Study of Cabozantinib (XL184) in Adults With Advanced Malignancies
Trial ID or NCT#
Status
Purpose
This is a Phase 2 study to evaluate the efficacy and safety of cabozantinib (XL184) in subjects with selected advanced tumor types.
Official Title
A Randomized Discontinuation Study of XL184 in Subjects With Advanced Solid Tumors
Eligibility 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
- - 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 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 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 a corrected QT interval(QTcF)>500 ms at screening - 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
Investigator(s)
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Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov