Study of Cabozantinib (XL184) in Adults With Advanced Malignancies
This is a Phase 2 study to evaluate the efficacy and safety of cabozantinib (XL184) in subjects with selected advanced tumor types.
Checked against the public recordLast updated Apr 25, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Exelixis
- Interventions being studied
- Drug: Cabozantinib; Drug: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Pinnacle Oncology of ArizonaScottsdale, Arizona
- University of California Davis Cancer CenterSacramento, California
- University of California, San FranciscoSan Francisco, California
- Stanford University Medical CenterStanford, California
- Rocky Mountain Cancer CentersDenver, Colorado
- Yale University School of MedicineNew Haven, Connecticut
- Florida Cancer SpecialistsFort Myers, Florida
- Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida
- Medical College of GeorgiaAugusta, Georgia
- Central Indiana Cancer CentersIndianapolis, Indiana
- Tulane University Health Sciences CenterNew Orleans, Louisiana
- Dana Farber Cancer CenterBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 25, 2024. Always confirm current availability with the study team.