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An Open-Label, Non-randomised, Parallel Group, Multicentre, Phase I Study to Assess the Safety and the Effect of Olaparib at Steady State on the Pharmacokinetics of the Anti-hormonal Agents Anastrozole, Letrozole and Tamoxifen at Steady State, and the Effect of the Anti-hormonal Agents on Olaparib, Following Administration in Patients With Advanced Solid Cancer

• To evaluate the effect of olaparib on exposure to anastrozole by determination of steady-state exposure to anastrozole in the presence and absence of steady-state exposure to olaparib• To evaluate the effect of anastrozole on exposure to olaparib…

An open-label multi-center single agent panobinostat rollover protocol for patients who have completed a previous Novartis-sponsored panobinostat study and are judged by the investigator to benefit from continued single agent panobinostat treatment (CLBH589B2402B)

Primary: To allow continued use of panobinostat to patients receiving single agent therapy with panobinostat in a Novartis-sponsored study.Secondary: To collect long term data on SAEs.

Phase I pharmacological study of continuous and intermittent chronomodulated capecitabine therapy

To determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended dose (RD) of continuous and intermittent chronomodulated capecitabine.Secondary study objectives are:To determine plasma pharmacokinetics of capecitabine…

A phase Ib, open-label study of oral BGJ398 in combination with oral BYL719 in adult patients with select advanced solid tumors

The primary objective of the study is to determine the MTD (maximum tolerated dose) and/or RDE (recommended dose for expansion) of BGJ398 in combination with BYL719.The secondary objectives are to characterize the safety and tolerability of BGJ398…

A phase Ib-II study of the combination of cetuximab and methotrexate in recurrent or metastatic squamous cell carcinoma of the head and neck. A study of the Dutch Head and Neck Society.
DHNS 2013-01 / MOHN01

Primary objective:• Phase Ib: to assess the feasibility and safety of the addition of cetuximab to methotrexate for recurrent or metastatic SCCHN • Phase II: to assess the efficacy of the addition of cetuximab to methotrexate for recurrent or…

A PHASE 1 STUDY OF CC-486 AS A SINGLE AGENT AND IN COMBINATION WITH CARBOPLATIN OR ABI-007 IN SUBJECTS WITH RELAPSED OR REFRACTORY SOLID TUMORS

Primary objective:the primary objective of the study is to evaluate the safety and to define the maximal tolerated dose or the maximal administered dose of CC-486 as a single agent, in combination with CBDCA or ABI-007 in subjects with relapsed or…

A phase I, open-label, multi-center study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and varying degrees of renal function

As results from a recently completed radio-labeled human ADME study [CLBH589B2108] in patients indicated that both kidney and liver are involved in the elimination and metabolism of panobinostat, understanding the impact of altered organ function…

A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination with Cetuximab in Second-Line Cetuximab-Naive Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)

The primary objective of this trial is to determine if EMD 1201081 (formerly known as IMO-2055) has anti-tumor activity in subjects by examining its effects on accepted clinical endpoints in combination with cetuximab. • To evaluate progression-free…

A phase I, multicenter, open-label dose escalation study of LDK378, administered orally in adult patients with tumors characterized by genetic abnormalities in anaplastic lymphoma kinase(ALK)

Primary To determine the MTD of LDK378 (oral administration) as a single agent Secondary* Safety and tolerability of LDK378* To characterize single and multiple-dose PK of LDK378.* To assess preliminary anti-tumor activity of LDK378

Pilot study on the determination of intratumoral concentrations of kinase inhibitors in patients with advanced solid malignancies

The main objective of this pilot study is to determine intratumoral concentrations of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.

An open-label, dose escalating Phase Ib study for the assessment of safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple intravenous doses of GLPG0187 in subjects with solid tumors.

Primary objective:To assess the safety and tolerability of GLPG0187 when administered intravenously (IV) as a continuous infusion in subjects with solid tumors in order to determine the Recommended Phase II Dose (RP2D).Secondary objectives:• To…

Determination of dihydropyrimidine dehydrogenase and thymidylate synthase activity in human peripheral blood mononuclear cells in healthy volunteers.

Primary objective:• To determine the range and mean population DPD and TS enzyme activity in human peripheral blood mononuclear cells in 20 healthy volunteers. Secondary objectives:• To determine the circadian rhythm of DPD and TS enzyme activity in…

An Open-label, Dose Escalation, Pharmacodynamic, Pharmacokinetic, and Effect of Food Phase 1 Study of E7820, Administered as a Once Daily and Twice Daily Oral Dose to Determine the Maximum Tolerated Dose in Subjects with Unresectable Solid Tumors

Part A Food Effect StudyPrimary Objective• To determine the effect of a high fat meal on oral bioavailability of 50 mg E7820 in comparison with fasting conditions.Secondary Objectives• To determine the safety and tolerability of E7820.• To determine…

A Phase I, multi-center, open label, dose escalation study of LEQ506, an oral Smoothened inhibitor, in patients with advanced solid tumors

Primary objectiveTo determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLT) of LEQ506 when administered orally on a continuous daily dosing schedule.Secondary objectives* To characterize the safety and…

"Effects of Cimetidine on Cisplatin-induced Nephrotoxicity"

2.5 Study rationaleThe nephrotoxicity caused by cisplatin is of great concern both in that it is dose-limiting and can be detrimental to the patient. Much work has been done to reduce or prevent this damage to renal cells, however to date the best…

A Phase 1/2, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy and Pharmacokinetics of BMS-753493 in Subject with Advanced Cancer

To determine the maximum tolerated dose, dose limiting toxicity and recommended Phase 2 dose of BMS-753493 in subjects with advanced cancer.

A Phase II/III Study of MK-0646 Treatment in Combination with Cetuximab and
Irinotecan for Patients with Metastatic Colorectal Cancer

There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…

A phase I dose escalation study of intravesical TMX-101 in subjects with Non-Muscle-Invasive Bladder Cancer

The primary objectives are the following:- To assess the safety profile and determine the Optimal Biological Dose (OBD) or Maximum Tolerated Dose (MTD), whichever occurs first, of intravesically administered TMX-101. The secondary objectives are the…

A phase II study of cediranib as palliative treatment in patients with symptomatic malignant ascites or pleural effusion

Primary objective:To assess the puncture free survival after start of treatment with cediranib (time to first need for paracentesis or thoracentesis or time to death, which event occurred first)Secondary objectives:-To assess the palliative effects…

Mass balance of docetaxel after administration of Oral Docetaxel in combination with Ritonavir

The primary objective of this study is to quantitatively determine the pharmacokinetics (absorption, distribution, metabolism and excretion) of docetaxel (as ModraDoc003 10mg tablets) after administration of a single dose of oral docetaxel in…