolled cardiac arrhythmia, QTc prolongation, active bleeding diatheses, renal transplant or psychiatric illness/social situations that would limit compliance with study requirements
    11. Female patients who are breast­feeding
    12. Male or female patients of reproductive potential who are not employing an effective method of contraception
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Liverpool
L69 3GL
Trial Contact(s)
Primary Trial Contact
Miss Louise Handley
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A randomised three arm, open label, phase II study of continuous selumetinib versus continuous or interrupted selumetinib in combination with weekly paclitaxel in metastatic uveal melanoma
EudraCT Number
2014-004437-22
Funder(s)
  • AstraZeneca
Other Study ID Numbers
19090
Sponsor(s)
University of Liverpool
Key Dates

Recruitment Start Date

01 Aug 2015

Recruitment End Date

01 Feb 2018

Trial Start Date

01 Aug 2015

Trial End Date

01 Feb 2018

Date added to source

17 Jun 2015

Date updated in source

02 Feb 2016