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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

NCT ID

Therapeutic Area

AstraZeneca Clinical Trial Information – Outside US

Cancer Study Locator (US and Canada Only)

Research Site

An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMATM) versus Placebo in Subjects with Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer

Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.

The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.  
The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE.

Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation.  Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >=  12 weeks

Response is defined as a confirmed best objective response of CR or PR.  Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment). Values are estimated as the medians weren't met

As data was immature at data cut off, number of death events is quoted

Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR  being defined according to level of CTN.

Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR  being defined  according to level of CEA.

TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain.

Arms	Assigned Interventions
No Intervention: 1 Placebo vandetanib	-
Experimental: 2 Vandetanib	Drug: ZD6474 (Vandetanib) once daily oral tablet Other Name: ZACTIMA™

An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

AstraZeneca Clinical Trial Information – Outside US

Cancer Study Locator (US and Canada Only)

CSR-D4200C00058.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator