Tracking Information
Start Date ICMJE | September 2008 |
---|---|
Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: September 19, 2008) | To estimate the effect of administration of 9 mg/kg Q3W of panitumumab on the area under the curve (AUC) of total plasma cisplatin-derived platinum levels and the average concentration at steady state (Css) of 5-fluorouracil (5-FU) in subjects who are re [ Time Frame: Samples will be collected at cycle 2 and over a 96 hour time period ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00756444 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: September 19, 2008) | To estimate the effect of administration of 9 mg/kg Q3W of panitumumab on the maximum concentration (Cmax) of total plasma cisplatin-derived platinum levels, AUC and Cmax of free plasma cisplatin-derived platinum in subjects who are receiving cisplatin a [ Time Frame: Samples will be collected at cycle 2 and over a 96 hour time period ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Pharmacokinetic Sub-study for Amgen Protocol Number 20050251 Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck |
---|---|
Official Title ICMJE | A Pharmacokinetic Sub-study for Amgen Protocol Number 20050251 Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck |
Brief Summary | Study 20080008 is a PK sub-study to study 20050251[Japan 20050251A]. All subjects at a limited number of selected sites who are participating in study 20050251[Japan 20050251A] will be asked to participate in this sub-study. The subjects who do not consent to participate in this sub-study may still participate in study 20050251[Japan 20050251A]. This study is designed to estimate the effect of panitumumab on the PK of cisplatin and 5-FU in subjects receiving cisplatin and 5-FU with or without panitumumab. To maximize any potential effect of panitumumab on the PK of cisplatin and 5-FU, the collection of PK samples of cisplatin and 5-FU will be taken during cycle 2 of the study, the point at which the PK of panitumumab is expected to be at steady-state after a dose of 9 mg/kg given every 3 weeks. |
Detailed Description | Study Phase: 3 Indication: Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck Primary Objective: To estimate the effect of administration of 9 mg/kg Q3W of panitumumab on the area under the curve (AUC) of total plasma cisplatin-derived platinum levels and the average concentration at steady state (Css) of 5-fluorouracil (5-FU) in subjects who are receiving cisplatin and 5-FU as described in Amgen protocol 20050251[Japan 20050251A]. Secondary Objective(s): To estimate the effect of administration of 9 mg/kg Q3W of panitumumab on the maximum concentration (Cmax) of total plasma cisplatin-derived platinum levels, AUC and Cmax of free plasma cisplatin-derived platinum in subjects who are receiving cisplatin and 5-FU as described in Amgen protocol 20050251[Japan 20050251A]. Hypotheses: This is an estimation sub-study rather than formal hypothesis testing, the following will be estimated:
Study Design: Study 20080008 is a PK sub-study to study 20050251[Japan 20050251A]. All subjects at a limited number of selected sites who are participating in study 20050251[Japan 20050251A] will be asked to participate in this sub-study. The subjects who do not consent to participate in this sub-study may still participate in study 20050251[Japan 20050251A]. This study is designed to estimate the effect of panitumumab on the PK of cisplatin and 5-FU in subjects receiving cisplatin and 5-FU with or without panitumumab. To maximize any potential effect of panitumumab on the PK of cisplatin and 5-FU, the collection of PK samples of cisplatin and 5-FU will be taken during cycle 2 of the study, the point at which the PK of panitumumab is expected to be at steady-state after a dose of 9 mg/kg given every 3 weeks. Primary and Secondary Endpoints: The primary endpoints for this study are the ratio of geometric means (with:without panitumumab) for AUC of total plasma cisplatin-derived platinum and average concentration at steady sate (Css) of 5-FU measured at cycle 2 at which time panitumumab levels are anticipated to be at steady state. Secondary endpoints are the ratio of geometric means (with:without panitumumab) for 1) Cmax of total plasma cisplatin-derived platinum and 2) Cmax and AUC of free plasma cisplatin-derived platinum measured at cycle 2. Sample Size: Approximately 35 subjects from Study 20050251[Japan 20050251A] will participate in Study 20080008. At least fifteen evaluable subjects (defined as providing sufficient PK samples to permit calculation of AUC for total plasma cisplatin-derived platinum and average concentration at steady state for 5-FU in cycle 2) per arm will be required. Additional subjects will be sequentially included until at least fifteen evaluable subjects per arm are achieved. It is therefore estimated that approximately 35 subjects from study 20050251[Japan 20050251A] will need to participate in the sub-study assuming up to 14% of subjects do not provide evaluable data. |
Study Phase | |
Study Type ICMJE | Observational |
Study Design ICMJE | Case Control, Prospective |
Condition ICMJE | Squamous Cell Carcinoma of Head and Neck |
Intervention ICMJE | Other: Observations This is a non-interventional, observation study, no additional investigational product is being utilized in this PK study |
Study Arms / Comparison Groups |
|
Recruitment Information
Estimated Enrollment ICMJE | 30 | ||||
---|---|---|---|---|---|
Estimated Completion Date | June 2009 | ||||
Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
| ||||
Location Countries ICMJE | Argentina, Belgium, France, Japan, Romania, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00756444 | ||||
---|---|---|---|---|---|
Responsible Party | Global Development Leader, Amgen Inc. | ||||
Study ID Numbers ICMJE | 20080008 | ||||
Study Sponsor ICMJE | Amgen | ||||
Collaborators ICMJE | Takeda Global Research & Development Center, Inc. | ||||
Investigators ICMJE |
| ||||
Information Provided By | Amgen |