NCT00359294 is a Phase 1 clinical trial of PM00104 in Solid Tumors, sponsored by PharmaMar.

Who is sponsoring NCT00359294?

NCT00359294 is sponsored by PharmaMar.

What drugs are being tested in NCT00359294?

Interventions in NCT00359294: PM00104.

What condition does NCT00359294 study?

NCT00359294 studies Solid Tumors, Lymphoma.

Is NCT00359294 still recruiting?

NCT00359294 is currently terminated. Last updated 7 July 2021.

Are results published for NCT00359294?

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

Last reviewed 2021-07-07 · How we verify

NCT00359294

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

A Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Study of PM00104 Administered Intravenously Over 1 Hour Daily for 5 Days, Every 3 Weeks, to Subjects With Advanced Malignant Solid Tumors or Lymphoma.

Terminated Phase 1 Results posted Last updated 7 July 2021

What this trial tests

Phase 1 trial testing PM00104 in Solid Tumors in 12 participants. Terminated before completion.

Timeline

1 May 2006

Primary endpoint
1 September 2008

1 September 2008

Quick facts

Lead sponsor	PharmaMar
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 May 2006
Primary completion	1 September 2008
Estimated completion	1 September 2008
Sites	2 locations across United States

Drugs / interventions tested

PM00104 — full drug profile →

Conditions studied

Solid Tumors — all drugs for Solid Tumors →
Lymphoma — all drugs for Lymphoma →

Sponsor

PharmaMar — full company profile →

Who can join

18 and older, any sex, with Solid Tumors or Lymphoma. 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.

Patients With Dose Limiting Toxicities (DLT)
Time frame: During the first cycle (21 days)
DLTs were defined as follows: * Hematological adverse events: * Any grade 4 neutropenia (absolute neutrophil count (ANC) \< 0.5 x109/l) for longer than five days; * Any grade 4 neutropenia accompanied by fever (at least 38.5°C); * Any grade 4 neutropenia and sepsis or other severe infection; * Any grade 4 thrombocytopenia. * Any other grade 3/4 non-hematological adverse event (AE) and an

Sponsor's own description

Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study. The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended dose (RD) of PM00104, administered intravenously over 1 hour daily for 5 days every 3 weeks (this is considered as 1 cycle) to subjects with advanced malignant solid tumors or lymphoma.

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 Solid Tumors

Currently open trials in the same condition.

NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
NCT07395258 — A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Differe · Phase 1 · recruiting
NCT07505069 — Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors · EARLY_PHASE1 · 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 NCT00359294 (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: 7 July 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/NCT00359294.

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