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A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols

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ClinicalTrials.gov Identifier: NCT00884312
Recruitment Status : Completed
First Posted : April 20, 2009
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Multiple Myeloma
Solid Tumors
Intervention: Drug: Carfilzomib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 23 centers in the United States and Canada from April 2009 to May 2017.

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
Solid Tumors Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Multiple Myeloma Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.

Participant Flow:   Overall Study
    Solid Tumors   Multiple Myeloma
STARTED   9   92 
Received Treatment   9   91 
COMPLETED [1]   7   67 
NOT COMPLETED   2   25 
Non-fatal Progressive Disease                0                8 
Fatal Progressive Disease                0                1 
Non-fatal Adverse Event                1                0 
Fatal Adverse Event                1                4 
Withdrawal by Subject                0                6 
Physician Decision                0                1 
Other                0                4 
Did Not Receive Study Drug                0                1 
[1] Completed final visit



  Baseline Characteristics

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.
All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.

Reporting Groups
  Description
Solid Tumors Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Multiple Myeloma Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Total Total of all reporting groups

Baseline Measures
   Solid Tumors   Multiple Myeloma   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   91   100 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.2  (12.75)   63.2  (9.82)   63.0  (10.05) 
Age, Customized 
[Units: Participants]
Count of Participants
     
< 65 years      5  55.6%      47  51.6%      52  52.0% 
≥ 65 years      4  44.4%      44  48.4%      48  48.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  66.7%      38  41.8%      44  44.0% 
Male      3  33.3%      53  58.2%      56  56.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White      9 100.0%      71  78.0%      80  80.0% 
Black      0   0.0%      11  12.1%      11  11.0% 
Hispanic      0   0.0%      5   5.5%      5   5.0% 
Asian/Pacific Islander      0   0.0%      4   4.4%      4   4.0% 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
Count of Participants
     
0 (Fully active)      6  66.7%      39  42.9%      45  45.0% 
1 (Restricted but ambulatory)      3  33.3%      42  46.2%      45  45.0% 
2 (Ambulatory but unable to work)      0   0.0%      10  11.0%      10  10.0% 
[1] A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.


  Outcome Measures

1.  Primary:   Number of Participants With Peripheral Neuropathy   [ Time Frame: From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. ]

2.  Primary:   Number of Participants With Adverse Events   [ Time Frame: From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. ]

3.  Secondary:   Overall Survival   [ Time Frame: From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. ]

4.  Secondary:   Progression-free Survival   [ Time Frame: From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. ]

5.  Secondary:   Time to Progression   [ Time Frame: From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: Study Director
Organization: Amgen Inc.
phone: 866-572-6436
e-mail: medinfo@amgen.com



Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00884312     History of Changes
Other Study ID Numbers: PX-171-010
20130394 ( Other Identifier: Amgen Study ID )
First Submitted: April 16, 2009
First Posted: April 20, 2009
Results First Submitted: April 9, 2018
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018