Safety and Efficacy Study of Panzem® Nanocrystal Colloidal Dispersion in Patients With Ovarian Cancer

November 24, 2008 updated by: CASI Pharmaceuticals, Inc.

A Phase 2, Open-Label, Safety and Efficacy Study of Panzem® Nanocrystal Colloidal Dispersion Administered Orally in Patients With Recurrent or Resistant Epithelial Ovarian Cancer

The purpose of this study is to evaluate the efficacy, limited pharmacokinetics (PK), and safety of 1,000 mg of Panzem® NCD administered orally four times a day to patients with recurrent or resistant epithelial ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Written informed consent and HIPAA authorization for release of protected health information.

  2. Have histologically-confirmed:

    • epithelial ovarian cancer or
    • primary peritoneal carcinomatosis or
    • fallopian tube cancer. Enrollment of patients with clear cell histology is encouraged.
  3. Have measurable disease according to RECIST or detectable disease by 1) CA-125 at least twice the ULN within 14 days prior to registration for protocol therapy; 2) Ascites and/or pleural effusion attributed to tumor; 3) solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definitions for target lesions. Radiographic assessments must be obtained within 28 days prior to registration for protocol therapy.
  4. Be 18 years of age or older at the time of consent.
  5. Be at least 4 weeks since last anti-cancer treatment, radiation or surgery at the time of registration for protocol therapy (with the exception of hormonal therapy, where a 1 week wash-out period is sufficient; minor surgeries, such as catheter placement or removal within 1 week from enrollment are allowed).
  6. Have failed at least one prior platinum based chemotherapeutic regimen. (Platinum failure is defined as Platinum-refractory (progression while receiving a platinum-containing regimen) or platinum-resistant (disease progression within 6 months from completion of platinum-containing regimen).
  7. Have life expectancy of at least 3 months.
  8. Have ECOG performance status of 0 or 1 as assessed within 14 days prior to registration for protocol therapy.

  9. Have near-normal organ function, as evidenced by laboratory data within 14 days prior to registration for protocol therapy:

    • Aspartate aminotransferase and alanine aminotransferase less than 2.5 times upper limit of normal (ULN)
    • Total bilirubin less than 1.5 times ULN
    • Alkaline phosphatase less than 2.5 times ULN
    • Absolute neutrophil count greater than or equal to 1,500 cells/mm3
    • White blood cell count greater than or equal to 3,000 cells/mm3
    • Hemoglobin greater than or equal to 9.0 g/dL
    • Platelets greater than 75,000/mm3
    • Creatinine levels less than 1.5 times ULN
  10. Have no evidence of bowel obstruction, malabsorption, or other contraindication to oral medication.
  11. Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment.
  12. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Subjects are considered not of childbearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.

Exclusion Criteria:

  1. Be breastfeeding.
  2. Have any condition that is likely to interfere with regular follow-up.
  3. Have a history of myocardial infarction or angina pectoris or angina equivalent within 6 months prior to registration for protocol therapy (the patient may be on anti-anginal medications if the symptoms can be entirely controlled), or have uncontrolled hypertension or congestive heart failure.
  4. Have participated in any clinical trial involving conventional or investigational drugs or devices within 4 weeks prior to registration for protocol therapy.

  5. Have had any active cancer in addition to the epithelial ovarian cancer within the last 5 years, with the exception of:

    • superficial skin cancer (basal cell or squamous cell skin carcinoma)
    • carcinoma in situ of the cervix
    • Stage I endometrial cancer with less than 50% invasion of the myometrium, or
    • other adequately treated Stage I or II cancer in complete remission.
  6. Have an active infection requiring antibiotic treatment.
  7. Be receiving concurrent anticoagulation therapy (low dose coumadin for port-a-cath maintenance is allowed).
  8. Have any additional uncontrolled serious medical condition or psychiatric illness.
  9. Be receiving combination anti-retroviral therapy for the treatment of immunodeficiency.
  10. Have brain metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the safety of oral doses of Panzem NCD administered to patients with recurrent epithelial ovarian cancer
Time Frame: Throughout study participation
Throughout study participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CASI Pharmaceuticals, Inc.

Investigators

  • Study Chair: Daniela E. Matei, M.D., Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

November 14, 2006

First Submitted That Met QC Criteria

November 15, 2006

First Posted (Estimate)

November 16, 2006

Study Record Updates

Last Update Posted (Estimate)

November 25, 2008

Last Update Submitted That Met QC Criteria

November 24, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME-CLN-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on Panzem Nanocrystal Colloidal Dispersion (NCD)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe