Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2009-015116-17-IT
EUCTR2009-015116-17-IT
Active, not recruiting
Phase 1

Phase II study with pharmacokinetic and pharmacodynamic evaluations of metronomic chemotherapy with oral Vinorelbine and Dexamethasone in advanced castraction-resistant prostate cancer patients - ProMet-3

ARCO0 sitesDecember 21, 2009
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
DrugsNAVELBINESOLDESAM

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ARCO
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 21, 2009
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
ARCO

Eligibility Criteria

Inclusion Criteria

  • •\-Diagnosis of metastatic or locally advanced castration\-resistant prostate adenocarcinoma,
  • •\-Failure of previous docetaxel\-based chemotherapy or patient unable to receive chemotherapy with docetaxel
  • •\-Increasing PSA serum levels in three consecutive measuraments at least 1 week apart
  • •\-PSA serum value ≥ 2 ng/mL
  • •\-Serum Testosterone \< 50 ng/dL (\< 1\.7 mmol/L)
  • •\-ECOG PS ≤ 2
  • •\-Life expectancy ≥ 3 months
  • •\-Adequate renal function (serum creatinine level \< 1\.25 upper normal limit)
  • •\-Adequate liver function (serum total bilirubin level \< 1\.5 upper normal limit, aspartate aminotransferasi and alanine aminotransferasi \< 3 upper limit)
  • •\-Adequate bone marrow function (leukocytes \> 3000/ mL, platelets \> 100000/mL, haemoglobin level \> 10 g/dL)

Exclusion Criteria

  • •\-Uncontrolled metabolic diseases or active infections
  • •\-One of the following condition in the 12 months before the enrollment:
  • •\- Miocardial infarction
  • •\- Severe or unstable angina
  • •\- Congestive heart failure
  • •\- Pulmonary embolism, stroke, transient ischemic attack
  • •\- Cardiac arrhythmias
  • •\- QT interval \> 450 msec
  • •\- Coronary or periferic arterial bypass
  • •\-Uncontrolledi hyperthension

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Phase 2
A Phase II Study of MR19A13A.
JPRN-jRCT2051220112obuyo Oya12
Unknown
Phase 1
Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders
CTRI/2021/03/032089Catalyst Biosciences Inc8
Active, not recruiting
Phase 1
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Marzeptacog alfa (activated) in Treatment of Episodic Bleeding in Subjects with Factor VII deficiency, Glanzmann thrombasthenia, and Haemophilia A with inhibitors on prophylaxisFactor VII deficiency, Glanzmann thrombasthenia (GT) and Hemophilia A with inhibitors on emicizumab prophylaxis (HAwI-E)MedDRA version: 20.0Level: LLTClassification code 10060612Term: Hemophilia ASystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: PTClassification code 10016079Term: Factor VII deficiencySystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2020-003371-18-ITCatalyst Biosciences, Inc.24
Active, not recruiting
Not Applicable
A Phase I-II Pharmacokinetic/Pharmacodynamic Study of Replagal to Assess the Effects of Alternative Dose and Regimen in Patients with Fabry Disease (TKT027) - TKT027
EUCTR2004-000772-14-CZTKT Inc20
Not yet recruiting
Phase 2
A Clinical Trial of Spectrila® in Adult Subjects with Newly Diagnosed Acute Lymphoblastic LeukaemiaAcute Lymphoblastic LeukaemiaC91.0
RBR-3gz8hcHospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP