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Safety and Efficacy Study of Panzem® Nanocrystal Colloidal Dispersion in Patients With Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00400348•CASI Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.
+13 more criteria

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.
+4 more criteria

Locations (1)

Indiana University Cancer Center

Indianapolis, Indiana, United States

Key Dates

Start Date

October 1, 2006

Primary Completion Date

August 1, 2008

Completion Date

November 1, 2008

Last Updated

November 25, 2008

Enrollment

ACTUAL participants

Conditions

Ovarian Cancer

Interventions

Panzem Nanocrystal Colloidal Dispersion (NCD)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

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