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Neoplasms clinical trials

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NCT ID: NCT02644460 Completed - Clinical trials for Diffuse Intrinsic Pontine Glioma

Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors

AflacST1501
Start date: February 2016
Phase: Phase 1
Study type: Interventional

This is a Phase I clinical trial evaluating abemaciclib (LY2835219), an inhibitor of cyclin dependent-kinases 4 and 6 (Cdk 4/6) in children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum A) and in relapsed/refractory/progressive malignant brain (Grade III/IV, including DIPG; MBT) and solid tumor (ST) patients (Stratum B).

NCT ID: NCT02644291 Completed - Glioblastoma Clinical Trials

Phase I Study of Mebendazole Therapy for Recurrent/Progressive Pediatric Brain Tumors

Start date: May 2016
Phase: Phase 1
Study type: Interventional

This is a safety (Phase 1) trial using mebendazole for recurrent pediatric brain cancers that include medulloblastoma and high grade glioma, that are no longing responding to standard therapies. The drug mebendazole is an oral drug in a chewable 500 mg orange flavored tablet. It is already approved to treat parasitic infections. The purpose of this study is to determine the safety and side effects for increasing doses of mebendazole, followed by the treatment of an additional 12 patients at the best tolerated dose.

NCT ID: NCT02641938 Completed - Malignant Tumor Clinical Trials

Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury

Start date: December 2015
Phase: Phase 4
Study type: Interventional

To investigate the renal protective effect of dexmedetomidine in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy

NCT ID: NCT02641691 Completed - Rectal Cancer Clinical Trials

Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum

NORMAL-R
Start date: May 27, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to look at how tumors responds to a short course of radiation (5 days) followed by 8 cycles of chemotherapy.

NCT ID: NCT02640755 Completed - Solid Malignancies Clinical Trials

Absorption, Metabolism, Excretion and Pharmacokinetics of a Single Dose [14C]AZD2014 Followed by a Multiple Dose Phase

14C
Start date: January 28, 2016
Phase: Phase 1
Study type: Interventional

This Phase 1, open label, single centre, non-randomised study in patients with advanced solid malignancies consists of two parts: 1. Single Dose Period - will characterise the absorption, metabolism, excretion and pharmacokinetics of a single oral dose of [14C]AZD2014 from the body 2. Multiple Dose Period - will further assess the safety and tolerability and anti-tumour activity of multiple doses of AZD2014 when given as a monotherapy or given in combination with paclitaxel or fulvestrant.

NCT ID: NCT02640508 Completed - Cancer Clinical Trials

Eribulin and Lenvatinib in Advanced Solid Tumors

Start date: May 2016
Phase: Phase 2
Study type: Interventional

The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.

NCT ID: NCT02640365 Completed - Clinical trials for Unresectable Advanced Cancer

A Dose Escalation Study of MM-398 Plus Irinotecan in Patients With Unresectable Advanced Cancer

DOUBLIRI
Start date: November 18, 2015
Phase: Phase 1
Study type: Interventional

MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan: the liposomal formulation is designed to extend plasma circulation and to increase accumulation in the tumor through the enhanced permeability and retention (EPR) effect. This study introduces a new concept of combining free and nanoliposomal drugs.

NCT ID: NCT02639546 Completed - Solid Tumors Clinical Trials

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors

iMATRIXcobi
Start date: May 20, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.

NCT ID: NCT02636426 Completed - Neoplasms Clinical Trials

Sorafenib Administered Using a High-dose, Pulsatile Regimen: a Phase I Exposure Escalation Study

SOPRANO
Start date: September 2015
Phase: Phase 1
Study type: Interventional

Sorafenib is an oral anticancer drug and inhibits multiple protein kinases important for tumor growth and metastases, including VEGFR, PDGFR, and RAF kinases. In daily clinical practice it is currently used at a dose of 400 mg twice daily in a continuous schedule. In this phase I study patients will be treated with a new dosing schedule of sorafenib: i.e. a high-dose, pulsatile schedule. The tolerability and safety of this new schedule is examined in exposure escalation cohorts based on a target plasma AUC0-12h (area under the curve). Exposure escalation cohorts are used instead of conventional dose escalation cohorts because the effect of a drug is dependent of its AUC levels and large differences in plasma sorafenib AUC0-12h have previously been shown between patients treated at the same dose level. Using pharmacokinetic monitoring, the sorafenib dose will be adjusted to a target plasma AUC0-12h. The escalation cohorts consist of 3-6 patients per exposure level starting with a target plasma sorafenib AUC0-12h level of 25-50 mg/L/h. After the determination of the maximum tolerated AUC0-12h, 10 additional patients will be entered into an expansion cohort. In the expansion cohort the patients will be treated with a weekly pulse of sorafenib at the maximum tolerated AUC0-12h for further assessment of safety and preliminary exploration of efficacy.

NCT ID: NCT02632370 Completed - Malignant Gliomas Clinical Trials

5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor

Start date: May 2016
Phase:
Study type: Observational

In support of the US marketing application for 5-ALA, this single arm trial is being conducted to establish the efficacy and safety of Gliolan® (5-ALA) in patients with newly diagnosed or recurrent malignant gliomas. The hypothesis of the study is Gliolan® (5-ALA), as an adjunct to tumor resection, is safe and that real-time tissue fluorescence correlates with malignant histopathology. The primary objective in this single arm study is to define the positive predictive value (PPV) of Gliolan®-induced PPIX fluorescence for malignant tumor at the time of initial resection and first use of FGS by taking a biopsy of tissue presenting with red fluorescence when observed during the course of resection of new or recurrent malignant gliomas. The functionality and performance reliability of the blue light excitation microscope platforms will be assessed.