EPO906 in Carcinoid and Other Neuroendocrine Tumors

• ClinicalTrials.gov Identifier: NCT00050349
• Recruitment Status: Completed
• First Posted: December 5, 2002
• Last Update Posted: March 1, 2017
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: December 4, 2002
• First Posted Date: December 5, 2002
• Last Update Posted Date: March 1, 2017
• Study Start Date: July 2002
• Actual Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 26, 2010): 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 ]
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: August 26, 2010)

• 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) ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: EPO906 in Carcinoid and Other Neuroendocrine Tumors
• Official Title: EPO906 Therapy in Patients With Metastatic Carcinoid Tumors and Other Neuroendocrine Tumors
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Carcinoid
• Neuroendocrine Tumors

Intervention

Drug: EPO906 epothilone B

Other Name: patupilone

Study Arms

Experimental: EPO906

Intervention: Drug: EPO906 epothilone B

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 7, 2013): 33
• Original Enrollment (submitted: June 23, 2005): 48
• Actual Study Completion Date: April 2007
• Actual Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.)

Exclusion Criteria:

• 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
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00050349
• Other Study ID Numbers: CEPO906A2212
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Study Sponsor: Novartis Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: March 2013