MelanomaPhase 2NCT00035165
EPO906 Therapy in Patients With Advanced Melanoma
A Phase 2 study testing epothilone b in people with Melanoma, run by Novartis Pharmaceuticals at 6 sites in United States.
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 melanoma. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Melanoma
- What is being tested?
- epothilone b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2002to May 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following patients may be eligible for this study:
- Patients with advanced metastatic melanoma defined as poor prognosis Stage III melanoma and Stage IV disease, which has been histologically or cytologically confirmed with at least one measurable lesion not including bone metastases (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
- Patients with poor prognosis Stage III melanoma must have locally advanced unresectable disease that is measurable (repeat histological or cytological confirmation is not necessary at the time of study entry if previous results are available and there is no question in the investigator's opinion as to the diagnosis)
- Must have a life expectancy of greater than three (3) months
- Prior immunotherapy with interferon alpha in the adjuvant setting is permitted, but must have been completed > 4 weeks prior to treatment
- Prior vaccine therapy is permitted, but must have been completed > 4 weeks prior to treatment
- Patient has no major impairment of hematological function (red blood cell transfusions and repeat evaluations for study entry are allowed).
Who cannot join
- The following patients are not eligible for this study:
- Patients with choroidal ocular melanoma
- Patients with symptomatic CNS metastases or leptomeningeal involvement
- Patients with renal or hepatic dysfunction
- Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
- Patients with severe cardiac insufficiency
Show all 14Show fewer
- 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
- Patients who have received any investigational compound or anti-melanoma vaccine within the past 28 days or those who are planning to receive other investigational drugs while participating in the study
- Patients who had received radiotherapy within the last 4 weeks to a site which will be the reference for disease assessment (however, new or progressive lesions in the previously irradiated fields of these patients may be used for disease assessment and patients must have recovered from the side effects of radiotherapy)
- Patients receiving chemotherapy within the last four weeks
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado
Aurora, Colorado, 80045
Duke University Medical Center
Durham, North Carolina, 27710
UPMC Health Systems
Pittsburgh, Pennsylvania, 15213
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Comprehensive Cancer Center@ Our Lady if Mercy Medical Center
The Bronx, New York, 10466-2697
Oklahoma Oncology, Inc.
Tulsa, Oklahoma, 74104
About this study
Official title: An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Melanoma
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 melanoma.
- Conditions
- Melanoma
- Being tested
- epothilone b
- Keywords
- melanoma, cancer, tumor, tumour, malignant, metastatic, intravenous, epothilone
- Medical subject headings
- Melanoma, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epothilone bDrug
Also called Patupilone, EPO906
intravenous 2.5 mg/m2 as a 5 minutes bolus infusion once every week for three weeks followed by one week off
| 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 (complete response (CR), partial response (PR), stable disease (SD))
Objective tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines assessed by radiologic techniques and/or physical examination.
Measured: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Secondary outcomes (5)
Number and percentage of patients with Adverse events
Safety and tolerabilty of EPO906: Safety assessments consisted of monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs and the performance status.
Measured: as necessary
Objective response rate (ORR)
Measured: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Time to disease progression (TTP)
Measured: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Overall Survival (OS)
Measured: from the date of the first dose of treatment to date of death from any cause, or the last date the patient is known to be alive
Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma
For biomarker development
Measured: prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment
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 startMar 2002
- Primary completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 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
- NCT00035165
- Sponsor's protocol ID
- CEPO906A2206
- Status last verified
- Apr 2012
- First submitted
- 2 May 2002
- Last updated
- 25 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 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 Melanoma
- ClinicalTrials.gov ID
- NCT00035165
- Acronym / sponsor ID
- CEPO906A2206
- Conditions
- Melanoma
- Keywords
- melanoma, cancer, tumor, tumour, malignant, metastatic, intravenous, epothilone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- May 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 melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with advanced metastatic melanoma defined as poor prognosis Stage III melanoma and Stage IV disease, which has been histologically or cytologically confirmed with at least one measurable lesion not including bone metastases (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
- Patients with poor prognosis Stage III melanoma must have locally advanced unresectable disease that is measurable (repeat histological or cytological confirmation is not necessary at the time of study entry if previous results are available and there is no question in the investigator's opinion as to the diagnosis)
- Must have a life expectancy of greater than three (3) months
- Prior immunotherapy with interferon alpha in the adjuvant setting is permitted, but must have been completed > 4 weeks prior to treatment
- Prior vaccine therapy is permitted, but must have been completed > 4 weeks prior to treatment
Key exclusion criteria (14 listed)
- Patients with choroidal ocular melanoma
- Patients with symptomatic CNS metastases or leptomeningeal involvement
- Patients with renal or hepatic dysfunction
- Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
- Patients with severe cardiac insufficiency
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: Patupilone, EPO906intravenous 2.5 mg/m2 as a 5 minutes bolus infusion once every week for three weeks followed by one week off | Drug | EPO906 |
Primary outcome
Tumor response (complete response (CR), partial response (PR), stable disease (SD))
Time frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Objective tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines assessed by radiologic techniques and/or physical examination.
5 secondary outcomes
Number and percentage of patients with Adverse events
Time frame: as necessary
Objective response rate (ORR)
Time frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Time to disease progression (TTP)
Time frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Overall Survival (OS)
Time frame: from the date of the first dose of treatment to date of death from any cause, or the last date the patient is known to be alive
Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma
Time frame: prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment
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 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
6 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 epothilone b in people with Melanoma, run by Novartis Pharmaceuticals at 6 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 7 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 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 6 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?
Tumor response (complete response (CR), partial response (PR), stable disease (SD)) (time frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)). 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 Apr 2012.