Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00005513

Trial Description

start of 1:1-Block title

Title

An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 Versus Placebo in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

EXAM

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005513
  •   2014/01/16
  •   2008/06/23
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT00704730  (ClinicalTrials.gov)
  •   XL184-301  (Exelixis)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Thyroid Cancer
  •   C73 -  Malignant neoplasm of thyroid gland
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: XL184
  •   Drug: Placebo
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- 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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- To evaluate overall survival (OS) with XL184 as compared with placebo; time frame: Assessed as applicable
- 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
- To evaluate the safety and tolerability of XL184; time frame: Assessed at periodic visits
- To assess the pharmacokinetics and pharmacodynamic effects of XL184; time frame: Assessed at periodic visits

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   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
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2008/06/30
  •   315
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Exelixis
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.