A Phase Ib/IIa study of AZD2014 in combination with Selumetinib in patients with advanced cancers. - TORCMEK

Queen Mary University of London0 sites118 target enrollmentFebruary 26, 2015

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Triple-Negative Breast CancerNon-squamous Small Cell Lung CancerSquamous Cell Lung Cancer
Sponsor: Queen Mary University of London
Enrollment: 118
Status: Active, not recruiting
Last Updated: 10 years ago

No summary available.

Registry

who.int

Start Date

February 26, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\) Written informed consent prior to admission to this study
•2\) Age \=18 years
•3\) ECOG performance status 0 or 1
•4\) Life expectancy \= 12 weeks
•5\) Patients must have been at least one lesion, not previously irradiated, that can be measured accurately at baseline as \=10mm in the longest diameter (except lymph nodes which must have short axis \=15mm) with computerised tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeatede measurements
•6\) Radiological or clinical evidence of disease progression
•7\) Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing
•8\) Adequate haematologic and end organ function, defined by laboratory results obtained within 14 days prior to the first study treatment
•9\) Female patients of child\-bearing potential are eligible, provided they have a negative serum or urine pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception beginning 2 weeks before the first dose of investigational product and for 30 days after the final dose of investigational product. Male patients must agree to use appropriate contraception during the trial and for 3 months afterwards
•Criteria unique to the Dose Escalation Part (Phase 1b part):

•1\) Symptomatic CNS involvement or CNS involvement requiring steroid therapy; patients with treated brain metastases that are asymptomatic and have been clinically stable for 1 month will be eligible for protocol participation
•2\) Prior chemotherapy, biological therapy, radiation therapy, immunotherapy, other anticancer agents and any investigational agents within 14 days of starting study treatment
•3\) Any unresolved toxicity \> CTCAE Grade 1 from previous anti\-cancer therapy
•4\) Current refractory nausea and vomiting, chronic gastrointestinal disease or inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of the study medication
•5\) Significant cardiovascular disease
•6\) QTc prolongation defined as a QTc interval \>470msecs
•7\) Concomitant medications known to prolong QT interval
•8\) Patients receiving concomitant immunosuppressive agents or chronic systemic corticosteroids for \=28 days at the time of study entry
•9\)Evidence of interstitial fibrotic lung disease (bilateral, diffuse, parenchymal lung disease)
•10\) Clinically significant abnormalities of glucose metabolism