NCT01139775 · OUTCOME
Phase 1: Document Any Antitumor Activity Per Radiological Scans and/or Tumor Markers
A Study in Non Small Cell Lung Cancer · Source last updated 2018-05-18
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 through end of Phase 1
What was measured
Overall response rate is presented. Overall response rate is defined as the percentage of participants with a best response of CR or PR as classified by the investigators according to RECIST, v1.1 criteria. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Analysis population: All randomized Phase 1 participants.
Groups in this outcome
Phase 1: Pemetrexed + Cisplatin + LY2603618
Cycles 1-2 (21-day cycle):
Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2
Day 2: LY2603618 130 to 275 mg
After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.
Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
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 |
|---|
| Phase 1: Pemetrexed + Cisplatin + LY2603618 | 14 |
|---|
Reported measurements
130 mg
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1: Pemetrexed + Cisplatin + LY2603618 | 3 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Pemetrexed + Cisplatin + LY2603618 | 0 | Not reported | 0 | 0 | Not reported |
|---|
185 mg
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1: Pemetrexed + Cisplatin + LY2603618 | 3 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Pemetrexed + Cisplatin + LY2603618 | 66.7 | Not reported | 9.0 | 99.0 | Not reported |
|---|
240 mg
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1: Pemetrexed + Cisplatin + LY2603618 | 4 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Pemetrexed + Cisplatin + LY2603618 | 25.0 | Not reported | 1.0 | 81.0 | Not reported |
|---|
275 mg
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1: Pemetrexed + Cisplatin + LY2603618 | 4 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Pemetrexed + Cisplatin + LY2603618 | 0 | Not reported | 0 | 0 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- title
- 130 mg
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.0
- upper Limit
- 99.0
- value
- 66.7
- title
- 185 mg
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 81.0
- value
- 25.0
- title
- 240 mg
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- title
- 275 mg
- description
- Overall response rate is presented. Overall response rate is defined as the percentage of participants with a best response of CR or PR as classified by the investigators according to RECIST, v1.1 criteria. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Cycles 1-2 (21-day cycle):
Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2
Day 2: LY2603618 130 to 275 mg
After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met.
Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
- id
- OG000
- title
- Phase 1: Pemetrexed + Cisplatin + LY2603618
- param Type
- NUMBER
- population Description
- All randomized Phase 1 participants.
- reporting Status
- POSTED
- time Frame
- Baseline through end of Phase 1
- title
- Phase 1: Document Any Antitumor Activity Per Radiological Scans and/or Tumor Markers
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle