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A Phase I Study of Zalypsis (PM00104) in Subjects With Advanced Malignant Solid Tumors or Lymphoma

NCT00359294 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-07-28

Study results available
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Summary

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.

Conditions

Interventions

DRUG

PM00104

Intravenously over 1 hour daily for 5 days, every 3 weeks.

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Principal Investigators

  • Roger Bryan Cohen, MD · Fox Chase Cancer Center

  • Eunice Lee Kwak, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00359294 on ClinicalTrials.gov