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A phase 1, randomized, double blind, placebo-controlled, single ascending dose study to assess safety, tolerability and pharmacokinetics of cRGD-ZW800-1 intravenous injection in healthy volunteers

Primary objective- To determine safety and tolerability of a single dose of cRGD-ZW800-1 in healthy volunteers.Secondary objectives- To determine the pharmacokinetics of a single dose of cRGD-ZW800-1 by measuring the fluorescence of blood and urine…

A Randomized, Placebo-Controlled Crossover Study to Evaluate the Effect of Veliparib (ABT-888) on Cardiac Repolarization in Subjects with Relapsed or Refractory Solid Tumors

The objective of this study is to evaluate the effect of veliparib on QTcF.

A phase 1, placebo-controlled, single ascending-dose study to assess the safety, tolerability and pharmacokinetics of OTL-038 injection in healthy volunteers

Primary objective:To assess the safety, tolerability and pharmacokinetics of a single IV dosages of OTL-038. Selected doses of OTL-038 will be studied in the absence and presence of prophylactic treatment with the antihistamine clemastine to be…

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 Randomized Discontinuation Study of Brivanib alaninate (BMS-582664) versus Placebo in Subjects with Advanced Tumors.

Compare Progression Free Survival (PFS) for brivanib versus placebo in subjects with advanced solid tumors with FGF-2 over-expression and who have obtained stable disease after 12 weeks of treatment with brivanib separately for each tumor.

A PHASE 1, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL IN HEALTHY VOLUNTEERS TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING SINGLE AND MULTIPLE DOSES OF SNDX-6352 OR PLACEBO ADMINISTERED BY INTRAVENOUS (I.V.) INFUSION

The purpose of the study is to investigate to what extent SNDX-6352 is tolerated.It will also be investigated how quickly and to what extent SNDX-6352 is absorbed and eliminated from the body (pharmacokinetics). In addition, also the…

A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor (INTERLINK-1)

The study will compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) by assessment of Overall Survival in HPV-unrelated participants. The formal statistical analysis will be performed to test the following…

A Randomized Phase III study of pembrolizumab given concomitantly with chemoradiation and as maintenance therapy versus chemoradiation alone in subjects with locally advanced head and neck squamous cell carcinoma (KEYNOTE-412)

Primary: To compare Event-free survival (EFS) per RECIST in subjects treated with pembrolizumab in combination with CRT and subjects treated with placebo in combination with CRT.Secondary:(1) To compare Overall Survival (OS) in subjects treated with…

A blind randomized multicenter study of accelerated fractionated chemo-radiotherapy with or without the hypoxic radiosensitizer nimorazole (Nimoral), using a 15 gene signature for hypoxia in the treatment of squamous cell carcinoma of the head and neck.

There are two primary objectives in this study: The first of them is to evaluate in a blinded randomized trial, whether the hypoxic cell radiosensitizer nimorazole can improve the effect of primary curative accelerated fractionated concomitant chemo…

A phase 1, randomized, double blind, placebo-controlled, single and repeated ascending dose study to assess safety, tolerability and pharmacokinetics of ZW800-1 injected intravenously into healthy volunteers

Primary Objective- To determine safety and tolerability of a single dose of ZW800-1 in healthy volunteers.Secondary Objectives- To determine the pharmacokinetics of a single dose of ZW800-1 by measuring the fluorescence of blood and urine.- To…