CarcinoidPhase 2NCT00050349
EPO906 in Carcinoid and Other Neuroendocrine Tumors
A Phase 2 study testing EPO906 epothilone B in people with Carcinoid and Neuroendocrine Tumors, run by Novartis Pharmaceuticals at 5 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 metastatic carcinoid and other neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid, Neuroendocrine Tumors
- What is being tested?
- EPO906 epothilone B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2002to Apr 2007
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biopsy-proven metastatic carcinoid tumors or other neuroendocrine tumors (Islet cell, Gastrinomas and VIPomas) with at least one measurable lesion (other than bone) that has either not been previously irradiated or if previously irradiated has demonstrated progression since the radiation therapy
- The patient has no major impairment of renal or hepatic function, as defined by the following laboratory parameters: total bilirubin <1.5 X ULN; AST, ALT<2.5X ULN (<5 X ULN if liver metastases are present)
- Patients on Sandostatin Lar (long acting somatostatin analogue) must be on a stable dose for 30 days prior to study entry and short acting somatostatin analogues must be judged to be on a clinically stable dose by the investigator prior to study entry
- Must have a life expectancy of greater than three (3) months
- Karnofsky Performance Status > 60
- Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal.)
Who cannot join
- Patients with symptomatic CNS metastases or leptomeningeal involvement
- Patients with known brain metastases, unless these metastases have been treated and/or have been stable for at least six months prior to study start. Subjects with a history of brain metastases must have a head CT with contrast to document either response or progression.
- Patients with bone metastases as the only site(s) of measurable disease
- Patients with hepatic artery chemoembolization within the last 6 months (one month if there are other sites of measurable disease)
- Patients who have been previously treated with radioactive directed therapies
- Patients who have been previously treated with epothilone
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 warfarin (1 mg or less) for the maintenance of in-dwelling lines or ports
- Patients taking any experimental therapies history of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ
- Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
- Patients with a medical or psychiatric illness that would preclude study or informed consent and/or history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits
- HIV+ patients
- Pregnant or lactating females.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern University
Chicago, Illinois, 60611
University of Iowa Health Care
Iowa City, Iowa, 52242-1091
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)
New Orleans, Louisiana, 70115
Weill Medical College of Cornell Univ.
New York, New York, 10021
Oregon Health Sciences University
Portland, Oregon, 97201
About this study
Official title: EPO906 Therapy in Patients With Metastatic Carcinoid Tumors and Other Neuroendocrine Tumors
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 metastatic carcinoid and other neuroendocrine tumors.
- Conditions
- Carcinoid, Neuroendocrine Tumors
- Being tested
- EPO906 epothilone B
- Keywords
- cancer, tumor, tumour, neoplasm, carcinoma, carcinoid, neuroendocrine, Islet cell, Gastrinoma, VIPoma, metastatic, intravenous, epothilone
- Medical subject headings
- Carcinoid Tumor, Neuroendocrine Tumors, Neoplasms, Carcinoma, Gastrinoma, Vipoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPO906 epothilone BDrug
Also called patupilone
| Study group | Role | What they receive |
|---|---|---|
| EPO906 | Experimental | Not described Receives: Drug: EPO906 epothilone B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: every 12 weeks
Secondary outcomes (2)
Time to progression
Measured: until documented disease progression, death or date of follow up
Overall survival
Measured: after treatment, every 3 months (maximum of 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2002 (estimated)
- Study startJul 2002
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinoidStudies 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
- 33 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
- NCT00050349
- Sponsor's protocol ID
- CEPO906A2212
- Status last verified
- Mar 2013
- First submitted
- 4 Dec 2002
- Last updated
- 1 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPO906 Therapy in Patients With Metastatic Carcinoid Tumors and Other Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT00050349
- Acronym / sponsor ID
- CEPO906A2212
- Conditions
- Carcinoid, Neuroendocrine Tumors
- Keywords
- cancer, tumor, tumour, neoplasm, carcinoma, carcinoid, neuroendocrine, Islet cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 5 Dec 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 metastatic carcinoid and other neuroendocrine tumors.
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: EPO906 epothilone B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with biopsy-proven metastatic carcinoid tumors or other neuroendocrine tumors (Islet cell, Gastrinomas and VIPomas) with at least one measurable lesion (other than bone) that has either not been previously irradiated or if previously irradiated has demonstrated progression since the radiation therapy
- The patient has no major impairment of renal or hepatic function, as defined by the following laboratory parameters: total bilirubin <1.5 X ULN; AST, ALT<2.5X ULN (<5 X ULN if liver metastases are present)
- Patients on Sandostatin Lar (long acting somatostatin analogue) must be on a stable dose for 30 days prior to study entry and short acting somatostatin analogues must be judged to be on a clinically stable dose by the investigator prior to study entry
- Must have a life expectancy of greater than three (3) months
- Karnofsky Performance Status > 60
Key exclusion criteria (13 listed)
- Patients with symptomatic CNS metastases or leptomeningeal involvement
- Patients with known brain metastases, unless these metastases have been treated and/or have been stable for at least six months prior to study start. Subjects with a history of brain metastases must have a head CT with contrast to document either response or progression.
- Patients with bone metastases as the only site(s) of measurable disease
- Patients with hepatic artery chemoembolization within the last 6 months (one month if there are other sites of measurable disease)
- Patients who have been previously treated with radioactive directed therapies
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 |
|---|---|---|
| EPO906 epothilone BAlso: patupilone | Drug | EPO906 |
Primary outcome
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: every 12 weeks
2 secondary outcomes
Time to progression
Time frame: until documented disease progression, death or date of follow up
Overall survival
Time frame: after treatment, every 3 months (maximum of 12 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 1 Mar 2017.
Related trials for Carcinoid
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Natural History of Familial Carcinoid Tumor
Carcinoid
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
RecruitingPhase 1
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor
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
5 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 EPO906 epothilone B in people with Carcinoid and Neuroendocrine Tumors, run by Novartis Pharmaceuticals at 5 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 6 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: every 12 weeks). 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 1 Mar 2017.