Trial · NCT01313663
A Study to Evaluate Pazopanib in Comparison to Pemetrexed in Maintenance Setting in Non-progressing Subjects With Metastatic Stage IVA and IVB Non-squamous Non-small Cell Lung Cancer (NSCLC) Population
NCT01313663, Phase 2, Terminated, GlaxoSmithKline; results first posted 2013-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Pazopanib in Comparison to Pemetrexed in Maintenance Setting in Non-progressing Subjects With Metastatic Stage IVA and IVB Non-squamous Non-small Cell Lung Cancer (NSCLC) Population. Trials, record NCT01313663. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01313663
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate Pazopanib in Comparison to Pemetrexed in Maintenance Setting in Non-progressing Subjects With Metastatic Stage IVA and IVB Non-squamous Non-small Cell Lung Cancer (NSCLC) Population
- NCT number
- NCT01313663
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Lung Cancer, Small Cell
- Interventions
- pazopanib, pemetrexed
- First posted
- 2011-03-14
- Last updated
- 2014-10-27
- Results first posted
- 2013-04-29
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From randomization until the first documented sign of investigator-assessed disease progression or death, whichever occurred first (average of 10 study weeks) | PFS is defined as the interval between the date of randomization and the first documented sign of investigator-assessed (per Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1) disease progression (PD) or death, whichever occurs first. The date of documented PD is the date of lesion evaluation in the case of radiological PD and the date of symptomatic cancer progression in the case of symptomatic progression (radiological confirmation is required). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. If the participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was to be censored at the last adequate assessment (LAA) prior to the initiation of therapy. Otherwise, if the participant did not have a documented date of progression or death, PFS was to be censored at the date of the LAA. |
| Secondary | Overall Survival | From randomization until disease progression or death (up to Study Week 78) | Overall survival is defined as the interval between the date of randomization and the date of death from any cause. |
| Secondary | Number of Participants (Par.) With the Indicated Best Overall Response | From randomization until the time of the first documented evidence of a confirmed complete response (CR) or partial response (PR) (average of 10 weeks) | A par. was defined as a responder if s/he sustained a CR (The disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters \[mm\] in the short axis) or PR (At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters) that was confirmed after \>=28 days. Response was evaluated by an investigator per RECIST, version 1.1. A par. without a post-Baseline assessment was considered a non-responder. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started). To qualify as a best response of SD, a response of SD had to be observed \>=12 weeks after randomization. A par. who was not evaluable had no scans at all or did not have a confirmatory scan. |
| Secondary | Number of Participants With Any Non-serious On-therapy Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) and Serious Adverse Event (SAE) | From the time the first dose of study treatment was administered until 28 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (up to Study Week 55) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. |
| Secondary | Time on Study Treatment (Pazopanib), as a Measure of Extent of Exposure | From the first day to the last day of treatment (average of 8 weeks) | Time on study treatment, as a measure of extent of exposure, was assessed in all participants who received pazopanib. Time on study treatment was not measured in participants receiving pemetrexed. For these participants, extent of exposure was measured as the mean number of dosing cycles and dose intensity. See the outcome measures entitled "Mean number of dosing cycles, as a measure of extent of exposure" and "Average dose of pemetrexed for all cycles, as a measure of extent of exposure," respectively, for pemetrexed data. |
| Secondary | Mean Daily Dose, as a Measure of Extent of Exposure | From the first day to the last day of treatment (average of 8 weeks) | Mean daily dose, as a measure of extent of exposure, was assessed in all participants who received pazopanib. Mean daily dose was not measured in participants receiving pemetrexed. For these participants, extent of exposure was measured as the mean number of dosing cycles and dose intensity. See the outcome measures entitled "Mean number of dosing cycles, as a measure of extent of exposure" and "Average dose of pemetrexed for all cycles, as a measure of extent of exposure," respectively, for pemetrexed data. |
| Secondary | Mean Number of Pemetrexed Dosing Cycles, as a Measure of Extent of Exposure | From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks) | Duration of therapy/time on study treatment, measured as the mean number of pemetrexed dosing cycles as a measure of extent of exposure, was assessed in all participants who received pemetrexed. The mean number of dosing cycles was not measured in participants receiving pazopanib. For these participants, extent of exposure was measured as the time on study treatment and mean daily dose. See the outcome measures entitled "Time on study treatment (pazopanib), as a measure of extent of exposure" and "Mean daily dose, as a measure of extent of exposure," respectively, for pazopanib data. |
| Secondary | Average Dose of Pemetrexed for All Cycles, as a Measure of Extent of Exposure | From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks) | The average dose of pemetrexed for all cycles, as a measure of extent of exposure, was assessed in all participants who received pemetrexed. The average dose was not measured in participants receiving pazopanib. For these participants, extent of exposure was measured as the time on study treatment and mean daily dose. See the outcome measures entitled "Time on study treatment (pazopanib), as a measure of extent of exposure" and "Mean daily dose, as a measure of extent of exposure," respectively, for pazopanib data. |
| Secondary | Number of Participants With Any AE (Serious or Non-serious) Leading to Withdrawal From Study Treatment | From the time the first dose of study treatment was administered until withdrawal from study treatment (up to Study Week 55) | An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. A participant cold have been withdrawn fom study treatment due to an SAE or AE. |
| Secondary | Number of Participants With Any On-therapy AE (Serious or Non-serious) Leading to Dose Reductions (DRs) or Interruptions/Delays in the Study | From the time the first dose of study treatment was administered until discontinuation of treatment (up to Study Week 55) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs/SAEs. Management of AEs may require DRs/interruptions in study treatment. If necessary, the pazopanib dose should be reduced stepwise by 200 mg at each step. DRs for pemetrexed were 50-75% of prior dose based on the toxicity leading to DR. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | From randomization until the first documented sign of investigator-assessed disease progression or death, whichever occurred first (average of 10 study weeks) | Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered | weeks | MEDIAN |
| SECONDARY | Overall Survival | From randomization until disease progression or death (up to Study Week 78) | The study size (20 participants) and follow up were not adequate to assess overall survival. Participants who had not died at the time of the cut-off for the analysis were to be censored at the date the particpant was last known to be alive. | ||
| SECONDARY | Number of Participants (Par.) With the Indicated Best Overall Response | From randomization until the time of the first documented evidence of a confirmed complete response (CR) or partial response (PR) (average of 10 weeks) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Any Non-serious On-therapy Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) and Serious Adverse Event (SAE) | From the time the first dose of study treatment was administered until 28 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (up to Study Week 55) | Safety Population: all participants who were randomized and took at least one dose of study medication. This population was based on the actual treatment received, if it differed from that to which the participant was randomized. | participants | NUMBER |
| SECONDARY | Time on Study Treatment (Pazopanib), as a Measure of Extent of Exposure | From the first day to the last day of treatment (average of 8 weeks) | Safety Population | months | MEAN |
| SECONDARY | Mean Daily Dose, as a Measure of Extent of Exposure | From the first day to the last day of treatment (average of 8 weeks) | Safety Population | milligrams | MEAN |
| SECONDARY | Mean Number of Pemetrexed Dosing Cycles, as a Measure of Extent of Exposure | From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks) | Safety Population | number of cycles | MEAN |
| SECONDARY | Average Dose of Pemetrexed for All Cycles, as a Measure of Extent of Exposure | From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks) | Safety Population | milligrams per meters squared (m^2) | MEAN |
| SECONDARY | Number of Participants With Any AE (Serious or Non-serious) Leading to Withdrawal From Study Treatment | From the time the first dose of study treatment was administered until withdrawal from study treatment (up to Study Week 55) | Safety Population | participants | NUMBER |
| SECONDARY | Number of Participants With Any On-therapy AE (Serious or Non-serious) Leading to Dose Reductions (DRs) or Interruptions/Delays in the Study | From the time the first dose of study treatment was administered until discontinuation of treatment (up to Study Week 55) | Safety Population | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Pemetrexed 500 mg/m^2 | 10.3 | 90% Confidence Interval 5.3 to NA | weeks | |
| Progression Free Survival (PFS) | Pazopanib 800 mg | 12.7 | 90% Confidence Interval 6.0 to NA | weeks | |
| Number of Participants (Par.) With the Indicated Best Overall Response | Pemetrexed 500 mg/m^2 | CR | 0 | participants | |
| Number of Participants (Par.) With the Indicated Best Overall Response | Pazopanib 800 mg | CR | 0 | participants | |
| Number of Participants (Par.) With the Indicated Best Overall Response | Pemetrexed 500 mg/m^2 | PR | 0 | participants | |
| Number of Participants (Par.) With the Indicated Best Overall Response | Pazopanib 800 mg | PR | 0 | participants | |
| Number of Participants (Par.) With the Indicated Best Overall Response | Pemetrexed 500 mg/m^2 | SD | 2 | participants | |
| Number of Participants (Par.) With the Indicated Best Overall Response | Pazopanib 800 mg | SD | 2 | participants | |
| Number of Participants (Par.) With the Indicated Best Overall Response | Pemetrexed 500 mg/m^2 | PD | 4 | participants | |
| Number of Participants (Par.) With the Indicated Best Overall Response | Pazopanib 800 mg | PD | 4 | participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pemetrexed 500 mg/m^2 | 9 | |
| Overall Study | STARTED | Pazopanib 800 mg | 11 | |
| Overall Study | COMPLETED | Pemetrexed 500 mg/m^2 | 5 | |
| Overall Study | COMPLETED | Pazopanib 800 mg | 3 | |
| Overall Study | NOT COMPLETED | Pemetrexed 500 mg/m^2 | 4 | |
| Overall Study | NOT COMPLETED | Pazopanib 800 mg | 8 |
Source ClinicalTrials.gov
Adverse events186
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Pemetrexed 500 mg/m^2 | 3 | 9 | |
| other | Fatigue | General disorders | Pazopanib 800 mg | 3 | 10 | |
| other | Nausea | Gastrointestinal disorders | Pemetrexed 500 mg/m^2 | 2 | 9 | |
| other | Nausea | Gastrointestinal disorders | Pazopanib 800 mg | 3 | 10 | |
| other | Alanine aminotransferase increased | Investigations | Pemetrexed 500 mg/m^2 | 0 | 9 | |
| other | Alanine aminotransferase increased | Investigations | Pazopanib 800 mg | 3 | 10 | |
| other | Aspartate aminotransferase increased | Investigations | Pemetrexed 500 mg/m^2 | 0 | 9 | |
| other | Aspartate aminotransferase increased | Investigations | Pazopanib 800 mg | 3 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Pemetrexed 500 mg/m^2 | 0 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | Pazopanib 800 mg | 3 | 10 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pemetrexed 500 mg/m^2 | ||
| Total, all-cause mortality | Pazopanib 800 mg | ||
| Total, other adverse events | Pemetrexed 500 mg/m^2 | 9 | 9 |
| Total, other adverse events | Pazopanib 800 mg | 9 | 10 |
| Total, serious adverse events | Pemetrexed 500 mg/m^2 | 2 | 9 |
| Total, serious adverse events | Pazopanib 800 mg | 2 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pemetrexed 500 mg/m^2 vs Pazopanib 800 mg: Number of Participants With a Increase From Baseline in Bazett's QTc at the Indicated Time Points | Trial comparisons |
| Pemetrexed 500 mg/m^2 vs Pazopanib 800 mg: Number of Participants With Any AE (Serious or Non-serious) Leading to Withdrawal From Study Treatment | Trial comparisons |
| Pemetrexed 500 mg/m^2 vs Pazopanib 800 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01313663
GET https://conductscience.org/api/trials/v1/NCT01313663/results?page=2