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Status:

COMPLETED

Study of Cabozantinib (XL184) in Adults With Advanced Malignancies

Lead Sponsor:

Exelixis

Conditions:

Solid Tumors

Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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

Detailed Description

The goal of this clinical trial was to learn about the efficacy, safety, and tolerability of cabozantinib against a placebo in subjects with Metastatic Breast Cancer (MBC), Gastric and Gastroesophagea...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2014

Estimated Enrollment :

730 Patients enrolled

Trial Details

Trial ID

NCT00940225

Start Date

September 1 2009

End Date

June 1 2014

Last Update

April 25 2024

Active Locations (47)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 12 (47 locations)

1

Pinnacle Oncology of Arizona

Scottsdale, Arizona, United States, 85258

2

University of California Davis Cancer Center

Sacramento, California, United States, 95817

3

University of California, San Francisco

San Francisco, California, United States, 94115

4

Stanford University Medical Center

Stanford, California, United States, 94305