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Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Cylene Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00780663
First received: October 27, 2008
Last updated: June 13, 2011
Last verified: June 2011

October 27, 2008
June 13, 2011
October 2008
March 2010   (final data collection date for primary outcome measure)
Clinical benefit. Clinical benefit is defined as a reduction of secretory symptoms or reduction of quantifiable hormones or other biochemical tumor markers where concomitantly there is an absence of radiological evidence for tumor progression. [ Time Frame: monthly for clinical benefit, every two months for tumor progression ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00780663 on ClinicalTrials.gov Archive Site
Evaluate response rate, duration of response and progression free survival per RECIST criteria and the plasma and whole blood levels of quarfloxin. [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma
A Phase 2, Multi-Center, Open Label Study Evaluating the Efficacy and Safety of Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

This is a Phase 2, open-label, multicenter, efficacy and safety study of quarfloxin in patients with low or intermediate grade neuroendocrine cancer. The purpose of this study is to evaluate the rate of clinical benefit response to quarfloxin treatment including the reduction in secretory symptoms of flushing and/or diarrhea or the reduction quantifiable hormones or other biochemical tumor markers.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neuroendocrine Tumors
  • Carcinoid Tumor
Drug: Quarfloxin
IV Quarfloxin 240 mg/m2 daily x5 days every 21 days
Other Names:
  • CX-3543
  • quarfloxin
Experimental: Quarfloxin
Single arm study - open label.
Intervention: Drug: Quarfloxin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed low or intermediate grade neuroendocrine carcinoma including carcinoid and islet cell cancer. Patients with neuroendocrine tumors associated with MEN1 syndrome are eligible.
  • Measureable disease by RECIST
  • Unresectable or metastatic disease
  • Secretory symptoms of diarrhea or flushing or both attributed to their carcinoid tumor and/or quantifiable hormones or other biochemical markers
  • Males and females 18 years of age or older.
  • Zero to two prior cytotoxic chemotherapy regimens.
  • Patients may be receiving concomitant octreotide Sandostatin®
  • Patients must have central IV access, or agree to the insertion of a central IV line.
  • All previous cancer therapies, radiation, and surgery, must have been discontinued at least 21 days prior to the start of treatment.
  • Acceptable liver function
  • Acceptable renal function
  • Acceptable hematologic status
  • ECOG Performance Status ≤1.
  • Anticipated survival of at least 6 months.
  • Able to maintain a patient diary.
  • For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment.
  • Ability to understand the requirements of the study, provide written informed consent and agree to abide by the study restrictions and return to the clinic for required assessments.

Exclusion Criteria:

  • Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid or small cell carcinoma.
  • Pregnant or nursing women.
  • Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
  • Seizures not controlled by anticonvulsant therapy.
  • Participation in any investigational drug study within 28 days before quarfloxin administration or currently receiving investigational therapy.
  • Patients with a second malignancy requiring active treatment.
  • Active symptomatic bacterial, fungal, or viral infection including active HIV or viral hepatitis.
  • Prior treatment with quarfloxin.
  • Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
  • Patients who have exhibited allergic reactions to a similar structural compound or formulation.
  • Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00780663
C3-07-003
No
Claire Padgett, VP Clinical Operations, Cylene Pharmaceuticals Inc.
Cylene Pharmaceuticals
Not Provided
Not Provided
Cylene Pharmaceuticals
June 2011

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