Study of oral MEK inhibitor Selumetinib (AZD6244 Hyd-Sulphate) in Combinati... | Not Recruiting
Study of oral MEK inhibitor Selumet... | Not Recruiting
Study of oral MEK inhibitor Selumetinib (AZD6244 Hyd-Sulphate) in Combination with highly active AntiRetroviral Therapy (HAART) in AIDS-associated Kaposi’s sarcoma (KS)
SCART

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Medical Conditions
  • Topic: National Cancer Research Network, Infection
  • Subtopic: Sarcoma, Infection (all Subtopics)
  • Disease: Soft Tissue, Infectious diseases and microbiology
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN24921472
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
http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-selumetinib-people-kaposis-sarcoma-scart
Research Details
  • Cancer is a leading cause of death in individuals living with HIV, and Kaposi's sarcoma (KS) remains the commonest HIV-associated cancer. KS results from co-infection with HIV and another virus, HHV-8. Laboratory studies have shown that HHV-8 viral proteins stimulate intracellular signalling pathways within KS lesions which promotes their growth. Selumetinib targets these signalling pathways and may therefore be a useful new therapy for KS.

    SCART is a national multi-centre study. The objectives of the SCART trial are to determine a safe and tolerable dose for selumetinib in combination with HIV anti-retroviral therapy, and to determine whether selumetinib reduces KS lesions in HIV positive patients.

    More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11876
Phase
Phase I/II
Study Design
Non-randomised; Interventional; Design type: Treatment
Study Type
Interventional
Intervention

Selumetinib, Orally bioavailable, selective inhibitor of MEK 1/2, inhibiting the phosphorylation of ERK 1/2

Patients will undergo 6 x 21-day (3-weekly) cycles of treatment. There is a screening visit following by visits every at the end of every cycle. In Phase I during cycle 1 there are weekly visits. Visits involve clinical examination, periodic clinical photographs of lesions, haematology/biochemistry, blood samples taken for translational studies. CT, ECHO or Multi Gated Acquisition Scan (MUGA). Ophthalmologic exam will occur during screening. Further assessments of this nature will only be performed if judged clinically necessary. Patients will have a follow-up visit every 12 weeks for 12 months to record changes in lesions by clinical photographs.

Intervention Type
Drug
Primary Outcome Measures
    Objective response rates; Timepoint(s): Phase I and II
Secondary Outcome Measures
    1. HAART Drug Levels; Timepoint(s): Phase I
    2. HIV control; Timepoint(s): Phase I and II
    3. Number of selumetinib cycles completed; Timepoint(s): Phase I and II
    4. PBMC Sub-study; Timepoint(s): Phase I and II; PD measures of selumetinib in combination with HAART; Timepoint(s): Phase I and II
    5. Progression free survival rate; Timepoint(s): Phase I and II - 6 months post ccompletion of study
    6. Selumetinib and metabolite serum levels; Timepoint(s): phase I
    7. Toxicity; Timepoint(s): Phase I and II
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: 37; UK Sample Size: 37
Participant Inclusion Criteria
    1. Human immunodeficiency virus (HIV) positive and established on a HAART regimen for >=3 months
    2. Histologically confirmed KS
    3. Measurable disease according to AIDS Clinical Trials Group (ACTG) criteria
    4. Evidence of disease progression in the past 6 months, without anticancer treatment since progression
    5. Progressive cutaneous or nodal KS not requiring chemotherapy or progressive KS following cytotoxic chemotherapy
    6. Adequate haematological function:
    6.1. Haemoglobin = 9 g/dL
    6.2. Absolute neutrophil count = 1.5 x 10 9/L
    6.3. Platelets = 100 x 10 9/L
    7. Adequate hepatic function:
    7.1. Serum bilirubin = 1.5 x upper limit of normal (ULN)
    7.2. Alanine aminotransferase (ALT) = 2.5 x ULN
    7.3. Aspartate aminotransferase (AST) = 2.5 x ULN
    8. Adequate renal function:
    8.1. Serum creatinine clearance > 50 ml/min (Cockcroft-Gault formula or 24 hour urine collection)
    8.2. Left ventricular function >50% normal
    9. Age = 18 years.
    10. Eastern Cooperative Oncology Group (ECOG) performance status > 2
    11. For selumetinib, women of child bearing age and child bearing potential must have a negative pregnancy test prior to study entry and be using an adequate contraception method, which must be continued while on treatment and for at least 4 weeks after the study treatment has ended
    12. Male patients must agree to use an effective contraception method while on treatment and for at least 16 weeks after the study treatment has ended (barrier contraception is recommended for all individuals living with HIV).
    13. Written informed consent
Participant Exclusion Criteria
    1. HIV viral load > 200 copies/ml
    2. Any previous treatment with a Ras, Raf or MEK inhibitor
    3. Active opportunistic infections.
    4. Known hepatitis B, hepatitis C
    5. Clinical evidence of uncontrolled hypertension (systolic BP > 150 mmHg or diastolic BP > 90 mmHg on 2 readings = 1 hour apart))
    6. Clinical evidence of heart failure (= New York Heart Association [NYHA] Class II)
    7. Clinical evidence of atrial fibrillation (heart rate > 100 bpm) or unstable ischaemic heart disease (MI within 6 months prior to starting treatment or angina requiring the use of nitrates > once weekly)
    8. Major surgery within 4 weeks prior to starting selumetinib
    9. Evidence of any psychological, familial, sociological or geographical condition potentially hampering protocol compliance
    10. Clinical judgement by the Investigator that the patient should not participate in the study
    11. Refractory nausea, vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption
    12. Treatment with any investigational product within 28 days of registration
    13. Pregnant or breastfeeding women
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)
GSK Investigational Site
London
NW3 2QG
Pfizer Investigational Site
Birmingham
B15 2TT
Trial Contact(s)
Primary Trial Contact
Dr Laura Crack
-
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
Phase I/II study of oral MEK inhibitor Selumetinib (AZD6244 Hyd-Sulphate) in Combination with highly active AntiRetroviral Therapy (HAART) in AIDS-associated Kaposi’s sarcoma (KS)
EudraCT Number
2011-003099-35
Funder(s)
  • Cancer Research UK (CRUK) (UK)
Other Study ID Numbers
11876
Sponsor(s)
Sheffield Teaching Hospitals NHS Trust (UK)
Key Dates

Recruitment Start Date

12 Mar 2012

Recruitment End Date

31 Dec 2016

Trial Start Date

12 Mar 2012

Trial End Date

31 Jan 2018

Date added to source

02 Mar 2012

Date updated in source

10 Oct 2016