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Clinical Trials/EUCTR2008-002668-32-FI
EUCTR2008-002668-32-FI
Active, not recruiting
Not Applicable

An Open, Randomized, Multicenter Study in Patients with Recurrent Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficacy and Safety of paclitaxel (micellar) nanoparticles and paclitaxel(Cremophor® EL)

Oasmia Pharmaceutical AB0 sites650 target enrollmentMay 19, 2009
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ConditionsHistological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.MedDRA version: 9.1Level: LLTClassification code 10066697Term: Ovarian cancer recurrentMedDRA version: 9.1Level: LLTClassification code 10052171Term: Peritoneal carcinomaMedDRA version: 9.1Level: LLTClassification code 10016180Term: Fallopian tube cancer
DrugsTaxol®Carboplatin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
Sponsor
Oasmia Pharmaceutical AB
Enrollment
650
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 19, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
  • •2\.Patients relapsing \> 6 months after end of first line or second line treatment including platinum based therapy. Prior therapy and duration of response will be documented in the CRF for descriptive analysis.
  • •3\.CA 125 \>2 x upper normal limit (UNL) documented at two occasions, with more than one week interval, according to appendix I, patient groups A and B, measurable/non\- measurable disease.
  • •4\.Age \> 18 years
  • •5\.Eastern Cooperative Oncology Group (ECOG) performance score 0\-2
  • •6\.Life expectancy \>12 weeks
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\.Patient has peripheral neuropathy of grade \= 2 per NCI\- CTCAE version 3\.0
  • •2\.Surgical procedure due to progressive disease within 4 weeks of any of the CA\- 125 measurements
  • •3\.Patient receiving concurrent hormonal, immuno\-, or radiotherapy. Treatment must have stopped for at least 4 weeks before start of drug treatment (Day 1 , Cycle 1\).
  • •4\.Bowel obstruction at screening

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
An Open, Randomized, Multicenter Study in Patients with Recurrent Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficacy and Safety of paclitaxel (micellar) nanoparticles and paclitaxel(Cremophor® EL)
EUCTR2008-002668-32-CZOasmia Pharmaceutical AB650
Active, not recruiting
Not Applicable
A Clinical Study to Compare Efficacy and Safety of Two Formulations ofPaclitaxel in Patients with Recurrent Epithelial Ovarian Cancer, PrimaryPeritoneal Cancer or Fallopian Tube Cancer.Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.MedDRA version: 15.0Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2008-002668-32-LTOasmia Pharmaceutical AB850
Active, not recruiting
Not Applicable
Study of Paclitaxel in Patients With Ovarian Cancer
EUCTR2008-002668-32-SEOasmia Pharmaceutical AB850
Active, not recruiting
Not Applicable
An Open, Randomized, Multicenter Study in Patients with Recurrent Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficacy and Safety of paclitaxel (micellar) nanoparticles and paclitaxel(Cremophor® EL)
EUCTR2008-002668-32-LVOasmia Pharmaceutical AB650
Active, not recruiting
Phase 1
An Open, Randomized, Multicenter Study in Patients with Recurrent Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficacy and Safety of paclitaxel (micellar) nanoparticles and paclitaxel(Cremophor® EL)Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.MedDRA version: 14.0Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2008-002668-32-SKOasmia Pharmaceutical AB850