The open-label, dose-escalation, multicenter trial will include up to 50 patients who have either failed standard therapy or for whom no standard therapy exists...PROPEL is an international, multicenter, open-label, single-arm study that will enroll 100 patients with relapsed or refractory PTCL who have progressed after at least one prior treatment

The open-label trial is being conducted to determine the drug combination's safety and efficacy in these patients, as well as the highest dose at which KRX-0401 can be safely administered to multiple myeloma patients when combined with Revlimid and dexamethasone

Under the agreement, NIAIS will conduct a Phase I, open-label, does-escalating study to evaluate the safety, tolerability and immunogenicity of EBS-C12 and EBS-C12 in combination with EBS-A42...Sunesis Pharmaceuticals Inc., of South San Francisco, started dosing patients in an open-label, multicenter Phase II trial of SNS-595 as a second-line agent in patients with ovarian cancer who have failed first-line platinum therapy

Following an overall study period of 126 days, patients were eligible for enter an open-label follow-up study, which is ongoing...The double-blind study is comparing 12.5-mg and 25-mg doses to both placebo and open-label Androgel, which is dosed according to physician instructions

CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, reviewed interim efficacy and safety data from an ongoing open-label trial of belinostat (PXD101) monotherapy for cutaneous T-cell lymphoma

The trial is an open-label, dose-ranging Phase IIa study that will enroll up to 18 patients at two sites in Canada

A second study is expected to begin in the first half of next year and follow a similar format in about 300 patients, followed by a third study of open-label, single-arm design to test cetrorelix's safety in about 600 patients

The 215-patient study will test the drug against placebo over 15 months, followed by a 12-month open-label extension period...The 80-subject trial is designed to test MEM 1003 against placebo over a 21-day treatment period, followed by an optional open-label four-week treatment period

Data from the trial, plus results from an open-label extension study, are anticipated to be included in a biologics license application

Celtic Pharmaceutical Holdings LP, of Hamilton, Bermuda, and Neurobiological Technologies Inc., of Emeryville, Calif., said an interim report of an open-label extension study in a Phase III program of Xerecept (corticorelin acetate injection) showed that, of 20 subjects, 11 had reduced their dexamethasone dosage during the four-week study, and two took no concomitant dexamethasone...Xerecept is being developed as a steroid-sparing alternative to dexamethasone, and the open-label study is designed

CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, began an open-label, Phase II trial of intravenous PXD101 for myelodysplastic syndromes (MDS

Genentech Inc., of South San Francisco, and Biogen Idec Inc., of Cambridge, Mass., revealed interim data from their ongoing open-label extension study of Rituxan (rituximab) in patients with rheumatoid arthritis who had an inadequate response to previous treatment with at least one tumor necrosis factor antagonist therapy

Callisto Pharmaceuticals Inc., of New York, said it began dosing in a multicenter, open-label Phase II trial of Atiprimod, an orally available small-molecule drug, for patients with low- to intermediate-grade neuroendocrine carcinomas including advanced carcinoid cancers, with metastatic or unresectable cancer

The open-label study will include 105 patients to show the efficacy of Urocidin in superficial bladder cancer refractory to Bacillus Calmette-Guérin (BCG), a live, attenuated strain of Mycobacterium bovis that is standard therapy in this indication...The open-label trial is designed to determine the product's safety and tolerability in that population, and a total of 15 patients will be treated in cohorts of escalating doses

Callisto Pharmaceuticals Inc., of New York, dosed the first patients in a multicenter, open-label Phase II clinical trial of Atiprimod to treat low- to intermediate-grade neuroendocrine carcinomas, including advanced carcinoid cancers

The randomized, open-label study is being conducted under a special protocol assessment to test the small molecule in combination with first-line chemotherapy, paclitaxel and carboplatin, compared to those two agents alone

The main objective of the Phase II portion of an ongoing Phase I/II open-label study is to evaluate the complete remission rate of Talvesta in relapsed or refractory ALL patients...The company intends to file a biologics license application in the second quarter of 2007, following completion of a 24-week open-label extension phase

The study is an open-label, fixed-dose trial designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of the product

The open-label study will test the vaccine in a dose-escalation trial involving 24 healthy volunteers...MKC-1 is being evaluated in Phase I/II open-label clinical studies against breast cancer and in patients with leukemia