An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

Phase 3

Completed

• Conditions: Thyroid Cancer
• Interventions: Drug: ZD6474 (Vandetanib)

• Registration Number: NCT00410761
• Lead Sponsor: Genzyme, a Sanofi Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-30
• Study First Submitted: 2006-12-06
• Study First Submitted QC: 2006-12-12
• Study First Posted: 2006-12-13
• Primary Completion: 2009-07-31
• Disposition First Submitted: 2011-03-28
• Disposition First Submitted QC: 2011-03-28
• Disposition First Posted: 2011-04-06
• Results First Submitted: 2011-04-27
• Results First Submitted QC: 2012-02-22
• Results First Posted: 2012-03-26
• Study Completion: 2024-07-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 437

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ZD6474 (Vandetanib)	Vandetanib

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival(PFS)	RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Number of deaths since randomisation	As data was immature at data cut off, number of death events is quoted
Biochemical Response Calcitonin (CTN)	Blood samples Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up	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.
Objective Response Rate (ORR)	RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.	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.
Biochemical Response Carcinoembryonic Antigen (CEA)	Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up	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.
Disease Control Rate (DCR)	RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent	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
Duration of Response (DoR)	RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent	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
Time to Worsening of Pain (TWP)	During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.	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.

Trial Locations

Locations (127)

University Arkansas Site Number : 3; 🇺🇸 Little Rock, Arkansas, United States

USCF / Mt Zion Medical Center Site Number : 8; 🇺🇸 San Francisco, California, United States

University Of Colorado Health Sciences Center Site Number : 9; 🇺🇸 Aurora, Colorado, United States

Yale University School Medicine Site Number : 11; 🇺🇸 New Haven, Connecticut, United States

Mayo Clinic- Site Number : 15; 🇺🇸 Jacksonville, Florida, United States

The University Of Chicago Site Number : 18; 🇺🇸 Chicago, Illinois, United States

The University Of Kentucky Site Number : 17; 🇺🇸 Lexington, Kentucky, United States

Dana Farber Cancer Institute Site Number : 2; 🇺🇸 Boston, Massachusetts, United States

Wayne State University / Harper Hospital Site Number : 7; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic- Site Number : 14; 🇺🇸 Rochester, Minnesota, United States

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