Trials / Terminated
TerminatedNCT00900562
Clinical Trial of PM00104 (Zalypsis®) in Patients With Advanced and/or Metastatic Endometrial or Cervical Cancer Previously Treated With One Line of Systemic Chemotherapy
Phase II Clinical and Pharmacokinetic Trial of PM00104 (Zalypsis®) in Patients With Advanced and/or Metastatic Endometrial or Cervical Cancer Previously Treated With One Line of Systemic Chemotherapy
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- PharmaMar · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a phase II clinical and pharmacokinetic trial of PM00104 (Zalypsis®) in patients with advanced and/or metastatic endometrial or cervical cancer previously treated with one line of systemic chemotherapy to evaluate the antitumor activity and to determine the safety profile, the pharmacokinetic profile and the pharmacogenomic profile.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zalypsis ( PM00104) | Zalypsis (PM00104) (2.5 mg/vial) is provided as a powder for concentrate for solution for infusion |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2011-09-01
- Completion
- 2011-09-01
- First posted
- 2009-05-13
- Last updated
- 2021-10-28
- Results posted
- 2021-10-28
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00900562. Inclusion in this directory is not an endorsement.