Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer (EXAM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Exelixis.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT00704730
First received: June 23, 2008
Last updated: May 24, 2012
Last verified: May 2012

June 23, 2008
May 24, 2012
June 2008
October 2011   (final data collection date for primary outcome measure)
To evaluate progression-free survival (PFS) with XL184 as compared with placebo in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC) [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
To evaluate progression-free survival (PFS) with XL184 treatment as compared with placebo in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC) [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00704730 on ClinicalTrials.gov Archive Site
  • To evaluate overall survival (OS) with XL184 as compared with placebo [ Time Frame: Assessed as applicable ] [ Designated as safety issue: No ]
  • To evaluate the objective response rate (ORR) and duration of response in subjects with measurable disease with XL184 as compared with placebo [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of XL184 [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: Yes ]
  • To assess the pharmacokinetics and pharmacodynamic effects of XL184 [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
  • To evaluate overall survival (OS) with XL184 treatment as compared with placebo [ Time Frame: Assessed as applicable ] [ Designated as safety issue: No ]
  • To evaluate the objective response rate (ORR) and duration of response in subjects with measurable disease with XL184 treatment as compared with placebo [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of XL184 treatment [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: Yes ]
  • To assess the pharmacokinetics and pharmacodynamic effects of XL184 treatment [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer
An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 Versus Placebo in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration.

The Clinical Steering Committee for this study, comprised of study doctors who specialize in medullary thyroid cancer, has provided guidance regarding the design of the study. The committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven Sherman, MD.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Thyroid Cancer
  • Drug: XL184
    Gelatin capsules supplied in 25-mg and 100-mg strengths administered orally daily
  • Drug: Placebo
    Gelatin capsules color and size-matched to XL184 capsules administered orally daily
  • Experimental: 1
    Intervention: Drug: XL184
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Elisei R, Schlumberger MJ, Müller SP, Schöffski P, Brose MS, Shah MH, Licitra L, Jarzab B, Medvedev V, Kreissl MC, Niederle B, Cohen EE, Wirth LJ, Ali H, Hessel C, Yaron Y, Ball D, Nelkin B, Sherman SI. Cabozantinib in progressive medullary thyroid cancer. J Clin Oncol. 2013 Oct 10;31(29):3639-46. doi: 10.1200/JCO.2012.48.4659. Epub 2013 Sep 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
315
March 2013
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subject has a histologically confirmed diagnosis of MTC that is cannot be removed by surgery, is locally advanced, or has spread in the body.
  • The subject is at least 18 years old.
  • The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
  • The subject has documented worsening of disease (progressive disease) at screening compared with a previous CT scan or MRI image done within 14 months of screening.
  • The subject has recovered from clinically significant adverse events (side effects) due to any other medications that were administered prior to randomization.
  • The subject has adequate organ and bone marrow function.
  • Subjects who are sexually active (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 3 months following discontinuation of study treatments.
  • The subject has no other diagnosis of cancer (unless non-melanoma skin cancer, an early form of cervical cancer, or another cancer diagnosed ≥ 2 years previously) and currently has no evidence of malignancy (unless non-melanoma skin cancer or an early form of cervical cancer).
  • Female subjects of childbearing potential must have a negative pregnancy test at screening.

Exclusion Criteria:

  • The subject has received prior treatment for their cancer within 4 weeks of randomization (6 weeks for nitrosoureas or mitomycin C).
  • The subject has received radiation to ≥ 25 % of bone marrow.
  • The subject has received treatment with other investigational agents (unapproved therapies) within 4 weeks of randomization.
  • The subject has received treatment with XL184.
  • The subject has brain metastases or spinal cord compression, unless completed radiation therapy ≥ 4 weeks prior to randomization and stable without steroid and without anti-convulsant treatment for ≥ 10 days.
  • The subject has a history of clinically significant episodes of vomiting blood or a recent history of vomiting > 2.5 mL (about 1/2 teaspoon) of red blood
  • The subject has serious illness other than cancer
  • The subject is pregnant or breastfeeding.
  • The subject has an active infection requiring ongoing treatment.
  • The subject is incapable of understanding and complying with the protocol or unable to provide informed consent.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Denmark,   France,   Germany,   Greece,   India,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Peru,   Poland,   Portugal,   Russian Federation,   Saudi Arabia,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT00704730
XL184-301
Yes
Exelixis
Exelixis
Not Provided
Not Provided
Exelixis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP