Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00261846
First received: December 2, 2005
Last updated: September 9, 2014
Last verified: September 2014
Results First Received: October 4, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Myeloid Leukemia
Intervention: Drug: Bosutinib

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bosutinib 400 mg (Part 1) Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
Bosutinib 500 mg (Part 1) Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
Bosutinib 600 mg (Part 1) Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. Eleven participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
Bosutinib 500 mg, CP2L-CML IM-R (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, CP2L-CML IM-I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, AP-CML IM R/I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, BP-CML IM R/I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, Ph+ ALL (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.

Participant Flow for 2 periods

Period 1:   Part 1: Dose-escalation Phase
    Bosutinib 400 mg (Part 1)     Bosutinib 500 mg (Part 1)     Bosutinib 600 mg (Part 1)     Bosutinib 500 mg, CP2L-CML IM-R (Part 2)     Bosutinib 500 mg, CP2L-CML IM-I (Part 2)     Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)     Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)     Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)     Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)     Bosutinib 500 mg, AP-CML IM R/I (Part 2)     Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)     Bosutinib 500 mg, BP-CML IM R/I (Part 2)     Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)     Bosutinib 500 mg, Ph+ ALL (Part 2)  
STARTED     3     3     12     0     0     0     0     0     0     0     0     0     0     0  
COMPLETED     0     0     0     0     0     0     0     0     0     0     0     0     0     0  
NOT COMPLETED     3     3     12     0     0     0     0     0     0     0     0     0     0     0  
Continued in to Part 2: Efficacy                 3                 3                 12                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  

Period 2:   Part 2: Efficacy
    Bosutinib 400 mg (Part 1)     Bosutinib 500 mg (Part 1)     Bosutinib 600 mg (Part 1)     Bosutinib 500 mg, CP2L-CML IM-R (Part 2)     Bosutinib 500 mg, CP2L-CML IM-I (Part 2)     Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)     Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)     Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)     Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)     Bosutinib 500 mg, AP-CML IM R/I (Part 2)     Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)     Bosutinib 500 mg, BP-CML IM R/I (Part 2)     Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)     Bosutinib 500 mg, Ph+ ALL (Part 2)  
STARTED     0     0     0     200 [1]   88     37     50     27     4     46 [2]   31     35     29     24  
COMPLETED     0     0     0     38     28     4     17     1     2     4     6     9     3     1  
NOT COMPLETED     0     0     0     162     60     33     33     26     2     42     25     26     26     23  
Active on treatment                 0                 0                 0                 92                 37                 6                 16                 11                 1                 10                 5                 1                 2                 1  
Active on long term follow-up                 0                 0                 0                 27                 12                 9                 6                 10                 0                 12                 3                 4                 0                 0  
Death                 0                 0                 0                 28                 4                 10                 7                 4                 1                 14                 15                 19                 23                 22  
Lost to Follow-up                 0                 0                 0                 7                 3                 4                 0                 1                 0                 3                 1                 1                 1                 0  
Withdrawal by Subject                 0                 0                 0                 7                 3                 3                 2                 0                 0                 1                 1                 0                 0                 0  
Unspecified                 0                 0                 0                 1                 1                 1                 2                 0                 0                 1                 0                 1                 0                 0  
Randomized, not treated                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0                 0                 0                 0  
[1] 17 participants from Part 1 (Bosutinib 400mg, 500mg, 600mg cohort) continued in Part 2 of the study.
[2] 1 participant from Part 1 (Bosutinib 600mg cohort) continued in Part 2 of the study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Bosutinib 500 mg, CP2L-CML IM-R (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, CP2L-CML IM-I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, AP-CML IM R/I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, BP-CML IM R/I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Bosutinib 500 mg, Ph+ ALL (Part 2) Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
Total Total of all reporting groups

Baseline Measures
    Bosutinib 500 mg, CP2L-CML IM-R (Part 2)     Bosutinib 500 mg, CP2L-CML IM-I (Part 2)     Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)     Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)     Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)     Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)     Bosutinib 500 mg, AP-CML IM R/I (Part 2)     Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)     Bosutinib 500 mg, BP-CML IM R/I (Part 2)     Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)     Bosutinib 500 mg, Ph+ ALL (Part 2)     Total  
Number of Participants  
[units: participants]
  200     88     37     50     27     4     45     31     35     29     24     570  
Age, Customized  
[units: participants]
                       
Less than 65 years     163     61     30     34     25     4     42     26     32     21     13     451  
Greater than or equal to 65 years     37     27     7     16     2     0     3     5     3     8     11     119  
Gender  
[units: participants]
                       
Female     84     51     23     27     13     2     21     13     11     12     12     269  
Male     116     37     14     23     14     2     24     18     24     17     12     301  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Dose Limiting Toxicity (DLT)   [ Time Frame: Part 1 Baseline up to Day 28 ]

2.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: Part 1 Baseline up to Day 28 ]

3.  Primary:   Maximum Observed Plasma Concentration (Cmax) - Part 1   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ]

4.  Primary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ]

5.  Primary:   Plasma Decay Half-Life (t1/2) - Part 1   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ]

6.  Primary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ]

7.  Primary:   Area Under the Concentration-Time Curve (AUC) - Part 1   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ]

8.  Primary:   Apparent Oral Clearance (CL/F) - Part 1   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ]

9.  Primary:   Apparent Volume of Distribution (Vz/F) - Part 1   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1 ]

10.  Primary:   Maximum Observed Plasma Concentration at Steady State (Cmax,ss) - Part 1   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15 ]

11.  Primary:   Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) - Part 1   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15 ]

12.  Primary:   Plasma Decay Half-Life at Steady State (t1/2,ss) - Part 1   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15 ]

13.  Primary:   Area Under the Concentration-Time Curve at Steady State (AUCss) - Part 1   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15 ]

14.  Primary:   Apparent Oral Clearance at Steady State (CL/F,ss) - Part 1   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15 ]

15.  Primary:   Accumulation Ratio (R)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 1 and Day 15 ]

16.  Primary:   Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Second-line Imatinib Resistant CML Population - Part 2   [ Time Frame: Week 24 ]

17.  Secondary:   Percentage of Participants With Major Cytogenetic Response (MCyR) - Part 1   [ Time Frame: Baseline, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ]

18.  Secondary:   Phosphorylation Inhibition of Breakpoint Cluster Region-Abelson Kinase (Bcr-Abl) - Part 1   [ Time Frame: Baseline, Week 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ]

19.  Secondary:   Phosphorylated Cancer-Testis 10 (CT10) Regulator of Kinase Like (p-CrkL) Protein Level in Blood at Baseline – Part 1   [ Time Frame: 0 (pre-dose) on Day 1 (Baseline) ]

20.  Secondary:   Percent Change From Baseline in Phosphorylated Cancer-testis 10 (CT10) Regulator of Kinase Like (p-CrkL) Protein Level in Blood at Day 1, 8 and 15 - Part 1   [ Time Frame: 6 hours post-dose on Day 1, 0 (pre-dose), 6 hours post-dose on Day 8, 15 ]

21.  Secondary:   Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line Imatinib Intolerant CML and Chronic Phase Third-line CML Population - Part 2   [ Time Frame: Week 24 for second line, Baseline through Week 24 for third line ]

22.  Secondary:   Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML and Chronic Phase Third-line CML - Part 2   [ Time Frame: Baseline, Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ]

23.  Secondary:   Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML and Chronic Phase Third-line CML - Part 2   [ Time Frame: Baseline, Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ]

24.  Secondary:   Time to Achieve Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML and Chronic Phase Third-line CML - Part 2   [ Time Frame: Baseline, Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ]

25.  Secondary:   Duration of Complete Hematologic Response (CHR) - Part 2   [ Time Frame: Baseline, Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ]

26.  Secondary:   Time to Achieve Complete Hematologic Response (CHR) - Part 2   [ Time Frame: Baseline, Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ]

27.  Secondary:   Progression Free Survival (PFS) Rate - Part 2   [ Time Frame: Baseline up to Year 1, Year 2 ]

28.  Secondary:   Overall Survival (OS) Rate - Part 2   [ Time Frame: Baseline up to Year 2 ]

29.  Secondary:   Percentage of Participants With Complete Hematologic Response (CHR) in Advanced Leukemia Population - Part 2   [ Time Frame: Baseline, Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ]

30.  Secondary:   Percentage of Participants With Overall Hematologic Response (OHR) by Week 48 in Advanced Leukemia Population - Part 2   [ Time Frame: Week 48 ]

31.  Secondary:   Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to follow up visit (30 days after last dose of study treatment) ]

32.  Secondary:   Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)   [ Time Frame: Baseline up to follow up visit (30 days after last dose of study treatment) ]

33.  Secondary:   Number of Participants With Change From Baseline in Laboratory Tests Results   [ Time Frame: Week 1, 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ]

34.  Secondary:   Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings   [ Time Frame: Baseline, 0 (pre-dose), 2, 4, 6 hours on Day 1, 0 (pre-dose), 2, 4, 6, 20-23 hours on Day 21, and end of treatment visit ]

35.  Secondary:   Number of Participants With Change From Baseline in Findings of Chest X-ray   [ Time Frame: Baseline, Week 8, and end of treatment ]

36.  Secondary:   Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)   [ Time Frame: Baseline up to end of treatment (Year 5) ]

37.  Secondary:   Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group Performance Status (ECOG-PS)   [ Time Frame: Baseline, Week 1, 2, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5 ]

38.  Secondary:   Number of Participants With Change From Baseline in Physical Examinations and Vital Signs   [ Time Frame: Baseline up to end of treatment (Year 5) ]

39.  Primary:   Population Pharmacokinetics - Part 2   [ Time Frame: 0 (pre-dose), 2, 4, 6 hours on Day 1, Day 21, 20-23 hours post-dose on Day 21, 0 (pre-dose) hours on Day 84, 168, 252 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Analyses of progression free survival and overall survival was based on all-treated population, instead of evaluable population which was the primary efficacy population as per planned analyses.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00261846     History of Changes
Other Study ID Numbers: 3160A4-200, B1871006, 3160A4-200-WW
Study First Received: December 2, 2005
Results First Received: October 4, 2012
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration