Study of Cabozantinib (XL184) in Adults With Advanced Malignancies

Inclusion Criteria:

The subject has a cytologically or histologically and radiologically confirmed, advanced, recurrent, or metastatic solid tumor of the nine types listed below:

Pancreatic Cancer
Castration-Resistant Prostate Cancer (CRPC)
Hepatocellular Carcinoma (HCC)
Gastric or Gastroesophageal Junction Cancer
Melanoma
Small Cell Lung Cancer (SCLC)
Ovarian cancer, primary peritoneal or fallopian tube carcinoma
Breast cancer that is one of the following subtypes: estrogen receptor positive breast cancer, estrogen receptor/progesterone receptor/HER2-negative (triple-negative), or inflammatory (regardless of receptor status) disease histology
Non-Small Cell Lung Cancer (NSCLC)
Certain requirements for prior therapies may apply
The subject has documented progressive disease at screening
Subjects having any tumor type of other than CRPC must have at least one lesion that is not within a previously irradiated field and is measurable on CT or MRI scan
The subject has recovered to baseline or CTCAE ≤ Grade 1 from toxicities related to prior treatment (some exceptions apply)
The subject is ≥ 18 years old on the day of consent
Tissue samples from archival or fresh tissue, or a tissue block of the subject's tumor
The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
The subject has adequate organ function
The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document
Sexually active fertile subjects (male and female), and their partners, must agree to use medically accepted methods of contraception during the course of the study and for 3 months after the last dose of the study drug(s)
Female subjects of childbearing potential must have a negative pregnancy test at screening

Exclusion Criteria:

The subject has experienced clinically-significant hematemesis or hemoptysis of >0.5 teaspoon of red blood, or other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
The subject has a cavitating pulmonary lesion(s) or a pulmonary lesion abutting or encasing a major blood vessel
Certain restrictions on prior treatments apply
The subject has received drugs used to control loss of bone mass within 4 weeks prior to the first dose of study treatment
The subject has known symptomatic or uncontrolled brain metastases or epidural disease
The subject has prothrombin time/International Normalized Ratio (PT/INR) or partial thromboplastin time (PTT) test results that are above (1.3x)the laboratory upper limit of normal
The subject has a corrected QT interval(QTcF)>500 ms at screening
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or Coumadin-related agents, heparin, thrombin or FXa inhibitors, and antiplatelet agents (low-dose aspirin (≤81 mg/day), low-dose warfarin (≤1mg/day, and prophylactic low molecular weight heparin (LMWH) are permitted)
The subject has uncontrolled, significant intercurrent illness
The subject is unable to swallow capsules
The subject is pregnant or breastfeeding
The subject has a previously-identified allergy or hypersensitivity to components of the study treatment formulation
The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
The subject has had another diagnosis of malignancy requiring systemic treatment within the last two years, unless non-melanoma skin cancer, in-situ carcinoma of the cervix, or superficial bladder cancer