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A phase Ib/II, multicenter, open label, study of LEE011 in combination with MEK162 in adult patients with NRAS mutant melanoma

Primary objective: Phase Ib (see study design): Maximum Tolerated Dose(s) and/or Recommended Phase II Dose (RP2D) of LEE011 and MEK162 in combination. Phase II (see study design): Assess the anti-tumor activity of the LEE011 and MEK162 combination…

A Phase 1 Study of ABT-767 in BRCA1- or BRCA2-Mutation Carriers with Advanced Solid Tumors and in Subjects with High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The primary objective of this study is to assess the safety, tolerability, and pharmacokinetics of ABT-767 and the effect of food on ABT-767 bioavailability in subjects with BRCA1 or BRCA2 germ line mutation and associated solid tumors (e.g. breast…

A Phase I open-label dose escalation study with expansion to assess the safety and tolerability of INC280 in patients with c-MET dependent advanced solid tumors

Primary objective: To determine the MTD/highest studied dose determined to be safe, the safety and tolerability of INC280 as a single agent when administered orally to adult patients with c-MET dependent advanced solid malignancies.Secondary…

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 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

A phase Ib/II, multi-center, open-label study to evaluate the efficacy of AUY922 in combination with Trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer, that has progressed after or during at least one Trastuzumab-containing regimen.

Primary objective(s)Phase Ib:-Define the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD) of AUY922 in combination with Trastuzumab in patients with advanced or metastatic HER2-positive breast cancers.Phase II:-Evaluate…

An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis

This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability…

An open label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with psoriatic arthritis

This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability…

A phase 1 multicenter, open label, dose-escalation study of oral LEE011 in patients with advanced solid tumors or lymphomas.

Primary To determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLT) of LEE011 when administered orally once daily for 21 consecutive days followed by a 7 day break.Secondary *Safety and tolerability of LEE011.*…

A phase IA, multicenter, open-label dose escalation study of oral BYL719, in adult patients with advanced solid malignancies, whose tumors have a alteration of the PIK3CA gene.

Primary* To determine the maximum tolerated dose or recommended phase 2 dose of oral BYL719 as single agent and in combination with fulvestrantSecondary* To assess the overall safety and tolerability of BYL719 as single agent and in combination with…

A MULTI-CENTER, RANDOMIZED, CROSS-OVER, DOUBLE-BLIND, THIRD PARTY OPEN, PLACEBO CONTROLLED, PILOT STUDY TO ASSESS THE URODYNAMIC EFFECTS OF MODIFIED RELEASE UK-369,003 IN MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS)

A pilot study to:1. assess the urodynamic changes induced by 100mg MR formulationof UK-369,003 vs. placebo in men with LUTS;2. Assess the safety and tolerability of UK-369,003 in men with LUTS

A phase II, multicentre study of oral LBH589 in patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors

Primary1. To assess the major (complete/partial) cytogenetic response (MCyR) rateSecondary1. To determine the duration of MCyR2. To determine the complete hematologic response (CHR) rate3. To determine the complete cytogenetic response (CCyR) rate4…

A phase Ib, open-label, two arm study of i.v. and oral panobinostat (LBH589) in combination with i.v. trastuzumab (Herceptin®) and i.v. paclitaxel as treatment for adult female patients with HER2 overexpressing metastatic breast cancer (MBC)

The purpose of this phase Ib study is to determine the maximum tolerated dose (MTD) of i.v. and oral panobinostat when given in combination with trastuzumab and paclitaxel. Additional patients will be enrolled at the MTD to further evaluate the…

A Multi-center, Parallel-group, Double-blind, Placebo-controlled, Randomized, Ascending Dose Trial to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Infusions of OPC-108459 Administered to Subjects with Paroxysmal and Persistent Atrial Fibrillation.

Objective(s): Part 1: To determine the safety, tolerability, pharmacokinetics (PK), and efficacy of single ascending doses of OPC-108459 following one 10-minute constant rate infusion in adultsubjects diagnosed with paroxysmal or persistent AF. Part…

A Phase 2, Randomized, Double-Blind, Placebo Controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis

Primary objective:To evaluate the effect of each of 2 doses of AK001 separately in combination with an INS versus the INS alone on the reduction in size of nasal polyps as evaluated by the change from Baseline to Week 12 after the start of treatment…

Near-infrared fluorescence imaging in kidney transplantations using ZW800-1 for perfusion assessment: a pilot study

To assess the feasibility of ZW800-1 in the intraoperative assessment of kidney and ureter perfusion during kidney transplantations (living donor nephrectomy and transplantation)

A phase Ib/II multi-center, open-label, dose escalation study of LGX818 and cetuximab or LGX818, BYL719, and cetuximab in patients with BRAF mutant metastatic colorectal cancer.

Primary objectives Phase Ib: To estimate the MTD and/or RP2D of LGX818 in combination with cetuximab ± BYL719. Incidence of dose-limiting toxicities (DLTs). Phase II: To compare the efficacy of the dual (LGX818, cetuximab) and triple (LGX818, BYL719…

Phase I/II study with the combination of dacomitinib and PD-0325901 in metastatic KRAS mutation positive non-small cell lung cancer

Primary objectivesPhase I:To determine the recommended phase 2 dose (RP2D) of the dacomitinib-PD-0325901 combination in patients with KRASm NSCLC Phase II:To determine the progression free survival of the dacomitinib/PD-0325901 combination compared…

A Phase Ib, open label, multicenter study of the safety and efficacy of MIW815 (ADU-S100) administered by intratumoral injection with PDR001 to patients with advanced/metastatic solid tumors or lymphomas

Primary: To characterize safety and tolerability of MIW815 (ADU-S100) given with PDR001 and identify recommended doses and schedule for future studies.Secondary: Anti-tumor activity. Pharmacodynamics (PD). Pharmacokinetics (PK).

A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 plus Tilsotolimod and Other Therapy Combinations in Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

To assess safety, tolerability, and PK of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and Budigalimab in subjects with R/M HNSCC.