Study of Cabozantinib (XL184) in Adults With Advanced Malignancies

Completed · Phase 2 · Has a placebo group

Conditions studied: Solid Tumors, Cancer

In brief

This is a Phase 2 study to evaluate the efficacy and safety of cabozantinib (XL184) in subjects with selected advanced tumor types.

Key facts

Study ID

NCT00940225

Run by

Exelixis

People needed

730

Starts

2009-09-01

Expected to finish

2014-06-01

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pinnacle Oncology of Arizona — Scottsdale, Arizona, United States
• University of California Davis Cancer Center — Sacramento, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Central Indiana Cancer Centers — Indianapolis, Indiana, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Dana Farber Cancer Center — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• University of Missouri Health Care — Columbia, Missouri, United States
• Kansas City Cancer Center — Lee's Summit, Missouri, United States
• Midwest Hematology Oncology Consultants — St Louis, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• NYU Clinical Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Ohio State University GYN Oncology — Hilliard, Ohio, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Cancer Care Associates — Tulsa, Oklahoma, United States
• Northwest Cancer Specialists — Tualatin, Oregon, United States

Full record on ClinicalTrials.gov

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