Efficacy Study of XL184 in Adults With Medullary Thyroid Cancer
Verified by Exelixis, January 2012
First Received: June 23, 2008 Last Updated: April 6, 2010 History of Changes
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Sponsored by::
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Exelixis |
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Information provided by:
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Exelixis |
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ClinicalTrials.gov Identifier:
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NCT00704730 |
Purpose
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.
Site/location information will be updated periodically.
| Condition | Intervention | Phase |
|---|---|---|
| Thyroid Cancer | Drug: XL184 Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Drug Information available for: Thyroid
Further study details as provided by Exelixis:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 315 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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| 1: Experimental | Drug: XL184
Gelatin capsules supplied in 25-mg and 100-mg strengths administered orally daily
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| 2: Placebo Comparator | Drug: Placebo
Gelatin capsules color and size-matched to XL184 capsules administered orally daily
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 or less.
- 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 birth control 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 or more years previously) and currently has no evidence of cancer (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% or more 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 or more weeks prior to randomization and stable without steroid and without anti-convulsant treatment for 10 or more days.
- The subject has a history of clinically significant episodes of vomiting blood or a recent history of vomiting more than 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704730
Contacts
Contact: Exelixis Contact Line 1-866-939-4041
Show 101 Study Locations
Sponsors and Collaborators
Exelixis
More Information
No publications provided
| Responsible Party: | Exelixis (Ron Weitzman, MD/Vice President, Clinical Research) |
| Study ID Numbers: | XL184-301 |
| Study First Received: | June 23, 2008 |
| Last Updated: | April 6, 2010 |
| ClinicalTrials.gov Identifier: | NCT00704730 History of Changes |
| Health Authority: | United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Denmark: Danish Medicines Agency; Netherlands: Medicines Evaluation Board (MEB); Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines; Canada: Health Canada; Israel: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Poland: Ministry of Health; Austria: Agency for Health and Food Safety; Italy: The Italian Medicines Agency; Greece: National Organization of Medicines; India: Drugs Controller General of India; Portugal: National Pharmacy and Medicines Institute; South Korea: Korea Food and Drug Administration (KFDA); Russia: Ministry of Health and Social Development of the Russian Federation; Chile: Comisión Nacional de Investigación Científica y Tecnológica; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Brazil: Ministry of Health; Switzerland: Swissmedic; Saudi Arabia: Ethics Committee |
Keywords provided by Exelixis:
Medullary Thyroid Cancer
MTC
Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Thyroid Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Endocrine Gland Neoplasms
ClinicalTrials.gov process this record on April 29, 2010
The information on this study is the same as contained on ClinicalTrials.gov
