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Study Of Sunitinib With Capecitabine In Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00662025
First received: April 17, 2008
Last updated: May 22, 2013
Last verified: May 2013

April 17, 2008
May 22, 2013
April 2008
December 2009   (final data collection date for primary outcome measure)
Number of Participants With Objective Response Based on Data Review Committee's Assessment [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. ] [ Designated as safety issue: No ]
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.
Objective response rate (ORR) [ Time Frame: 24 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00662025 on ClinicalTrials.gov Archive Site
  • Number of Participants With Objective Response Based on Investigator's Assessment [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study. ] [ Designated as safety issue: No ]
    Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.
  • Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. ] [ Designated as safety issue: No ]
    Number of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.
  • Number of Subjects With CBR Based on Investigator's Assessment [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study. ] [ Designated as safety issue: No ]
    Number of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.
  • Progression-Free Survival (PFS) [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. ] [ Designated as safety issue: No ]
    Based on Data Review Committee's Assessment. PFS is defined as the time from the start of study treatment to first documentation of objective tumor progression, or to death on study due to any cause, whichever occurred first.
  • Time to Tumor Progression (TTP) [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. ] [ Designated as safety issue: No ]
    Based on Data Review Committee's Assessment. TTP is defined as the time from the start of study treatment to first documentation of objective tumor progression.
  • Duration of Objective Tumor Response (DR) [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. ] [ Designated as safety issue: No ]
    Based on Data Review Committee's Assessment. DR is defined as the time from the first documentation of objective tumor response (confirmed CR or PR) to the first documentation of disease progression or to death due to cancer, whichever occurred first. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.
  • Time to Objective Tumor Response (TTR) [ Time Frame: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. ] [ Designated as safety issue: No ]
    Based on Data Review Committee's Assessment. TTR is defined as the time from the start of study treatment to first documentation of objective tumor response (confirmed CR or PR). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.
  • Overall Survival (OS) [ Time Frame: A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study. ] [ Designated as safety issue: No ]
    OS is defined as the time from the start of study treatment to death due to any cause. OS data is censored on the last day they were known to be alive in the absence of confirmation of death.
  • Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) [ Time Frame: Days 14 and 15 of Cycle 1 ] [ Designated as safety issue: No ]

    SU012662 is a metabolite of sunitinib. Trough plasma concentration (Ctrough) means the concentration prior to study drug administration.

    The Ctrough for total drug (sunitinib+SU012662) was calculated as the mean of the Ctrough of total drug from individual participant.

  • Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) [ Time Frame: Days 14 and 15 of Cycle 1 ] [ Designated as safety issue: No ]

    SU012662 is a metabolite of sunitinib. Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).

    The Tmax for total drug (sunitinib+SU012662) was calculated as the median of the Tmax of total drug from individual participant.

  • Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) [ Time Frame: Days 14 and 15 of Cycle 1 ] [ Designated as safety issue: No ]

    SU012662 is a metabolite of sunitinib. Cmax means a maximum observed plasma concentration.

    The Cmax for total drug (sunitinib+SU012662) was calculated as the mean of the Cmax of total drug from individual participant.

  • AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) [ Time Frame: Days 14 and 15 of Cycle 1 ] [ Designated as safety issue: No ]

    SU012662 is a metabolite of sunitinib. AUC(0-24) means an area under the plasma concentration time curve from time zero to 24 hours post-dose.

    The AUC(0-24) for total drug (sunitinib+SU012662) was calculated as the mean of the AUC(0-24) of total drug from individual participant.

  • Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) [ Time Frame: Day 14 of Cycle 1 ] [ Designated as safety issue: No ]

    Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).

    5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil

  • Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) [ Time Frame: Day 14 of Cycle 1 ] [ Designated as safety issue: No ]
    Cmax means a maximum observed plasma concentration. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil
  • AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) [ Time Frame: Day 14 of Cycle 1 ] [ Designated as safety issue: No ]

    AUC(0-inf) means an area under the plasma concentration time curve from time zero to Infinity.

    5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil

  • t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) [ Time Frame: Day 14 of Cycle 1 ] [ Designated as safety issue: No ]
    t1/2 means a terminal phase half-life. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil
  • Clinical benefit rate (CBR) [ Time Frame: 24month ] [ Designated as safety issue: No ]
  • progression free survival (PFS) [ Time Frame: 24month ] [ Designated as safety issue: No ]
  • overall survival (OS) [ Time Frame: 24month ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 24month ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters of sunitinib, SU012662, capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR), 5'-deoxy-5-fluorouridine (5'-DFUR) and 5-fluorouracil (5-FU) [ Time Frame: 24month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Of Sunitinib With Capecitabine In Breast Cancer
A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer

To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced/Metastatic Breast Cancer
  • Drug: Capecitabine
    Capecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
  • Drug: Sunitinib
    Sunitinib 37.5 mg daily, continuous dosing
Experimental: 1
Interventions:
  • Drug: Capecitabine
  • Drug: Sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
May 2012
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent
  • Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
  • Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.

Exclusion Criteria:

  • Histology of inflammatory carcinoma with no other measurable disease. Patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease.
  • Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease.
  • Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1 (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00662025
A6181163
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP