Ovarian Cancer RecurrentPhase 2ESP2011-002NCT01485848
EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer
A Phase 2 study testing EP-100 and Paclitaxel in people with Ovarian Cancer Recurrent, run by Esperance Pharmaceuticals Inc at 15 sites in United States.
Trial summary
Primary Objectives: o Run-in Phase: Determine a dose of EP-100 at which the initial benefit/risk of paclitaxel combined with EP-100 can be studied. o Randomized Phase: Compare the anti-tumor effects of EP-100 combined with weekly paclitaxel versus paclitaxel alone in patients with 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 Recurrent
- What is being tested?
- EP-100 and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 15 sitesUnited States
- Study dates
- Feb 2012to May 2014
- 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
- Adult patients with histologically confirmed epithelial ovarian carcinomas; these will include primary peritoneal and fallopian tube carcinomas. Patient's tumor shown to be positive for the LHRH-receptors by standardized immunocytochemistry performed at the study's central laboratory.
- Reliable cancer treatment history documenting advanced disease in patients who have progressed during or recurred after treatment with a paclitaxel and/or platinum regimen for advanced disease.
- Evaluable disease based on criteria of the Gynecologic Intergroup Response Evaluation Criteria in in Solid Tumors.
- Karnofsky performance status >/= 70%.
Who cannot join
- Significant cardiac disease.
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
- Pregnant or nursing women.
- Treatment with radiation therapy or investigational therapy within 4 weeks prior to Day 1. Had received chemotherapy prior to study entry equivalent to 3 to 5 half-lives of that chemotherapy agent or 4 weeks prior to study entry (whichever is shorter) with resolution of any side effects from that previous therapy (6 weeks for nitrosoureas or Mitomycin C.)
- Subjects with known central nervous system (CNS) metastases, either previously treated or current.
- Disease-free and off therapy for any other cancer within 5 years, except for adequately treated basal cell or squamous cell skin cancer or cervical intraepithelial neoplasia (CIN).
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- Had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1. o Had minor surgery (superficial incisions unlikely to obscure bleeding or infections) within 2 weeks prior to Day 1.
- Potentially life-threatening disease (hypercalcemia, spinal cord compression) whose disease may progress acutely during therapy.
- Unwilling or unable to comply with procedures required in this protocol.
- Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Susceptibility to histamine release.
- Chronic treatment with corticosteroids.
- Baseline QTc exceeding 450 msec (by Bazett's formula) and/or patients receiving class 1A or class III antiarrythmic agents.
- Serious nonmalignant disease.
- Subjects who are currently receiving any other investigational agent.
- Inadequate renal and liver functions and bone marrow reserve.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Investigational Site Number 840503
Bozeman, Montana, 58715
Investigational Site Number 840010
Covington, Louisiana, 70433
Investigational Site Number 840001
Greenbrae, California, 94904-2011
Investigational Site Number 840006
Houston, Texas, 77030
Investigational Site Number 840603
Kennewick, Washington, 99336
Investigational Site Number 840007
Louisville, Kentucky, 40202
Investigational Site Number 840004
Middletown, Ohio, 45042
Investigational Site Number 840103
Mount Vernon, Washington, 98273
Investigational Site Number 840008
Portland, Oregon, 97227-1191
Investigational Site Number 840005
San Francisco, California, 94115
Investigational Site Number 840403
Seattle, Washington, 98112
Investigational Site Number 840003
Seattle, Washington, 98115
Investigational Site Number 840011
Shreveport, Louisiana, 71103
Investigational Site Number 840303
Tacoma, Washington, 98415-0299
Investigational Site Number 840203
Wenatchee, Washington, 98801
About this study
Official title: EP-100, a Novel LHRH Receptor-Targeted, Membrane-Disrupting Peptide, Plus Paclitaxel Versus Paclitaxel Alone for Refractory or Recurrent Ovarian Cancer: A Phase II, Randomized, Multicenter Trial
Primary Objectives: o Run-in Phase: Determine a dose of EP-100 at which the initial benefit/risk of paclitaxel combined with EP-100 can be studied. o Randomized Phase: Compare the anti-tumor effects of EP-100 combined with weekly paclitaxel versus paclitaxel alone in patients with ovarian cancer. Secondary Objectives: o Randomized Phase: Quantify any significant changes in the safety profile of weekly paclitaxel alone compared to the doublet combination of paclitaxel with EP-100. o Determine an initial benefit/risk profile for this new drug combination.
Read the detailed description
Total duration of the study for each participant is 9 to 10 months, consisting of a 1 month screening period, a 6 to 7 months treatment period, and a 30 day follow-up. All patients with stable disease or who have achieved partial or complete response and for whom dosing has been safe and reasonably well-tolerated may continue additional treatment cycles on the same regimen. Any patient whose imaging assessment shows disease progression after receiving at least two cycles of single agent weekly paclitaxel on ARM 1 may then be offered treatment with the combination of EP-100 plus paclitaxel in the same dose regimen as ARM 2.
- Conditions
- Ovarian Cancer Recurrent
- Being tested
- EP-100, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP-100Drug
Pharmaceutical form:Solution Route of administration: Intravenous
PaclitaxelDrug
Pharmaceutical form:Solution Route of administration: Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel | Active comparator | A single 1 hour intravenous infusion every week for 6 cycles (each cycle is 4 weeks) Receives: Drug: EP-100 |
| Paclitaxel + EP-100 | Experimental | Paclitaxel every week plus EP-100 twice weekly by 1 hour intravenous infusion for the first 3 weeks of each 4 week cycle for 6 cycles (each cycle is 4 weeks) Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicities (DLTs) at different doses
Measured: Up to 30 weeks
Overall Response Rate (ORR)
Measured: Up to 30 weeks
Secondary outcomes (5)
Time to Progression (TTP) - Time
Measured: Up to 18 months
Progression-free Survival - Time
Measured: Up to 18 months
Overall Survival (OS) - Time
Measured: Up to 18 months
Duration of Response - Time
Measured: Up to 18 months
Number of Participants with Adverse Events
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer RecurrentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esperance Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485848
- Sponsor's protocol ID
- ACT12601
- Other IDs
- U1111-1124-2062
- Acronym
- ESP2011-002
- Status last verified
- Jun 2014
- First submitted
- 2 Dec 2011
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EP-100, a Novel LHRH Receptor-Targeted, Membrane-Disrupting Peptide, Plus Paclitaxel Versus Paclitaxel Alone for Refractory or Recurrent Ovarian Cancer: A Phase II, Randomized, Multicenter Trial
- ClinicalTrials.gov ID
- NCT01485848
- Acronym / sponsor ID
- ESP2011-002 / ACT12601
- Conditions
- Ovarian Cancer Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Esperance Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Dec 2011 (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.
Primary Objectives: o Run-in Phase: Determine a dose of EP-100 at which the initial benefit/risk of paclitaxel combined with EP-100 can be studied. o Randomized Phase: Compare the anti-tumor effects of EP-100 combined with weekly paclitaxel versus paclitaxel alone in patients with ovarian cancer. Secondary Objectives: o Randomized Phase: Quantify any significant changes in the safety profile of weekly paclitaxel alone compared to the doublet combination of paclitaxel with EP-100. o Determine an initial benefit/risk profile for this new drug combination.
Detailed description
Total duration of the study for each participant is 9 to 10 months, consisting of a 1 month screening period, a 6 to 7 months treatment period, and a 30 day follow-up. All patients with stable disease or who have achieved partial or complete response and for whom dosing has been safe and reasonably well-tolerated may continue additional treatment cycles on the same regimen. Any patient whose imaging assessment shows disease progression after receiving at least two cycles of single agent weekly paclitaxel on ARM 1 may then be offered treatment with the combination of EP-100 plus paclitaxel in the same dose regimen as ARM 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel | Active comparator | Drug: EP-100A single 1 hour intravenous infusion every week for 6 cycles (each cycle is 4 weeks) |
| Paclitaxel + EP-100 | Experimental | Drug: PaclitaxelPaclitaxel every week plus EP-100 twice weekly by 1 hour intravenous infusion for the first 3 weeks of each 4 week cycle for 6 cycles (each cycle is 4 weeks) |
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)
- Adult patients with histologically confirmed epithelial ovarian carcinomas; these will include primary peritoneal and fallopian tube carcinomas. Patient's tumor shown to be positive for the LHRH-receptors by standardized immunocytochemistry performed at the study's central laboratory.
- Reliable cancer treatment history documenting advanced disease in patients who have progressed during or recurred after treatment with a paclitaxel and/or platinum regimen for advanced disease.
- Evaluable disease based on criteria of the Gynecologic Intergroup Response Evaluation Criteria in in Solid Tumors.
- Karnofsky performance status >/= 70%.
Key exclusion criteria (17 listed)
- Significant cardiac disease.
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
- Pregnant or nursing women.
- Treatment with radiation therapy or investigational therapy within 4 weeks prior to Day 1. Had received chemotherapy prior to study entry equivalent to 3 to 5 half-lives of that chemotherapy agent or 4 weeks prior to study entry (whichever is shorter) with resolution of any side effects from that previous therapy (6 weeks for nitrosoureas or Mitomycin C.)
- Subjects with known central nervous system (CNS) metastases, either previously treated or current.
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 |
|---|---|---|
| EP-100Pharmaceutical form:Solution Route of administration: Intravenous | Drug | Paclitaxel |
| PaclitaxelPharmaceutical form:Solution Route of administration: Intravenous | Drug | Paclitaxel + EP-100 |
Primary outcome
Number of patients with dose limiting toxicities (DLTs) at different doses
Time frame: Up to 30 weeks
Overall Response Rate (ORR)
Time frame: Up to 30 weeks
5 secondary outcomes
Time to Progression (TTP) - Time
Time frame: Up to 18 months
Progression-free Survival - Time
Time frame: Up to 18 months
Overall Survival (OS) - Time
Time frame: Up to 18 months
Duration of Response - Time
Time frame: Up to 18 months
Number of Participants with Adverse Events
Time frame: Up to 18 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 10 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EP-100 and Paclitaxel in people with Ovarian Cancer Recurrent, run by Esperance Pharmaceuticals Inc at 15 sites 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 4 inclusion and 17 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 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Number of patients with dose limiting toxicities (DLTs) at different doses (time frame: Up to 30 weeks). The study lists 2 primary outcomes in all. 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 10 Jun 2014.