Phase 3
Completed N=331
An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
Source: ClinicalTrials.gov NCT00410761 ↗Enrolled (actual)
331
Serious AEs
38.0%
Results posted
Mar 2012
Primary outcomePrimary: Progression-Free Survival(PFS) — 30.5; 19.2 Months
Summary
The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival(PFS) |
30.5; 19.2 | — |
| SECONDARY Objective Response Rate (ORR) |
104; 13 | — |
| SECONDARY Disease Control Rate (DCR) |
200; 71 | — |
| SECONDARY Duration of Response (DoR) |
22.2; 16.3 | — |
| SECONDARY Overall Survival (OS) |
81.6; 80.4 | — |
| SECONDARY Biochemical Response Calcitonin (CTN) |
160; 3 | — |
| SECONDARY Biochemical Response Carcinoembryonic Antigen (CEA) |
119; 2 | — |
| SECONDARY Time to Worsening of Pain (TWP) |
7.85; 3.25 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic Medullary Thyroid Cancer.
- Presence of measurable tumor
- Able to swallow medication
Exclusion Criteria
- Major surgery within 4 weeks before randomization
- Last dose of prior chemotherapy received less than 4 weeks prior to randomization
- Radiation therapy within the last 4 weeks prior to randomization(with exception of palliative radiotherapy)
- Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
- Significant cardiac events
- Previous ZD6474 treatment
Data sourced from ClinicalTrials.gov (NCT00410761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.