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

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.