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Trial record 4 of 16 for:    11784875 [PUBMED-IDS]

A Phase I/II Study of Paclitaxel, Carboplatin and YM155 (Survivin Suppressor) in Subjects With Solid Tumors (Phase I) and Advanced Non-Small Cell Lung Carcinoma (Phase II)

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ClinicalTrials.gov Identifier: NCT01100931
Recruitment Status : Completed
First Posted : April 9, 2010
Results First Posted : April 4, 2013
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: NSCLC
Solid Tumors
Interventions: Drug: YM155
Drug: Carboplatin
Drug: Paclitaxel

  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
One patient withdrew consent before starting treatment.

Reporting Groups
  Description
Phase I Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
Phase II Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.

Participant Flow for 2 periods

Period 1:   Phase I
    Phase I   Phase II
STARTED   22   0 
COMPLETED   22   0 
NOT COMPLETED   0   0 

Period 2:   Phase II
    Phase I   Phase II
STARTED   0   19 
COMPLETED   0   19 
NOT COMPLETED   0   0 



  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.
No text entered.

Reporting Groups
  Description
Phase I Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
Phase II Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
Total Total of all reporting groups

Baseline Measures
   Phase I   Phase II   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   19   41 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   14   13   27 
>=65 years   8   6   14 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.3  (10.72)   59.8  (9.51)   61.6  (10.14) 
Gender 
[Units: Participants]
     
Female   12   8   20 
Male   10   11   21 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   3   2   5 
Not Hispanic or Latino   19   17   36 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   6   0   6 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   3   3   6 
White   13   14   27 
More than one race   0   0   0 
Unknown or Not Reported   0   1   1 
Region of Enrollment 
[Units: Participants]
     
United States   22   19   41 


  Outcome Measures

1.  Primary:   Phase 1 Safe and Tolerable Phase 2 Dose.   [ Time Frame: 1 year ]

2.  Primary:   Phase 2 Objective Response Rate (Partial Response (PR) + Complete Response (CR)).   [ Time Frame: up to 18 weeks ]

3.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 31.5 months ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Giuseppe Giaccone
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-4916
e-mail: giacconeg@mail.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01100931     History of Changes
Other Study ID Numbers: 100051
10-C-0051
First Submitted: April 8, 2010
First Posted: April 9, 2010
Results First Submitted: February 21, 2013
Results First Posted: April 4, 2013
Last Update Posted: October 19, 2015