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NCT ID: NCT02134197 Terminated - Neoplasms Clinical Trials

Dose-escalation Study of Lupartumab Amadotin (BAY1129980)

Start date: May 22, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate: - The side effects of BAY1129980 when given every 21 days different dose levels. - Determine the dose level of BAY1129980 that should be tested in future clinical research studies. - Measure how much BAY1129980 is in the blood at specific times after administration. - If treatment with BAY1129980 shows any effect on reducing the tumor growth. - If there are specific biomarkers that might be able to explain why some patients respond to treatment and others do not. - If treatment with BAY1129980 causes an immune response from the body against the drug (immunogenicity).

NCT ID: NCT02134067 Terminated - Clinical trials for Advanced Solid Tumors

Dose-escalating, Safety, Tolerability and PK Study of TAS-119 in Combination With Paclitaxel in Patients With Advanced Solid Tumors

Start date: August 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety of TAS-119 and determine the most appropriate dose in combination with Paclitaxel for subsequent studies in patients with advanced solid tumors. TAS-119 is a novel, selective Aurora A kinase inhibitor, which has previously been demonstrated to enhance the activity of paclitaxel in preclinical studies

NCT ID: NCT02133274 Terminated - Neoplasms Clinical Trials

A Psychosocial Intervention Plus Early Palliative Care in the Reduction of Depression of Advanced Cancer Patients

PREPArE
Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a brief psychosocial intervention together with early palliative care are feasible, acceptable and effective in the reduction of depressive symptoms of patients with advanced cancers starting first line palliative chemotherapy.

NCT ID: NCT02131506 Terminated - Clinical trials for Malignant Neoplasm of Breast

A Study of Lapatinib in Combination With Caelyx in Patients With Advanced HER2 Positive Pretreated Breast Cancer

CAELYX
Start date: December 2009
Phase: Phase 1
Study type: Interventional

A Phase Ib Study of Lapatinib in Combination with Caelyx in Patients with Advanced HER2 positive pretreated Breast Cancer. Treatment Plan: Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq & Lapatinib 1000 mg die; dose level 1, Caelyx 30 mg/mq & Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq & Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq & Lapatinib 1500 mg die. Three patients will be initially enrolled in each dose level starting from level 1. If none of the first triplet of patients will develop DLT, the dose will be escalated to the next level for the subsequent three patients. If one of the first triplets of patients will develop first-course DLT, a maximum of 3 additional patients will be entered at the same dose level. The MTD is defined as the dose below that at which two patients have experienced DLT. Lapatinib will be self-administered by the patient in an outpatient setting at the dose of the assigned step. Patients will take the drug daily by mouth on days 1 to 21 of each cycle. Caelyx will be administered by intravenous infusion over an exact period of 1 hour (preferably by a pump to guarantee a constant speed of infusion) on day 1 of each cycle repeated every 21 days. STATISTICAL METHODOLOGY: Evaluation of toxicity: all patients will be evaluable for toxicity from the time of their first treatment with Caelyx and Lapatinib. Evaluation of response: all patients included in the study must be assessed for response to treatment, even if there are major protocol treatment deviations or if they are ineligible. All conclusions should be based on all eligible patients. Subanalyses may then be performed on the basis of a subset of patients, excluding those for whom major protocol deviations have been identified .However, these subanalyses may not serve as the basis for drawing conclusions concerning treatment efficacy, and the reasons for excluding patients from the analysis should be clearly reported. The 95% confidence intervals should also be provided.

NCT ID: NCT02129335 Terminated - Neoplasms Clinical Trials

Stress, Exercise Behavior and Survival in Patients With Newly Diagnosed Glioblastoma and in a Close Partner

TOGETHER
Start date: April 2014
Phase: N/A
Study type: Observational

Glioblastoma multiforme (GBM) is the most common malignant central nervous system (CNS) tumor in adulthood with a median survival of 12-16 months. The drastically shorted life expectancy, intellectual changes and rapid physical decline in those patients are devastating and do impose a profound chronic stress on patients and their families. There is extensive evidence that chronic stress can promote cancer growth and progression. In the setting of GBM patients, three major questions still have to be answered and will be analysed in this study: 1. Is there a prognostic significance of stress in patients with newly diagnosed GBM on treatment tolerance and (progression free) survival? 2. Can this stress be modulated by other factors, like stress of patients partners and patients physical activity, a known independent prognostic factor in recurrent glioma patients? 3. How is the longitudinal course of patients and partners stress and physical condition over the disease course and do they influence (progression free) survival? Answers to these questions will help to establish future projects studying non drug interventions in patients and patients partners to help improving clinical and tumor related outcome in patients with newly diagnosed GBM. The investigators hypothesize that chronic stress, specifically measured as a disruption of the diurnal cortisol rhythmicity, is an independent prognostic factor in patients with GBM. Furthermore, physical activity of patients and stress level in patients` partners may impact - as stress-modulating factors- on stress in patients and on their prognosis. Aiming at identifying stress-related prognostic factors as potential targets for novel treatment approaches, we propose, in a first step, a prospective multicenter cohort study: all patients with newly diagnosed GBM and good performance status (KPS ≥ 50%) who undergo standard treatment with combined radiochemotherapy with temozolomide (RCT) followed by 6 month of cyclic temozolomide, are eligible. In addition, one "partner", defined as a close person living in the same home or close daily contact to the patient, will be asked for inclusion.

NCT ID: NCT02129205 Terminated - Breast Cancer Clinical Trials

A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors

Start date: June 2014
Phase: Phase 1
Study type: Interventional

To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

NCT ID: NCT02122146 Terminated - Neoplasms Clinical Trials

A Study Of PF-06664178 In Patients With Advanced Solid Tumors

Start date: August 2014
Phase: Phase 1
Study type: Interventional

To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

NCT ID: NCT02114827 Terminated - Malignant Neoplasm Clinical Trials

Efficacy of a Patient Education Video

Start date: April 2014
Phase: N/A
Study type: Interventional

Patients in the intervention arm will view the 23-minute video depicting the Hematopoietic stem cell transplantation (HSCT) experience. Patients in the control arm will receive HSCT frequently asked questions (FAQ) sheet developed by the National Cancer Institute (NCI) at the National Institutes of Health (NIH).

NCT ID: NCT02111824 Terminated - Neoplasms Clinical Trials

A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy

MIMIG
Start date: January 5, 2014
Phase: Phase 1
Study type: Interventional

The goal of this clinical research study is to test the use of a minimally invasive multimodality image-guided (MIMIG) intervention system used for performing a lung biopsy. The safety of the MIMIG intervention system will also be studied.

NCT ID: NCT02110563 Terminated - Multiple Myeloma Clinical Trials

Phase I, Multicenter, Dose Escalation Study of DCR-MYC in Patients With Solid Tumors, Multiple Myeloma, or Lymphoma

Start date: April 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of the investigational anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid particle suspension that targets the oncogene MYC. MYC oncogene activation is important to the growth of many hematologic and solid tumor malignancies. In this study the Sponsor proposes to study DCR-MYC and its ability to inhibit MYC and thereby inhibit cancer cell growth.