An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
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ClinicalTrials.gov Identifier: NCT00410761 |
Recruitment Status :
Active, not recruiting
First Posted : December 13, 2006
Results First Posted : March 26, 2012
Last Update Posted : October 2, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thyroid Cancer | Drug: ZD6474 (Vandetanib) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 437 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | November 30, 2006 |
Actual Primary Completion Date : | July 31, 2009 |
Estimated Study Completion Date : | June 28, 2024 |
Arm | Intervention/treatment |
---|---|
No Intervention: 1
Placebo vandetanib
|
|
Experimental: 2
Vandetanib
|
Drug: ZD6474 (Vandetanib)
once daily oral tablet
Other Names:
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- Progression-Free Survival(PFS) [ Time Frame: 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then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.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.
- Objective Response Rate (ORR) [ Time Frame: 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.
- Disease Control Rate (DCR) [ Time Frame: 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) [ Time Frame: 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
- Overall Survival (OS) [ Time Frame: Number of deaths since randomisation ]As data was immature at data cut off, number of death events is quoted
- Biochemical Response Calcitonin (CTN) [ Time Frame: 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.
- Biochemical Response Carcinoembryonic Antigen (CEA) [ Time Frame: 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.
- Time to Worsening of Pain (TWP) [ Time Frame: 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410761
Study Director: | Clinical Sciences & Operations | Sanofi |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Genzyme, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00410761 |
Other Study ID Numbers: |
D4200C00058 2005-005077-29 ( EudraCT Number ) LPS14811 ( Other Identifier: Sanofi ) |
First Posted: | December 13, 2006 Key Record Dates |
Results First Posted: | March 26, 2012 |
Last Update Posted: | October 2, 2023 |
Last Verified: | September 2023 |
ZD6474 MTC Hereditary Medullary Thyroid Cancer Sporadic Medullary Thyroid Cancer Medullary Thyroid Cancer |
Thyroid Neoplasms Carcinoma, Neuroendocrine Thyroid Diseases Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |