Colorectal NeoplasmsPhase 1NCT00599924
Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors
A Phase 1 study testing sunitinib + FOLFOX in people with Colorectal Neoplasms and Neoplasms, run by Pfizer at 3 sites in United States.
Trial summary
This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX [Leucovorin + Fluorouracil (5-FU) + Oxaliplatin]. Three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2, Schedule 4/2, and Continuous Dosing) were tested… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Neoplasms
- What is being tested?
- sunitinib + FOLFOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2005to Nov 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced solid tumor malignancy (during expansion at the maximum tolerated dose, entry will be limited to patients wtih adenocarcinoma of the colon or rectum)
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
Who cannot join
- Prior treatment with more than 6 cycles of traditional alkylating agent-based chemotherapy regimens
- Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens
- For colorectal cancer patients in the expanded cohorts, prior treatment with more than 2 systemic chemotherapy regimens in the metastatic setting
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
Aurora, Colorado, 80045
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Nashville, Tennessee, 37232
About this study
Official title: Phase I Study Of SU011248 In Combination With Oxaliplatin, Leucovorin, And 5-Fluorouracil In Patients With Advanced Solid Malignancies
This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX [Leucovorin + Fluorouracil (5-FU) + Oxaliplatin]. Three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2, Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors, including colorectal cancer.
Read the detailed description
Study Design: Treatment, Single Group Assignment (7 cohorts), Open Label, Non-Randomized, Safety Study.
- Conditions
- Colorectal Neoplasms, Neoplasms
- Being tested
- sunitinib + FOLFOX
- Keywords
- advanced solid tumors,, colorectal cancer,, sunitinib (SUTENT),, FOLFOX
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib + FOLFOXDrug
Also called Sunitinib malate, SUTENT, mFOLFOX6
37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2)
sunitinib + FOLFOXDrug
Also called Sunitinib malate, SUTENT, mFOLFOX6
50 mg sunitinib + modified FOLFOX6 (Schedule 2/2)
sunitinib + FOLFOXDrug
Also called Sunitinib malate, SUTENT, mFOLFOX6
50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2)
sunitinib + FOLFOXDrug
Also called Sunitinib malate, SUTENT, mFOLFOX6
37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2)
sunitinib + FOLFOXDrug
Also called Sunitinib malate, SUTENT, mFOLFOX6
50 mg sunitinib + modified FOLFOX6 (Schedule 4/2)
sunitinib + FOLFOXDrug
Also called Sunitinib malate, SUTENT, mFOLFOX6
37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
sunitinib + FOLFOXDrug
Also called Sunitinib malate, SUTENT, mFOLFOX6
25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | SU011248 [sunitinib] in combination with FOLFOX; FOLFOX is a chemotherapy regimen that combines oxaliplatin and leucovorin with bolus and infusion 5-FU. The modified FOLFOX 6 (mFOLFOX6) regimen is one of several different regimens of FOLFOX used in clinic, according to different dosages of the 4 drugs. mFOLFOX6 was administered every 2 weeks on Days 1 and 2 of each cycle.
25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in three different dosing regimens: schedule 2/2 (2 weeks on, 2 weeks off), schedule 4/2 (4 weeks on, 2 weeks off), and continuous daily dosing (every day); FOLFOX will be administered every 2 weeks, using the modified FOLFOX 6 (mFOLFOX6) regimen, consisting of: oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 as a 2-hr IV infusion; 5-FU 400 mg/m2 IV bolus, followed by - 5-FU 2400 mg/m2 as a 46-hr IV infusion Receives: Drug: sunitinib + FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
Measured: up to 20 weeks
Secondary outcomes (29)
Objective Response (OR)
From the start of treatment until disease progression/recurrence. OR=confirmed Complete Response (CR) or confirmed Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR = disappearance of all target lesions. CR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response. PR = ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. PR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.
Measured: From start of treatment until Day 8 of Cycles 4 and 8 (2/2 Schedule), Day 8 of Cycles 3 and 6 (4/2 Schedule), and Day 1 of Cycles 3 and 7 (Continuous Dosing)
Maximum Plasma Concentration (Cmax) of Sunitinib
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Time to Cmax (Tmax) of Sunitinib
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Minimum Plasma Concentration (Cmin) of Sunitinib
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Clearance (CL/F) of Sunitinib
Drug clearance (CL/F) = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib
AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Terminal Phase Half-Life (t1/2) of Sunitinib
t1/2 = terminal phase half-life. t1/2 was obtained by natural log of 2 (ln2) divided by the rate constant for terminal phase (kel).
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Cmax of SU-012662 (Sunitinib's Metabolite)
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Tmax of SU-012662 (Sunitinib's Metabolite)
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Cmin of SU-012662 (Sunitinib's Metabolite)
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
AUC24 for SU-012662 (Sunitinib's Metabolite)
AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose.
CL/F of SU-012662 (Sunitinib's Metabolite)
CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
T1/2 of SU-012662 (Sunitinib's Metabolite)
t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel.
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Cmax of Free Platinum
Oxaliplatin was metabolized to platinum and free platinum was measured.
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Tmax of Free Platinum
Oxaliplatin was metabolized to platinum and free platinum was measured.
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum
Oxaliplatin was metabolized to platinum and free platinum was measured. AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity. AUCinf was obtained by the Linear/Log trapezoidal method.
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
T1/2 for Free Platinum
t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free platinum was measured.
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Cmax of Total Platinum
Oxaliplatin was metabolized to platinum and total platinum was measured.
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Tmax of Total Platinum
Oxaliplatin was metabolized to platinum and total platinum was measured.
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum
Oxaliplatin was metabolized to platinum and total platinum was measured. AUC48 = Area under the plasma concentration-time profile from time zero (pre-dose) to forty-eight hours. AUC48 was obtained by the Linear/Log trapezoidal method.
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Steady State Concentration (Css) of Fluorouracil (5-FU)
Steady state is reached when the amount of drug getting into the system per unit time is equal to the amount of drug cleared from the system.
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Steady State Clearance (CLss) of 5-FU
CLss was determined by total amount of drug received during infusion or duration of infusion (Ki) divided by Css.
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Area Under the Curve (AUC) of 5-FU
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Cmax of 5-FU
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
T1/2 of Free Platinum, Total Platinum, and 5-FU
t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free and total platinum were measured.
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
CL/F of Free Platinum, Total Platinum, and 5-FU
CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.
Measured: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Cmin of Free Platinum, Total Platinum, and 5-FU
Measured: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Volume Endothelial Transfer Constant (Ktrans) of Tumors in a Selected Group of Subjects Assessed by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)
Volume endothelial Ktrans was estimated by fitting the tissue contrast agent time course to the Kety equation (Tofts model for analysis of DCE-MRI data).
Measured: Cycle 3 (Day 1), Cycle 3 (Day 8)
Initial Area Dnder the Contrast Agent Concentration-Time Curve (IAUC) of Tumors in a Selected Group of Subjects Assessed by DCE-MRI
IAUC: The initial area under the curve was estimated by integrating the area under the contrast agent concentration time course for the first 90 seconds after bolus arrival in the tumor.
Measured: Cycle 3 (Day 1) and Cycle 3 (Day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startSep 2005
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599924
- Sponsor's protocol ID
- A6181048
- Status last verified
- Jun 2015
- First submitted
- 11 Jan 2008
- Last updated
- 15 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Of SU011248 In Combination With Oxaliplatin, Leucovorin, And 5-Fluorouracil In Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00599924
- Acronym / sponsor ID
- A6181048
- Conditions
- Colorectal Neoplasms, Neoplasms
- Keywords
- advanced solid tumors,, colorectal cancer,, sunitinib (SUTENT),, FOLFOX
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 24 Jan 2008 (estimated)
- Results
- Posted 9 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX [Leucovorin + Fluorouracil (5-FU) + Oxaliplatin]. Three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2, Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors, including colorectal cancer.
Detailed description
Study Design: Treatment, Single Group Assignment (7 cohorts), Open Label, Non-Randomized, Safety Study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: sunitinib + FOLFOXSU011248 [sunitinib] in combination with FOLFOX; FOLFOX is a chemotherapy regimen that combines oxaliplatin and leucovorin with bolus and infusion 5-FU. The modified FOLFOX 6 (mFOLFOX6) regimen is one of several different regimens of FOLFOX used in clinic, according to different dosages of the 4 drugs. mFOLFOX6 was administered every 2 weeks on Days 1 and 2 of each cycle. 25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in three different dosing regimens: schedule 2/2 (2 weeks on, 2 weeks off), schedule 4/2 (4 weeks on, 2 weeks off), and continuous daily dosing (every day); FOLFOX will be administered every 2 weeks, using the modified FOLFOX 6 (mFOLFOX6) regimen, consisting of: oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 as a 2-hr IV infusion; 5-FU 400 mg/m2 IV bolus, followed by - 5-FU 2400 mg/m2 as a 46-hr IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Advanced solid tumor malignancy (during expansion at the maximum tolerated dose, entry will be limited to patients wtih adenocarcinoma of the colon or rectum)
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
Key exclusion criteria (3 listed)
- Prior treatment with more than 6 cycles of traditional alkylating agent-based chemotherapy regimens
- Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens
- For colorectal cancer patients in the expanded cohorts, prior treatment with more than 2 systemic chemotherapy regimens in the metastatic setting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sunitinib + FOLFOXAlso: Sunitinib malate, SUTENT, mFOLFOX637.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2) | Drug | Single arm |
| sunitinib + FOLFOXAlso: Sunitinib malate, SUTENT, mFOLFOX650 mg sunitinib + modified FOLFOX6 (Schedule 2/2) | Drug | Single arm |
| sunitinib + FOLFOXAlso: Sunitinib malate, SUTENT, mFOLFOX650 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2) | Drug | Single arm |
| sunitinib + FOLFOXAlso: Sunitinib malate, SUTENT, mFOLFOX637.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2) | Drug | Single arm |
| sunitinib + FOLFOXAlso: Sunitinib malate, SUTENT, mFOLFOX650 mg sunitinib + modified FOLFOX6 (Schedule 4/2) | Drug | Single arm |
| sunitinib + FOLFOXAlso: Sunitinib malate, SUTENT, mFOLFOX637.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing) | Drug | Single arm |
| sunitinib + FOLFOXAlso: Sunitinib malate, SUTENT, mFOLFOX625 mg sunitinib + modified FOLFOX6 (Continuous Dosing) | Drug | Single arm |
Primary outcome
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: up to 20 weeks
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
29 secondary outcomes
Objective Response (OR)
Time frame: From start of treatment until Day 8 of Cycles 4 and 8 (2/2 Schedule), Day 8 of Cycles 3 and 6 (4/2 Schedule), and Day 1 of Cycles 3 and 7 (Continuous Dosing)
Maximum Plasma Concentration (Cmax) of Sunitinib
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Time to Cmax (Tmax) of Sunitinib
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Minimum Plasma Concentration (Cmin) of Sunitinib
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Clearance (CL/F) of Sunitinib
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Terminal Phase Half-Life (t1/2) of Sunitinib
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Cmax of SU-012662 (Sunitinib's Metabolite)
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Tmax of SU-012662 (Sunitinib's Metabolite)
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Cmin of SU-012662 (Sunitinib's Metabolite)
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
AUC24 for SU-012662 (Sunitinib's Metabolite)
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose.
CL/F of SU-012662 (Sunitinib's Metabolite)
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
T1/2 of SU-012662 (Sunitinib's Metabolite)
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Cmax of Free Platinum
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Tmax of Free Platinum
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
T1/2 for Free Platinum
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Cmax of Total Platinum
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Tmax of Total Platinum
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Steady State Concentration (Css) of Fluorouracil (5-FU)
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Steady State Clearance (CLss) of 5-FU
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Area Under the Curve (AUC) of 5-FU
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Cmax of 5-FU
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
T1/2 of Free Platinum, Total Platinum, and 5-FU
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
CL/F of Free Platinum, Total Platinum, and 5-FU
Time frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Cmin of Free Platinum, Total Platinum, and 5-FU
Time frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Volume Endothelial Transfer Constant (Ktrans) of Tumors in a Selected Group of Subjects Assessed by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)
Time frame: Cycle 3 (Day 1), Cycle 3 (Day 8)
Initial Area Dnder the Contrast Agent Concentration-Time Curve (IAUC) of Tumors in a Selected Group of Subjects Assessed by DCE-MRI
Time frame: Cycle 3 (Day 1) and Cycle 3 (Day 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sunitinib + FOLFOX in people with Colorectal Neoplasms and Neoplasms, run by Pfizer at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.