Metastatic
E7080
An Open-Label, 2-Cohort, Multicenter, Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
Sponsor: Eisai Inc.
The purpose of this study is to assess the objective response rate of E7080 in previously treated subjects with American Joint Committee on Cancer (AJCC) unresectable stage III or stage IV melanoma and disease progression.
Status: Recruiting
Contact: Medhia Survery
BRF113220
An Open-Label, Dose-Escalation, Phase I Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the BRAF Inhibitor GSK2118436 in Combination With the MEK Inhibitor GSK1120212 in Subjects With BRAF Mutant Metastatic Melanoma
Sponsor: GlaxoSmithKlineThis is an open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK2118436 and GSK1120212 in combination. This study is designed in three parts. In Part A, the effect of repeat doses of GSK1120212 on the pharmacokinetics of single dose GSK2118436, will be investigated prior to evaluating combination regimens. In Part B, the range of tolerated dose-combinations will be identified using a dose-escalation procedure. In Part C, different dose combinations of GSK2118436 and GSK1120212 will be evaluated, based on results from the dose Eligability: Click hereStatus: Recruiting
Contact: Joanna Jackson / Rebecca Hinshelwood
MO25515An openlabel, multicentre expanded access study of RO5185426 in patients with metastatic melanomaSponsor: Hoffmann-La Roche This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options. Eligability: Click hereStatus: RecruitingContact: Medhia Survery
MK3475 PD-1MK-3475 Protocol 001 Part B & C: Phase I Study of Single Agent MK-3475 in Patients with Solid Tumors and MelanomaSponsor: Merck, Sharp & Dohme (Australia)
This study will be done in 3 parts. In Part A the dose of intravenous (IV) MK-3475 will be escalated to find the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for participants with a histologically or cytologically confirmed diagnosis of any type of carcinoma or melanoma (MEL). Part B of the study will explore the efficacy of the drug in participants with advanced or metastatic MEL. Part C of the study will explore the efficacy of the drug in participants with non-small cell lung carcinoma (NSCLC) that is locally advanced or metastatic. (Please note that this site is participating in PARTS B & C only)Eligability: Click hereStatus: RecruitingContact: Meenal Rai
MORAb 004-201 Melanoma
A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects With Metastatic Melanoma
Sponsor: Morphotek
This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma. 80+ subjects at 25 sites in the U.S., U.K., Germany and Australia will be randomized into one of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease progression. Subjects must have measurable disease by CT Scan or MRI and must have completed at least one prior round of chemotherapy. Subjects will be assessed for Efficacy, PK/PD, Overall survival, and Safety (Adverse Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical exams/vital signs, tolerability). Eligability: Click hereStatus: RecruitingContact: Raymond Tangunan RO518542 - Brain Metastases Study
An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases
Sponsor: Hoffmann-La Roche This open-label, single-arm, multicenter study will evaluate the efficacy and safety in patients with metastatic melanoma who developed brain metastases. Patients may or may not have received prior treatment for metastatic melanoma with brain metastases (except treatment with BRAF or MEK inhibitors). Patients will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal. Eligability: Click hereStatus: RecruitingContact: Meenal Rai TEAMBiomarker evaluation of short-term administration of chemotherapeutic or biologic agents in patients with unresectable Stage IV melanoma amenable to pre- and post-treatment biopsyStatus: RecruitingContact: Katherine Carson
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ĉ ď Alex Menzies, Apr 18, 2011 4:17 PM Ċ ď Alex Menzies, Jul 27, 2009 2:33 AM ĉ ď Howard Gurney, Jul 26, 2009 6:38 PM
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