Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib (CELESTIAL)

April 8, 2021 updated by: Exelixis

A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib

The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

707

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Concord, New South Wales, Australia, 2139
      • Darlinghurst, New South Wales, Australia, 2010
      • Kogarah, New South Wales, Australia, 2217
      • Westmead, New South Wales, Australia, 2145
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
    • Victoria
      • Melbourne, Victoria, Australia, 3050
    • Western Australia
      • Perth, Western Australia, Australia, 6000
  • Belgium
      • Liege, Belgium, 4000
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
    • Hainaut
      • La Louvière, Hainaut, Belgium, 7100
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
  • France
      • Besançon, France, 25000
      • Bordeaux, France, 33075
      • Clermont-Ferrand, France, 63003
      • Lille, France, 59037
      • Lyon, France, 69317
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 6202
    • Somme
      • Amiens, Somme, France, 80054
    • Val-de-Marne
      • Creteil, Val-de-Marne, France, 94010
  • Germany
      • Berlin, Germany, 13353
      • Freiburg, Germany
    • Baden-Württemberg
      • Esslingen am Neckar, Baden-Württemberg, Germany, 73730
      • Tübingen, Baden-Württemberg, Germany, 72076
    • Bayern
      • München, Bayern, Germany, 81675
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
  • Hong Kong
      • Hong Kong, Hong Kong
  • Ireland
      • Dublin, Ireland, 7
  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
      • Faenza, Emilia-Romagna, Italy, 48018
      • Meldola, Emilia-Romagna, Italy, 47014
      • Rimini, Emilia-Romagna, Italy, 47900
    • Lazio
      • Roma, Lazio, Italy, 128
      • Roma, Lazio, Italy, 168
    • Liguria
      • Genova, Liguria, Italy, 16132
    • Lombardia
      • Milan, Lombardia, Italy, 20122
      • Rozzano, Lombardia, Italy, 20089
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
    • Veneto
      • Padova, Veneto, Italy, 35128
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
      • Seongnam, Korea, Republic of, 463-707
      • Seoul, Korea, Republic of, 137-701
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 135-710
      • Seoul, Korea, Republic of, 136-705
      • Suwon-si, Korea, Republic of, 443-721
    • Gyeonggido
      • Goyang, Gyeonggido, Korea, Republic of, 410-769
  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333 ZA
  • New Zealand
    • North Island
      • Auckland, North Island, New Zealand, 1003
  • Poland
      • Myslowice, Poland, 41-400
      • Poznan, Poland, 60-569
    • Warminsko-Mazurskie
      • Olsztyn, Warminsko-Mazurskie, Poland, 10-513
  • Romania
      • Brasov, Romania, 500019
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
  • Singapore
      • Singapore, Singapore, 119074
      • Singapore, Singapore, 308433
      • Singapore, Singapore, 169610
  • Spain
      • Madrid, Spain, 28041
      • Madrid, Spain, 28007
      • Zaragoza, Spain, 50009
    • Alicante
      • Elche, Alicante, Spain, 3293
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
      • Torrejon de Ardoz, Madrid, Spain, 28850
  • Taiwan
      • Taichung, Taiwan, 40705
      • Taipei, Taiwan, 100
    • Tainan
      • Liuying Township, Tainan, Taiwan, 736
  • Turkey
      • Edirne, Turkey, 22030
      • Gaziantep, Turkey, 27100
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
      • London, United Kingdom, SE5 9RS
      • London, United Kingdom, NW3 2QG
      • Manchester, United Kingdom, M20 4BX
    • England
      • Wirral, England, United Kingdom, CH63 4JY
  • United States
    • California
      • Corona, California, United States, 92879
      • Los Angeles, California, United States, 90033
      • San Diego, California, United States, 92123
      • San Francisco, California, United States, 94115
    • Florida
      • Gainesville, Florida, United States, 32610
    • Georgia
      • Atlanta, Georgia, United States, 30318
    • Hawaii
      • Honolulu, Hawaii, United States, 96815
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • Kansas City, Missouri, United States, 64128
      • Saint Louis, Missouri, United States, 63110
    • Nevada
      • Las Vegas, Nevada, United States, 89109
    • New Jersey
      • East Orange, New Jersey, United States, 07018
    • New York
      • New York, New York, United States, 10032
      • New York, New York, United States, 10065
      • Valhalla, New York, United States, 10595
    • Texas
      • Dallas, Texas, United States, 75246
      • San Antonio, Texas, United States, 78215
    • Washington
      • Seattle, Washington, United States, 98104
      • Seattle, Washington, United States, 98109
      • Spokane, Washington, United States, 99208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Select Inclusion Criteria:

  1. Histological or cytological diagnosis of HCC.
  2. The subject has disease that is not amenable to a curative treatment approach.
  3. Received prior sorafenib.
  4. Progression following at least 1 prior systemic treatment for HCC.
  5. Recovery to from toxicities related to any prior treatments.
  6. ECOG performance status of 0 or 1.
  7. Adequate hematologic and renal function, based upon meeting protocol defined laboratory criteria within 7 days before randomization.
  8. Child-Pugh Score of A.
  9. Antiviral therapy per local standard of care if active hepatitis B (HBV) infection.
  10. Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
  11. Female subjects of childbearing potential must not be pregnant at screening.

Select Exclusion Criteria:

  1. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
  2. Receipt of more than 2 prior systemic therapies for advanced HCC.
  3. Any type of anticancer agent (including investigational) within 2 weeks before randomization.
  4. Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment within 6 weeks of randomization.
  5. Prior cabozantinib treatment.
  6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
  7. Concomitant anticoagulation, at therapeutic doses, with anticoagulants.
  8. Serious illness other than cancer that would preclude safe participation in the study.
  9. Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding.
  10. Moderate or severe ascites.
  11. Pregnant or lactating females.
  12. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low-grade tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cabozantinib (XL184)
Cabozantinib (XL184) 60 mg tablet once daily
Drug: Cabozantinib tablets
Other Names:
  • XL184
Placebo Comparator: Placebo
Oral cabozantinib-matched placebo tablet once daily
Drug: Placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 45 months
The primary analysis of OS is defined as the time from randomization to death from any cause. The analysis was based on a second planned interim analysis prespecified to be performed at approximately the 75% information fraction (ie, at approximately 466 deaths). The data cutoff date for this event-driven analysis in the Intent to Treat (ITT) population was 01 June 2017. Median OS was calculated using the Kaplan-Meier estimates.
Up to 45 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to 45 months
Duration of PFS is defined as the time of randomization to the earlier of the following events, progressive disease as determined by Investigator (per RECIST 1.0, which is defined by a ≥ 20% increase in the sum of the longest diameter of target lesions from baseline) or death due to any cause. A Kaplan- Meier analysis was performed to estimate the median duration.
Up to 45 months
Objective Response Rate (ORR)
Time Frame: ORR is measured by radiologic assessment every 8 weeks after randomization until disease progression or discontinuation of study treatment (up to 45 months)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
ORR is measured by radiologic assessment every 8 weeks after randomization until disease progression or discontinuation of study treatment (up to 45 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exelixis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 26, 2013

Primary Completion (Actual)

October 16, 2017

Study Completion (Actual)

January 12, 2021

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 24, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL184-309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Placebo tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe