Hyperalgesia

Pain, Postoperative

Andrea Fanelli

DNA Methylation and Perioperative Pain Treatment

Explorative Study About the Degree of DNA Methylation Related to Acute Perioperative Pain Treatment

University of Bologna

Two tbl. in the morning and two tbl. in teh evening until PD

Uveal Melanoma

two tablets in the morning and two in the evening.

Placebo

400 mg Sorafenib bid until PD if staging after Run-In was PR or CR

Sorafenib

400 mg Sorafenib bid until PD if staging after Run-In was SD

Universitätsmedizin Berlin, Charité Campus Benjamin Franklin

Universitätsklinikum Erlangen

Univesitätsklinikum Essen

A Study of Sorafenib in Patients With Chemonaive Metastatic Uveal Melanoma

A Randomized Discontinuation, Blinded, Placebo-Controlled Phase II Study of Sorafenib in Patients With Chemonaive Metastatic Uveal Melanoma

Prof. Dr. med. Max. E. Scheulen

Prof,. Dr. med.

ClinAssess GmbH

Non Small Cell Lung Cancer

The design of the first phase is a 3 +3 phase I trial. The Belinostat dose will start at 500 mg and will be increased with 250 mg until a maximum dose of 1500 mg, administered daily in 2/3 weeks. Each patient will at the same time receive 150 mg of Erlotinib daily continously.
When the patient is enrolled at one dose level, there will be no further dose escalation for that individual patient.
3 patients will be treated at each dose level.

Belinostat and Erlotinib

Dept of Oncology Copenhagen University Hospital Herlev

A Trial of Belinostat in Combination With Erlotinib in Patients With Non-small Cell Lung Cancer

A Clinical Phase I / II Trial of Belinostat in Combination With Erlotinib in Patients With Non-small Cell Lung Cancer

The primary purpose of the phase I part of the trial is to establish the tolerance dose (maximum tolerated dose (MTD) and dose limiting toxicity (DLT).

The phase II part of the study is to assess the efficacy of Belinostat and Erlotinib in combination assessed by disease control rate, defined as non - progression at 3 months / Stable disease or better) using RECIST response criteria version 1.1

MD Jon Lykkegaard Andersen

Herlev Hospital

Copenhagen University Hospital at Herlev

Bispebjerg Hospital

Onxeo

Roche Pharma AG

Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide
Starting doses Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m^2 orally once daily on Days 1-7 and 15-21.

This Phase I arm to be activated only after completion of Part A of the Phase II trial of the 3-Drug combination. If part A of the Phase II trial shows lack of efficacy, trial will be terminated.
Vorinostat orally twice daily, Days 1-14; and Erlotinib orally once daily Days 1-21 of every cycle.

Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study.
Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m^2 orally once daily on Days 1-7 and 15-21.

This Phase II Part B arm to be activated only after completion of Part A of the Phase I and II Part A trial of the 3-Drug combination. If part A of the Phase II trial shows lack of efficacy, trial will be terminated.
Vorinostat orally twice daily, Days 1-14; and Erlotinib orally once daily Days 1-21 of every cycle.

Brain Cancer

Glioblastoma Multiforme

Phase I Starting Dose: 200 mg twice daily by mouth on Days 1-7, 15-21 of each 28 day cycle.
Phase II Dose: MTD from Phase I.

Vorinostat

Phase I Starting Dose: 200 mg by mouth daily on Days 1-21 of 28 day cycle. For patients on enzyme inducing anticonvulsants (EIACs), starting dose of 400 mg.
Phase II Dose: MTD from Phase I.

Erlotinib

125 mg/m2 by mouth daily on days 1-7, 15-21 of each 28 day cycle.

Temozolomide

University of Texas MD Anderson Cancer Center Website

University of Texas MD Anderson Cancer Center

Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM)

Phase I / II Adaptive Randomized Trial of Vorinostat, Erlotinib and Temozolomide in Adults With Recurrent Glioblastoma Multiforme

Phase I assessment MTD Vorinostat in combination with escalating doses of Erlotinib and Temozolomide using conventional phase I design where 3 enrolled into first dose level, monitored for 3 weeks and if no dose-limiting toxicity (DLT) seen, 3 more enrolled at next dosage level. If 2/6 participants experience DLT, the previous (lower) dosage level declared MTD of vorinostat in combination with Erlotinib and Temozolomide.
A maximum of 4 dosage levels utilized with deescalation by 2 dose levels if DLT is seen at the starting dose level. If no DLT noted after dose escalation to Level 4, these doses utilized as MTD for phase II.

This is an adaptive randomized phase II trial to Vorinostat + Erlotinib to Vorinostat + Erlotinib + Temozolomide in patients with recurrent GBM. The primary outcome is progression free survival (PFS). Patients will be randomized between the two arms using a Bayesian adaptive algorithm. Participants randomized equally between the two arms at the start of the trial (for the first 20 patients). Thereafter, as the trial progresses and data accrue, the randomization will become unbalanced in favor of the treatment that, on average, has better results in terms of failure time. Therefore, each successive patient is more likely to receive the treatment with better results, on average. A minimum of 20 and a maximum of 90 patients will be accrued and there will be 6 months follow up after the last patient is accrued. Based on an anticipated accrual rate between 3 and 5 patients per month, the maximum trial accrual period will be between 30 and 18 months.

histone/kusma

DNA Methylation and Perioperative Pain Treatment

A Study of Sorafenib in Patients With Chemonaive Metastatic Uveal Melanoma

A Trial of Belinostat in Combination With Erlotinib in Patients With Non-small Cell Lung Cancer

Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM)

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