Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

Brief Title

Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

Official Title

A Phase 2, Multi-Center, Open Label Study Evaluating the Efficacy and Safety of Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

Brief Summary

      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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

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.

Secondary Outcome

 Evaluate response rate, duration of response and progression free survival per RECIST criteria and the plasma and whole blood levels of quarfloxin.

Condition

Neuroendocrine Tumors

Intervention

Quarfloxin

Study Arms / Comparison Groups

 Quarfloxin

Description:  Single arm study - open label.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

25

Start Date

October 2008

Completion Date

March 2010

Primary Completion Date

March 2010

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

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Location Countries

United States

Location Countries

United States

NCT ID

NCT00780663

Organization ID

C3-07-003

Study Sponsor

Cylene Pharmaceuticals

Study Sponsor

, , 

Verification Date

June 2011