Ovarian CancerPhase 2NCT00400348
Safety and Efficacy Study of Panzem® Nanocrystal Colloidal Dispersion in Patients With Ovarian Cancer
A Phase 2 study testing Panzem Nanocrystal Colloidal Dispersion (NCD) in people with Ovarian Cancer, run by CASI pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Panzem Nanocrystal Colloidal Dispersion (NCD)
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Have ECOG performance status of 0 or 1 as assessed within 14 days prior to registration for protocol therapy.
- 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
- Have no evidence of bowel obstruction, malabsorption, or other contraindication to oral medication.
- 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.
- 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.
Who cannot join
- 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)
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- 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.
- Be receiving concurrent anticoagulation therapy (low dose coumadin for port-a-cath maintenance is allowed).
- Have any additional uncontrolled serious medical condition or psychiatric illness.
- Be receiving combination anti-retroviral therapy for the treatment of immunodeficiency.
- Have brain metastases
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: 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.
- Conditions
- Ovarian Cancer
- Being tested
- Panzem Nanocrystal Colloidal Dispersion (NCD)
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panzem Nanocrystal Colloidal Dispersion (NCD)Drug
Panzem NCD 1,000 mg, four times daily for 28 consecutive days
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety of oral doses of Panzem NCD administered to patients with recurrent epithelial ovarian cancer
Measured: Throughout study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionAug 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- CASI pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniela E. Matei, M.D., Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400348
- Sponsor's protocol ID
- ME-CLN-004
- Status last verified
- Nov 2008
- First submitted
- 14 Nov 2006
- Last updated
- 25 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00400348
- Acronym / sponsor ID
- ME-CLN-004
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CASI pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 16 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Written informed consent and HIPAA authorization for release of protected health information.
- Have histologically-confirmed:
- 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).
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panzem Nanocrystal Colloidal Dispersion (NCD)Panzem NCD 1,000 mg, four times daily for 28 consecutive days | Drug | – |
Primary outcome
Assess the safety of oral doses of Panzem NCD administered to patients with recurrent epithelial ovarian cancer
Time frame: Throughout study participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela E. Matei, M.D. study chair
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panzem Nanocrystal Colloidal Dispersion (NCD) in people with Ovarian Cancer, run by CASI pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the safety of oral doses of Panzem NCD administered to patients with recurrent epithelial ovarian cancer (time frame: Throughout study participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2008.