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A Randomized Discontinuation Study of XL184 in Subjects With Advanced Solid Tumors


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors, Cancer

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Trial Information

A Randomized Discontinuation Study of XL184 in Subjects With Advanced Solid Tumors


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of XL184 in subjects with advanced solid tumors

Outcome Time Frame:

Assessed approximately every 6 weeks using MRI, CT, and/or bone scans

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

XL184-203

NCT ID:

NCT00940225

Start Date:

August 2009

Completion Date:

December 2012

Related Keywords:

  • Solid Tumors
  • Cancer
  • Breast Cancer
  • Melanoma
  • Stomach or Gastroesophageal Junction Carcinoma
  • Hepatocellular Carcinoma (HCC)
  • Small Cell Lung Cancer (SCLC)
  • Non-Small Cell Lung Cancer (NSCLC)
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Stanford University Medical CenterStanford, California  94305-5408
University of California Davis Cancer CenterSacramento, California  95817
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Florida Cancer SpecialistsFort Myers, Florida  33901
University of OklahomaOklahoma City, Oklahoma  73190
Rocky Mountain Cancer CentersThornton, Colorado  80260
Medical College of GeorgiaAugusta, Georgia  30912
University of WashingtonSeattle, Washington  98195
Mary Crowley Medical Research CenterDallas, Texas  75246
Tyler Cancer CenterTyler, Texas  75702
University of California, San FranciscoSan Francisco, California  94143
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Duke University Medical CenterDurham, North Carolina  27710
Cancer Care AssociatesTulsa, Oklahoma  74136
Wayne State UniversityDetroit, Michigan  48202
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Tulane University Health Sciences CenterNew Orleans, Louisiana  70112
Yale University School Of MedicineNew Haven, Connecticut  06520
Kansas City Cancer CenterKansas City, Missouri  64111
Sarah Cannon Research InstituteNashville, Tennessee  37203
NYU Clinical Cancer CenterNew York, New York  10016
Texas Oncology - Central Austin Cancer CenterAustin, Texas  78731
University of Michigan Health SystemAnn Arbor, Michigan  
Northwest Cancer SpecialistsPortland, Oregon  97225
Dana Farber Cancer CenterBoston, Massachusetts  02115
Fairfax Northern Virginia Hematology OncologyFairfax, Virginia  
Pinnacle Oncology of ArizonaScottsdale, Arizona  85258
University of Missouri Health CareColumbia, Missouri  65203
Midwest Hematology Oncology ConsultantsSt. Louis, Missouri  63136
Ohio State University GYN OncologyHilliard, Ohio  43026
Cancer Centers of the Carolinas, ITORGreenville, South Carolina  29605
University of Texas, M. D., Anderson Cancer CenterHouston, Texas  77030