NCT01059643 · OUTCOME
Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck · Source last updated 2019-09-18
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Baseline until progressive disease up to 36 weeks post-baseline
What was measured
The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Analysis population: All enrolled participants who received at least 1 dose of study drug.
Groups in this outcome
LY2523355
LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| LY2523355 | 103 |
|---|
Reported measurements
Colorectal Cancer
Analysis denominator · Participants
| Group | Source count |
|---|
| LY2523355 | 17 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| LY2523355 | 0 | Not reported | 0.0 | 17.1 | Not reported |
|---|
Gastroesophageal Cancer
Analysis denominator · Participants
| Group | Source count |
|---|
| LY2523355 | 13 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| LY2523355 | 0 | Not reported | 0.0 | 22.1 | Not reported |
|---|
Non-Small Cell Lung Cancer
Analysis denominator · Participants
| Group | Source count |
|---|
| LY2523355 | 29 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| LY2523355 | 0 | Not reported | 0.0 | 10.9 | Not reported |
|---|
Ovarian Cancer
Analysis denominator · Participants
| Group | Source count |
|---|
| LY2523355 | 13 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| LY2523355 | 0 | Not reported | 0.0 | 20.6 | Not reported |
|---|
Prostate Cancer
Analysis denominator · Participants
| Group | Source count |
|---|
| LY2523355 | 18 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| LY2523355 | 0 | Not reported | 0.0 | 16.2 | Not reported |
|---|
Squamous Cell Carcinoma of Head and Neck
Analysis denominator · Participants
| Group | Source count |
|---|
| LY2523355 | 13 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| LY2523355 | 0 | Not reported | 0.0 | 25.9 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 17.1
- value
- 0
- title
- Colorectal Cancer
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 22.1
- value
- 0
- title
- Gastroesophageal Cancer
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 10.9
- value
- 0
- title
- Non-Small Cell Lung Cancer
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 20.6
- value
- 0
- title
- Ovarian Cancer
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 16.2
- value
- 0
- title
- Prostate Cancer
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 25.9
- value
- 0
- title
- Squamous Cell Carcinoma of Head and Neck
- description
- The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment.
Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
- id
- OG000
- title
- LY2523355
- param Type
- NUMBER
- population Description
- All enrolled participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Baseline until progressive disease up to 36 weeks post-baseline
- title
- Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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