An Open-Label, Fixed-Dose, Clinical Study of Quinacrine Safety and Efficacy in the Treatment of Advanced Renal Cell Carcinoma

Inclusion Criteria:

- Confirmed RCC with clear cell predominance.

- Subjects must provide written informed .

- Subjects must be at least 18 years old.

- Subjects must have at least 1 measurable lesion.

- Subjects must have metastatic, locally advanced or unresectable RCC.

- Subjects must have received ≥ 1 prior systemic regimen for RCC.

- All prior cancer therapy, including radiation, surgery, and systemic (hormonal,
chemotherapeutic, and immunotherapeutic) therapy, must be completed at least 4 weeks
before the baseline visit.

- Subjects must be capable of adhering to the study visit schedule and other protocol
requirements.

- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0 to 2.

- Subjects must have:

1. Absolute neutrophil count (ANC)> 1,500/uL

2. Hemoglobin > 10.0 g/dL

3. Platelets ≥ 100,000/uL

4. Serum creatinine < 2.0 mg/dL

- Subjects must have adequate hepatic function, as defined by a bilirubin level of ≤
1.5 times the upper limit of the normal range (ULN) and an aspartate aminotransferase
(AST) or alanine aminotransferase (ALT) level of ≤ 3 times the ULN (or ≤ 5 times the
ULN if liver metastases are present).

- Women of childbearing potential must have a negative serum pregnancy test at the
screening visit and throughout the study.

- Sexually active women and men must agree to use a medically acceptable form of
contraception.

Exclusion Criteria:

- Subjects who have a history of any malignancy (other than excised basal cell
carcinoma or cervical intraepithelial neoplasia) within the 5 years of baseline
visit.

- Subjects who have received any anticancer agents, treatment (chemotherapy, targeted
agents, radiation, hormones), or investigational agents within 30 days of the
baseline visit.

- Subjects who have untreated brain metastases.

- Subjects who have a history of hypersensitivity reaction to quinacrine or other
acridine derivatives (e.g. Cognex).

- Subjects who have any clinically significant hematological, endocrine, cardiovascular
(including any rhythm disorder), renal, hepatic, gastrointestinal (GI), or
neurological disease (including any history of seizure).

- Subjects who have a history of porphyria or psoriasis.

- Subjects who have documented glucose-6-phosphate dehydrogenase deficiency.

- Subjects who have a history of noninfectious (toxic, autoimmune) hepatitis.

- Subjects who have a history of schizophrenia, bipolar disorder, or any psychiatric
illness/social situations that would limit compliance with study requirements.

- Subjects who have a history of dermatitis as an allergic/toxic reaction to any
medication.

- Subjects who have any grade 2 sensory neuropathy.

- Subjects who have a QTcF (Fredericia) of > 450 msec.

- Subjects who have New York Heart Association (NYHA) class 3 or 4 heart failure.

- Subjects who had a myocardial infarction or acute coronary syndrome within 6 months
of the baseline visit.

- Subjects who require anti-arrhythmic treatment with amiodarone or any drug with a
quinidine-like effect on the heart or who have history of a malignant ventricular
arrhythmia unless they have a functioning Automatic Implantable Cardio-Defibrillator
(AICD) implanted.

- Subjects who are immunocompromised, including those known to be human
immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive.