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NCT ID: NCT01827644 Completed - Cancer Clinical Trials

Bioavailability and Food Effect of the Original Gelatin Formulation and Two New Formulations of Afuresertib in Normal Healthy Volunteers

Start date: April 24, 2013
Phase: Phase 1
Study type: Interventional

This will be a randomized, open-label, sequential, single dose, 4-period crossover study. This study is being conducted to measure the relative bioavailability of the original gelatin capsule (GC) formulation and two new formulations (hydroxypropyl-methylcellulose [HPMC] capsule and enteric coated tablet [ECT]) of afuresertib (AFU), in the fed and fasted state. The study will be composed of Screening, Treatment, and Follow-up Periods. Screening assessments to determine subject eligibility will be performed within 3 weeks prior to the first dose of study drug in the Treatment Period. Eligible subjects will be randomized to receive 4 of the 6 possible study treatments (A: AFU GC administered in a fasted state, B: AFU GC administered in a fed state, C: AFU HPMC capsule administered in a fasted state, D: AFU HPMC capsule administered in a fed state, E: AFU ECT administered in a fasted state, F: AFU ECT administered in a fed state) in 4 treatment periods (one per treatment period). Subjects will receive a single dose of one of the six study treatments (A, B, C, D, E, F) on Day 1 of each Dosing Period, according to one of the 6 treatment sequences (CEDA, EFAB, ABFC, BDCE, FCBD, DAEF). There will be a minimum of 10 Day washout period between the doses administered in each Treatment Period. A Follow-up visit will be conducted within 10-14 days after the last dose. A subject's total time involved in the study will be approximately 9 weeks. At least 36 subjects will be enrolled in the study, to ensure that at least 6 subjects will be randomized to receive each treatment sequence.

NCT ID: NCT01827514 Active, not recruiting - Cancer Clinical Trials

Studying Erythropoietin Receptor Presence and Function in Human Cancer Specimens

EPO-CAN
Start date: January 2013
Phase: N/A
Study type: Observational

Erythropoietin, EPO, is the main regulator and stimulator of bone marrow erythropoiesis, and is responsible for growth and differentiation of the erythroid cell lineage. Our team, in collaboration with partners (see below) has taken responsibility to study the presence, function and clinical significance of EPO-R in human cancer specimens. General Aim of the Proposed Project: To study EPO-R in human cancer specimens. Prepared slides from already taken preparations (specimens from Bone Marrow tests) will serve as the basis for that part of the work.Specimens will be taken from Breast cancer, Colon cancer, Lung cancer, Head & Neck cancer and from Lymph nodes biopsy (positive for lymphoma) The slides will be stained with anti-EPO-R antibodies (Abs).

NCT ID: NCT01821456 Recruiting - Cancer Clinical Trials

Cologne Cohort of Neutropenic Patients (CoCoNut)

CoCoNut
Start date: January 1995
Phase: N/A
Study type: Observational

The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study assessing risk factors, interventions, and outcome of immunosuppressed patients with or without opportunistic infections.

NCT ID: NCT01819649 Completed - Cancer Clinical Trials

Selenium in the Prevention of Cancer

DK PRECISE
Start date: November 1998
Phase: N/A
Study type: Interventional

This is a pilot study proceeding an intended international trial. Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast tablets will reduce the risk of cancer in healthy individuals. Objective: The objective of this pilot study was to assess the viability of a full scale randomised trial. AMENDMENT TO STUDY OBJECTIVE: Mortality analysis during intervention and follow-up as specified in the sections concerning study design and outcome measures.

NCT ID: NCT01817257 Terminated - Cancer Clinical Trials

Anticoagulation Length in Cancer Associated Thrombosis

ALICAT
Start date: December 2013
Phase: Phase 2
Study type: Interventional

This is a two year, multicentre, mixed methods feasibility study including a randomised controlled two-arm interventional trial, a nested qualitative study, focus groups and a United Kingdom (UK) wide survey exercise.

NCT ID: NCT01813474 Completed - Cancer Clinical Trials

Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies

Start date: March 25, 2013
Phase: Phase 1
Study type: Interventional

The objective of this study will be to investigate the safety and tolerability of olaparib tablet when given orally to Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.

NCT ID: NCT01812616 Completed - Cancer Clinical Trials

A Safety Study of Sativex Compared With Placebo (Both With Dose-intense Temozolomide) in Recurrent Glioblastoma Patients

Start date: September 2014
Phase: Phase 1/Phase 2
Study type: Interventional

An open-label phase to assess the frequency and severity of adverse events in recurrent glioblastoma patients receiving Sativex in combination with dose-intense Temozolomide (Part A). A randomisation phase to assess the safety of Sativex compared with placebo (Part B). Part B will be reported here.

NCT ID: NCT01812603 Completed - Cancer Clinical Trials

A Safety Study of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma

Start date: September 2013
Phase: Phase 1/Phase 2
Study type: Interventional

An open-label phase to assess the frequency and severity of adverse events in recurrent glioblastoma patients receiving Sativex in combination with dose-intense Temozolomide (Part A). A randomisation phase to assess the safety of Sativex compared with placebo (Part B). Part A will be reported here.

NCT ID: NCT01809730 Withdrawn - Hypertension Clinical Trials

Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

Start date: May 2012
Phase: N/A
Study type: Observational

This is a non-randomized, non-interventional pilot observational study designed to follow high-risk patients through their surgical and hospital stay. The investigators will collect 2 4ml vial's of blood (total of 8ml) prior to surgery to assess CV biomarkers - inflammatory, metabolic, hypercoagulable and platelet.

NCT ID: NCT01809405 Unknown status - Cancer Clinical Trials

Validation of Sexual Function Scale in Female Cancer

Start date: December 2012
Phase: N/A
Study type: Observational [Patient Registry]

To validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual Function(QSF) version in Korean language of the cancer patients.