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 |
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Recruitment Status :
Completed
First Posted : April 9, 2010
Results First Posted : April 4, 2013
Last Update Posted : October 19, 2015
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Conditions |
NSCLC Solid Tumors |
| Interventions |
Drug: YM155 Drug: Carboplatin Drug: Paclitaxel |
| Enrollment | 42 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | One patient withdrew consent before starting treatment. |
| Arm/Group Title | Phase I | Phase II |
|---|---|---|
 Arm/Group Description |
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: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days. |
| Period Title: Phase I | ||
| Started | 22 | 0 |
| Completed | 22 | 0 |
| Not Completed | 0 | 0 |
| Period Title: Phase II | ||
| Started | 0 | 19 |
| Completed | 0 | 19 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Phase I | Phase II | Total | |
|---|---|---|---|---|
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Arm/Group Description |
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: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 22 | 19 | 41 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 22 participants | 19 participants | 41 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
14 63.6%
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13 68.4%
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27 65.9%
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| >=65 years |
8 36.4%
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6 31.6%
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14 34.1%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 22 participants | 19 participants | 41 participants | |
| 62.3 (10.72) | 59.8 (9.51) | 61.6 (10.14) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 22 participants | 19 participants | 41 participants | |
| Female |
12 54.5%
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8 42.1%
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20 48.8%
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| Male |
10 45.5%
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11 57.9%
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21 51.2%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 22 participants | 19 participants | 41 participants | |
| Hispanic or Latino |
3 13.6%
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2 10.5%
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5 12.2%
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| Not Hispanic or Latino |
19 86.4%
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17 89.5%
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36 87.8%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 22 participants | 19 participants | 41 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
6 27.3%
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0 0.0%
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6 14.6%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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1 5.3%
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1 2.4%
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| Black or African American |
3 13.6%
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3 15.8%
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6 14.6%
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| White |
13 59.1%
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14 73.7%
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27 65.9%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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1 5.3%
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1 2.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 22 participants | 19 participants | 41 participants |
| 22 | 19 | 41 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Dr. Giuseppe Giaccone |
| Organization: | National Cancer Institute, National Institutes of Health |
| Phone: | 301-496-4916 |
| EMail: | 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 |
| 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 |