|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00555620 |
|
Date of registration:
|
06/11/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer
|
|
Scientific title:
|
A Phase 1 Study Of Sunitinib Malate In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer |
|
Date of first enrolment:
|
May 2008 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00555620 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Korea, Republic of
| | | | | | | |
|
Contacts
|
|
Name:
|
Pfizer CT.gov Call Center |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pfizer |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- confirmed diagnosis of stomach cancer
- advanced stomach cancer of stage IV
- adequate blood chemistry, blood counts and kidney function
- willing to participate to study requirements and sign an informed consent document
Exclusion Criteria:
- prior chemotherapy for the stomach cancer in its advanced stage
- excessive toxicities related to prior therapies
- pregnant or breastfeeding patients
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Stomach Neoplasms
|
|
Intervention(s)
|
|
Drug: capecitabine
|
|
Drug: cisplatin
|
|
Drug: oxaliplatin
|
|
Drug: sunitinib malate
|
|
Primary Outcome(s)
|
|
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
[Time Frame: Baseline up to Day 21]
|
|
Secondary Outcome(s)
|
|
Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]): CAP, 5'-Deoxy-5-fluorocytidine (Metabolite of CAP), 5'-Deoxy-5-fluorouridine (Metabolite of CAP), 5-fluorouracil (Metabolite of CAP)
[Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]
|
|
Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]): SU, SU012662 (Metabolite of SU), Total Drug (SU + SU012662)
[Time Frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)]
|
|
Duration of Response (DR)
[Time Frame: Baseline up to Month 15]
|
|
Maximum Observed Plasma Concentration (Cmax): CAP, 5'-Deoxy-5-fluorocytidine (Metabolite of CAP), 5'-Deoxy-5-fluorouridine (Metabolite of CAP), 5-fluorouracil (Metabolite of CAP)
[Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]
|
|
Maximum Observed Plasma Concentration (Cmax): SU, SU012662 (Metabolite of SU), Total Drug (SU + SU012662)
[Time Frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)]
|
|
Number of Participants With Objective Response
[Time Frame: Baseline, Day 21 of every even-numbered cycle up to 15 months]
|
|
Progression-Free Survival (PFS)
[Time Frame: Baseline up to Month 15]
|
|
Terminal Elimination Half-Life (t1/2): CAP, 5'-Deoxy-5-fluorocytidine (Metabolite of CAP), 5'-Deoxy-5-fluorouridine (Metabolite of CAP), 5-fluorouracil (Metabolite of CAP)
[Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]
|
|
Terminal Elimination Half-Life (t1/2): SU, SU012662 (Metabolite of SU), Total Drug (SU + SU012662)
[Time Frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)]
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax): CAP, 5'-Deoxy-5-fluorocytidine (Metabolite of CAP), 5'-Deoxy-5-fluorouridine (Metabolite of CAP), 5-fluorouracil (Metabolite of CAP)
[Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax): SU, SU012662 (Metabolite of SU), Total Drug (SU + SU012662)
[Time Frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|