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

CASI Pharmaceuticals, Inc.1 site in 1 country18 target enrollmentOctober 2006

ConditionsOvarian Cancer

DrugsPanzem Nanocrystal Colloidal Dispersion (NCD)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ovarian Cancer
Sponsor: CASI Pharmaceuticals, Inc.
Enrollment: 18
Locations: 1
Primary Endpoint: Assess the safety of oral doses of Panzem NCD administered to patients with recurrent epithelial ovarian cancer
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

November 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

CASI Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•Written informed consent and HIPAA authorization for release of protected health information.
•Have histologically-confirmed:
•epithelial ovarian cancer or
•primary peritoneal carcinomatosis or
•fallopian tube cancer. Enrollment of patients with clear cell histology is encouraged.
•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.
•Be 18 years of age or older at the time of consent.
•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).
•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).
•Have life expectancy of at least 3 months.

Exclusion Criteria

•Be breastfeeding.
•Have any condition that is likely to interfere with regular follow-up.
•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.
•Have participated in any clinical trial involving conventional or investigational drugs or devices within 4 weeks prior to registration for protocol therapy.
•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.
•Have an active infection requiring antibiotic treatment.