Dataset Information

Intervention study assessing the novel use of seviteronel in androgen receptor positive cancers

ABSTRACT: Interventions: Use of SEVI-D (Serivteronel and dexamethasone) in the treatment of androgen receptor positive solid tumours. Serivteronel will be administered orally at 450 mg (3 tables) once daily. It will be given in combination with one oral tablet of 0.5 mg tablet of Dexamethosone. SEVI-D will be continuously administered daily while on the study. Clinical and safety assessments are scheduled every 4 weeks during the study and then every 8 weeks after the end of the safety follow up period of the study. There is no set duration of administration and treatment will continue until the Clinical and/or disease assessments show no therapeutic benefit. The hospital pharmacy will keep a drug accountability record and patients will be asked to return any unused medication and empty drug containers. Primary outcome(s): To test the clinical activity of novel targeted treatments and/or indications as measured by objective tumour response or the ratio of time-to-progression on study over the preceding period using medical imaging tools (CT, MRI, PET or 18F-FDG PET).[Assessments will occur at pre-treatment and then routine imaging will occur every 8 weeks until disease progression. Radiological images will be assessed at each time point using either RECIST 1..1 or RANO criteria for disease progression] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy

DISEASE(S): Cancer-bladder,Cancer-bowel-anal,Cancer-sarcoma (also See 'bone')-soft Tissue,Cancer-kidney,Cancer-cervical (cervix),Cancer-malignant Melanoma,Cancer-other Cancer Types,Cancer-head And Neck,Cancer-liver,Cancer-lung-non Small Cell,Solid Cancers

PROVIDER: 2467471 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:The feasibility of longitudinal metastatic biopsies for gene expression profiling in breast cancer is unexplored. Dynamic changes in gene expression can potentially predict efficacy of targeted cancer drugs. Patients enrolled in a phase III trial of metastatic breast cancer with sunitinib combined with docetaxel (SU+DOC) versus docetaxel alone (DOC) were offered to participate in a translational substudy comprising longitudinal fine needle aspiration biopsies (FNAB) and positron emission imaging before (T1) and two weeks after start of treatment (T2). Aspirated tumor material was used for microarray analysis, and treatment-induced changes (T2 versus T1) in gene expression and standardized uptake values were investigated. Twenty-one patients were included in the docetaxel ± sunitinib trial at Karolinska and 18 of them agreed to participate in the substudy. Of the 18 women enrolled, 8 were randomly assigned to SU+DOC and 10 to DOC. Metastatic FNAB were carried out in 17 of the 18 patients at both time points with no complications reported. Representative tumor material, sufficient for RNA extraction was obtained in 15 patients at T1 and 14 patients at T2. Matched samples both at T1 and T2 were obtained for 14 subjects, 7 in each arm. The main objective was to determine whether gene expression profiling is feasible using sequential, intra-patient FNAB. Secondary objectives were to identify potential biomarkers of early response by gene expression and/or functional imaging and to explore drug action in vivo by changes in gene expression. A Karolinska substudy of the docetaxel ± sunitinib phase III clinical trial utilising sequential metastatic fine needle aspiration biopsies (FNAB) and 18-F-2-fluoro-2-deoxyglucose positron emission tomography/computed tomography (FDG PET/CT). In brief, the randomized docetaxel ± sunitinib trial compared sunitinib combined with docetaxel (SU+DOC) versus docetaxel alone (DOC), as first line therapy in patients with HER2 negative metastatic breast cancer. Patients in the exploratory substudy were subjected to baseline FDG PET/CT assessment, followed by FNAB of one tumor lesion prior to start of treatment (Time point T1). FDG PET/CT and FNAB were repeated at Day 14 ± 1 (Time point T2) when sunitinib has achieved steady state.

Project description:Interventions: This is a prospective multi-centre biomarker study involving the collection of plasma from patients with a Ras wild-type (according to the local standard of care) tumour planned for treatment with first-line cetuximab in combination with Irinotecan with fluorouracil (5FU) and folinic acid (FOLFIRI) or Oxaliplatin with fluorouracil (5FU) and folinic acid (FOLFOX) will be periodically assessed with the following minimum study procedures. Additional non-study assessments may occur at the discretion of the treating clinician. Blood sampling at the following time points: a) Baseline (within 7 days of starting anti-EGFR treatment) b) Week 3 of anti-EGFR treatment (after 2 weeks of treatment) c) Week 5 of anti-EGFR treatment (after 4 weeks of treatment) d) Every 4 weeks thereafter until disease progression Representative archival tumour sample (either primary or metastasis tissue) will be made available for next-generation sequencing (NGS) based Ras testing (unless already performed) and/or for repeat RAS mutation analysis by BEAMing (Beads, Emulsions, Amplification, and Magnetics) digital PCR (polymerase chain reaction) assay where there is any discordance between tumour tissue and cfDNA analysis. Images from the following staging CT chest/abdomen/pelvis performed as part of routine care will be centrally reviewed by a radiologist: a. Screening – within 4 weeks of starting anti-EGFR therapy b. Every 8 weeks until disease progression using CEA and imaging. Follow-up as per standard practice until disease progression, death or a maximum of 3 years, which ever occurs first. Primary outcome(s): To explore the emergence of Ras mutations in cfDNA as an escape mechanism for first-line cetuximab anti-EGFR therapy. To examine the emergence of Ras mutations during anti-EGFR therapy therapy, serial blood samples (30mls) will be collected and processed into plasma. The plasma will then be tested for Ras mutant status using BEAMing.[Patients will be examined for the period of time from therapy initiation to time when Ras mutations are first detected and followed by similar testing till disease progression. In addition, the levels (quantities) of Ras mutations detected in circulating tumour DNA (ctDNA) in plasma will be examined and compared over time. This will occur at baseline, week 3, week 5 and every 4 weeks thereafter while patients remain on anti-EGFR treatment or until disease progression. Patients recruited will be followed to documented disease progression; a mean time of follow up is estimated to be 11.4 months (estimated time from initiation of first-line cetuximab therapy to mean time progression free survival). Please note that cfDNA and ctDNA are used interchangeably. ] Study Design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective

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Intervention study assessing the novel use of seviteronel in androgen receptor positive cancers

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