Ovarian NeoplasmsPhase 2NCT00035100
EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
A Phase 2 study testing epothilone b in people with Ovarian Neoplasms and Peritoneal Neoplasms, run by Novartis Pharmaceuticals at 8 sites in 5 countries.
Trial summary
This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause ovarian, fallopian, or peritoneal cancers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms
- What is being tested?
- epothilone b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Sep 2001to Jun 2003
- 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
- The following patients may be eligible for the study:
- Histologically or cytologically documented evidence of ovarian, primary Fallopian or primary peritoneal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
- Must have a life expectancy of greater than three (3) months
- Prior failure to respond following front-line treatment with a taxane and platinum (or a combination therapy) may be eligible.
Who cannot join
- The following patients are not eligible for the study:
- Patients with radiation therapy or chemotherapy within the last four weeks
- Patients who have had any chemotherapy not containing a taxane and platinum for their disease
- Patients with borderline ovarian and macropapillary tumors
- Patients with unresolved bowel obstruction
- Patients with symptomatic CNS metastases or leptomeningeal involvement
Show all 13Show fewer
- Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
- Patients with severe cardiac insufficiency
- Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
- History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
- Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
- HIV+ patients
- Pregnant or lactating females.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Netherlands3 sites
Novartis Investigative Site
Amsterdam, 1066 CX
Novartis Investigative Site
Enschede, Netherlands, 7513 ER
Novartis Investigative Site
Zwolle, 8025 AB
Slovakia2 sites
Novartis Investigative Site
Bratislava, 812 50
Novartis Investigative Site
Košice, 04190
United States1 site
Novartis Investigative Site
New Brunswick, New Jersey, 08901
About this study
Official title: An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.
- Being tested
- epothilone b
- Keywords
- ovarian, ovary, peritoneal cancer, fallopian cancer, cancer, tumor, tumour, neoplasm, carcinoma, intravenous, epothilone
- Medical subject headings
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epothilone bDrug
Also called EPO906
| Study group | Role | What they receive |
|---|---|---|
| EPO906 | Experimental | Not described Receives: Drug: epothilone b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate
tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: Every 2 cycles
Secondary outcomes (5)
Time to disease progression
Measured: from start of treatment to documented disease progression, death from study indication, or the date of last follow-up
Overall survival
Measured: measured from the start of treatment to the date of death or the last date the patient was known to be alive.
Duration of response
duration of response in patients with complete response (CR) or partial response (PR)
Measured: Every 3 months
recording all adverse events (AEs) and serious adverse events (SAEs)
Safety and tolerability of patupilone by monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry and urine lalues, vital signs, ECG and physical examinations
Measured: Every 3 months
pharmacogenetic analyses with blood and tumor samples from these patients
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startSep 2001
- Primary completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035100
- Sponsor's protocol ID
- CEPO906A2203
- Status last verified
- Apr 2012
- First submitted
- 2 May 2002
- Last updated
- 16 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT00035100
- Acronym / sponsor ID
- CEPO906A2203
- Keywords
- ovarian, ovary, peritoneal cancer, fallopian cancer, cancer, tumor, tumour, neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Jun 2003 (actual)
- First posted
- 3 May 2002 (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.
This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPO906 | Experimental | Drug: epothilone b |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically documented evidence of ovarian, primary Fallopian or primary peritoneal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
- Must have a life expectancy of greater than three (3) months
- Prior failure to respond following front-line treatment with a taxane and platinum (or a combination therapy) may be eligible.
Key exclusion criteria (13 listed)
- Patients with radiation therapy or chemotherapy within the last four weeks
- Patients who have had any chemotherapy not containing a taxane and platinum for their disease
- Patients with borderline ovarian and macropapillary tumors
- Patients with unresolved bowel obstruction
- Patients with symptomatic CNS metastases or leptomeningeal involvement
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 |
|---|---|---|
| epothilone bAlso: EPO906 | Drug | EPO906 |
Primary outcome
Tumor response rate
Time frame: Every 2 cycles
tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
5 secondary outcomes
Time to disease progression
Time frame: from start of treatment to documented disease progression, death from study indication, or the date of last follow-up
Overall survival
Time frame: measured from the start of treatment to the date of death or the last date the patient was known to be alive.
Duration of response
Time frame: Every 3 months
recording all adverse events (AEs) and serious adverse events (SAEs)
Time frame: Every 3 months
pharmacogenetic analyses with blood and tumor samples from these patients
Time frame: Every 3 months
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 16 Apr 2012.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epothilone b in people with Ovarian Neoplasms and Peritoneal Neoplasms, run by Novartis Pharmaceuticals at 8 sites in 5 countries.
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 4 inclusion and 13 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 16 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands, Slovakia, United States, Canada, United Kingdom. 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?
Tumor response rate (time frame: Every 2 cycles). 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 16 Apr 2012.