NCT00900562 is a Phase 2 clinical trial of Zalypsis ( PM00104) in Uterine Cervical Cancer, sponsored by PharmaMar.

Who is sponsoring NCT00900562?

NCT00900562 is sponsored by PharmaMar.

What drugs are being tested in NCT00900562?

Interventions in NCT00900562: Zalypsis ( PM00104).

What condition does NCT00900562 study?

NCT00900562 studies Uterine Cervical Cancer, Endometrial Cancer.

Is NCT00900562 still recruiting?

NCT00900562 is currently terminated. Last updated 30 September 2021.

Are results published for NCT00900562?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-09-30 · How we verify

NCT00900562

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Results posted Last updated 30 September 2021

What this trial tests

Phase 2 trial testing Zalypsis ( PM00104) in Uterine Cervical Cancer in 19 participants. Terminated before completion.

Timeline

1 August 2009

Primary endpoint
1 September 2011

1 September 2011

Quick facts

Lead sponsor	PharmaMar
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	1 August 2009
Primary completion	1 September 2011
Estimated completion	1 September 2011
Sites	4 locations across United States

Drugs / interventions tested

Zalypsis ( PM00104) — full drug profile →

Conditions studied

Uterine Cervical Cancer — all drugs for Uterine Cervical Cancer →
Endometrial Cancer — all drugs for Endometrial Cancer →

Sponsor

PharmaMar — full company profile →

Who can join

18 and older, female only, with Uterine Cervical Cancer or Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Overall Response Rate (ORR)
Time frame: At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years
Overall Response Rate defined as the percentage of patients with either complete response (CR) or partial response (PR) according to RECIST v.1.0. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumo

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Multiple Myeloma: Possible Cure from the Sea.
Capalbo A, Lauritano C. · · 2022 · cited 5× · PMID 35740630 · DOI 10.3390/cancers14122965

Verify or expand the search:

Other recruiting trials for Uterine Cervical Cancer

Currently open trials in the same condition.

NCT04516616 — Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer · Phase 2 · active not recruiting
NCT04857528 — Detecting HPV DNA in Anal and Cervical Cancers · recruiting

Other PharmaMar trials

Trials by the same sponsor.

NCT06088290 — Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants · Phase 3 · recruiting
NCT05841563 — Clinical Trial of PM54 in Advanced Solid Tumors Patients. · Phase 1 · recruiting
NCT05705167 — Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care (NE · Phase 2 · terminated
NCT05121740 — Extension Study in a Cohort of Adult Patients With COVID-19 Infection · Phase 1, PHASE2 · completed
NCT04784559 — Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00900562 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PharmaMar
Last refreshed: 30 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00900562.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing