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Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

Study Purpose

This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme (GBM)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically confirmed diagnosis of a 1st or 2nd recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma).
  • - 18 years or older.
  • - An interval of at least 2 weeks between prior surgical resection or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks) - Karnofsky performance score equal to or greater than 70% - Hematocrit greater than 29%, absolute neutrophil count greater than 1,500 cells/micro liters, platelets greater than 100,000 cells/ micro liters.
  • - Serum creatinine less than 1.5 X upper limit of normal (ULN), serum SGOT less than 2.5 X ULN; and bilirubin less than 1.5 times ULN.
  • - Signed informed consent form and authorization for use and disclosure of protected health information approved by the IRB prior to patient entry.
  • - Agree to use effective contraceptive methods.

Exclusion Criteria:

  • - Current, active systemic bleeding or excessive risk of bleeding.
  • - Be pregnant or lactating; not employing effective birth control.
  • - Concurrent severe and/or uncontrolled medical disease.
  • - Impairment of gastrointestinal (GI) function/disease.
  • - Requirement for therapy with coumadin (warfarin sodium) - Patient is less than 5 years free of another primary malignancy.
  • - Patients unwilling to or unable to comply with the protocol.
- Grade 2 or greater peripheral sensory neuropathy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00306618
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 CASI Pharmaceuticals, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 David A. Reardon, M.D.
Principal Investigator Affiliation The Brain Center at Duke, Duke University Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Recurrent Glioblastoma Multiforme

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Durham, North Carolina

Status

Address

The Brain Tumor Center, Duke University Medical Center

Durham, North Carolina, 27710

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