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EPO906 in Carcinoid and Other Neuroendocrine Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00050349
First received: December 4, 2002
Last updated: March 7, 2013
Last verified: March 2013

December 4, 2002
March 7, 2013
July 2002
April 2007   (final data collection date for 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00050349 on ClinicalTrials.gov Archive Site
  • Time to progression [ Time Frame: until documented disease progression, death or date of follow up ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: after treatment, every 3 months (maximum of 12 months) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
EPO906 in Carcinoid and Other Neuroendocrine Tumors
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoid
  • Neuroendocrine Tumors
Drug: EPO906 epothilone B
Other Name: patupilone
Experimental: EPO906
Intervention: Drug: EPO906 epothilone B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
April 2007
April 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00050349
CEPO906A2212
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP