Trial · NCT00430781
Pazopanib Plus Lapatinib Compared to Lapatinib Alone and Pazopanib Alone In Subjects With Metastatic Cervical Cancer
NCT00430781, Phase 2, Completed, GlaxoSmithKline; results first posted 2011-03-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pazopanib Plus Lapatinib Compared to Lapatinib Alone and Pazopanib Alone In Subjects With Metastatic Cervical Cancer. Trials, record NCT00430781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00430781
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib Plus Lapatinib Compared to Lapatinib Alone and Pazopanib Alone In Subjects With Metastatic Cervical Cancer
- NCT number
- NCT00430781
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 228 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Neoplasms, Uterine Cervix, Metastatic Cervical Cancer
- Interventions
- pazopanib (GW786034), lapatinib (GW572016)
- First posted
- 2007-02-02
- Last updated
- 2015-05-08
- Results first posted
- 2011-03-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) in Interim Analysis | From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks) | PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. The study was designed to test Combination vs. Lapatinib first. The result indicated that Combination would not show improvement over Lapatinib even if followed until the final analysis and the Combination arm was terminated. The monotherapy arms continued to the final analysis. Data shown here are from this interim analysis. |
| Primary | Progression-free Survival (PFS) in Final Analysis | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. This study began as a 3-arm study. The combination arm was terminated at the interim analysis. The monotherapy arms continued to final analysis. Data shown here are from the final analysis. |
| Secondary | Overall Survival | From Randomization (11 December 2006) until approximately 78% overall survival events at the time of the second overall survival update (3 March 2010) (up to 168.29 weeks) | Overall survival is defined as the time from randomization until death due to any cause. |
| Secondary | Clinical Benefit Response | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | Clinical benefit response is defined as the number of participants with evidence of complete (CR) or partial (PR) tumor response or stable disease (SD) for at least 6 months (183 days). Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Stable Disease, small changes that do not meet previously given criteria. Confirmation requires at least 2 assessments of CR/PR with at least 4 weeks between assessments. |
| Secondary | Response | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | Response is defined as the number of participants achieving either a complete or partial tumor response per RECIST criteria. CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum. |
| Secondary | Time to Response | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | For the subset of participants who showed a confirmed CR or PR, time to response was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum. |
| Secondary | Duration of Response | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | For participants who had a CR or PR, the duration of response was defined as the time from first documented evidence of PR or CR until the first documented sign of disease progression or death. CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum. |
| Secondary | Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib | From Randomization (11 December 2006) until last participant had last visit (28 July 2011) in combined population of two monotherapy arms (up to 241.43 weeks) | Safety was assessed as the number of participants experiencing a serious adverse event (SAE) or an adverse event (AE). See the adverse event module for safety data. |
Source ClinicalTrials.gov
Outcomes8
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) in Interim Analysis | From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks) | Intent to Treat (ITT) Population: all randomized participants | Weeks | MEDIAN |
| SECONDARY | Overall Survival | From Randomization (11 December 2006) until approximately 78% overall survival events at the time of the second overall survival update (3 March 2010) (up to 168.29 weeks) | ITT Population | Weeks | MEDIAN |
| SECONDARY | Clinical Benefit Response | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | ITT Population | participants | NUMBER |
| SECONDARY | Response | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | ITT Population | participants | NUMBER |
| SECONDARY | Time to Response | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | ITT Population | weeks | MEAN |
| SECONDARY | Duration of Response | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | ITT Population. The median for lapatinib was not reached at the time of data cut-off. No formal analysis of this endpoint was conducted for this group due to a very small number of responding participants. | weeks | MEAN |
| SECONDARY | Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib | From Randomization (11 December 2006) until last participant had last visit (28 July 2011) in combined population of two monotherapy arms (up to 241.43 weeks) | Safety Population: all participants who received at least one dose of study drug | participants | NUMBER |
| PRIMARY | Progression-free Survival (PFS) in Final Analysis | From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks) | ITT Population | Weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group20
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) in Interim Analysis | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | 12.6 | 90% Confidence Interval 11.7 to 14.1 | Weeks | |
| Progression-free Survival (PFS) in Interim Analysis | Lapatinib Monotherapy | 12.6 | 90% Confidence Interval 11.6 to 18.3 | Weeks | |
| Progression-free Survival (PFS) in Interim Analysis | Pazopanib Monotherapy | 17.9 | 90% Confidence Interval 12.1 to 23.9 | Weeks | |
| Overall Survival | Lapatinib Monotherapy | 44.1 | 90% Confidence Interval 35.6 to 48.9 | Weeks | |
| Overall Survival | Pazopanib Monotherapy | 49.7 | 90% Confidence Interval 42.0 to 55.9 | Weeks | |
| Clinical Benefit Response | Lapatinib Monotherapy | 7 | participants | ||
| Clinical Benefit Response | Pazopanib Monotherapy | 15 | participants | ||
| Response | Lapatinib Monotherapy | 4 | participants | ||
| Response | Pazopanib Monotherapy | 7 | participants | ||
| Time to Response | Lapatinib Monotherapy | 18.2 | 90% Confidence Interval 6.0 to 24.1 | weeks |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Interim Analysis; 11 February 2008 | STARTED | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | 59 | |
| Interim Analysis; 11 February 2008 | STARTED | Lapatinib Monotherapy | 58 | |
| Interim Analysis; 11 February 2008 | STARTED | Pazopanib Monotherapy | 60 | |
| Interim Analysis; 11 February 2008 | Ongoing | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | 23 | |
| Interim Analysis; 11 February 2008 | Ongoing | Lapatinib Monotherapy | 20 | |
| Interim Analysis; 11 February 2008 | Ongoing | Pazopanib Monotherapy | 25 | |
| Interim Analysis; 11 February 2008 | COMPLETED | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | 0 | |
| Interim Analysis; 11 February 2008 | COMPLETED | Lapatinib Monotherapy | 0 | |
| Interim Analysis; 11 February 2008 | COMPLETED | Pazopanib Monotherapy | 0 | |
| Interim Analysis; 11 February 2008 | NOT COMPLETED | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | 59 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events456
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 | Diarrhoea | Gastrointestinal disorders | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | 58 | 76 | |
| other | Diarrhoea | Gastrointestinal disorders | Lapatinib Monotherapy | 42 | 76 | |
| other | Diarrhoea | Gastrointestinal disorders | Pazopanib Monotherapy | 40 | 74 | |
| other | Nausea | Gastrointestinal disorders | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | 28 | 76 | |
| other | Nausea | Gastrointestinal disorders | Lapatinib Monotherapy | 25 | 76 | |
| other | Nausea | Gastrointestinal disorders | Pazopanib Monotherapy | 28 | 74 | |
| other | Vomiting | Gastrointestinal disorders | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | 32 | 76 | |
| other | Vomiting | Gastrointestinal disorders | Lapatinib Monotherapy | 18 | 76 | |
| other | Vomiting | Gastrointestinal disorders | Pazopanib Monotherapy | 15 | 74 | |
| other | Abdominal pain | Gastrointestinal disorders | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | 15 | 76 |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | ||
| Total, all-cause mortality | Lapatinib Monotherapy | ||
| Total, all-cause mortality | Pazopanib Monotherapy | ||
| Total, other adverse events | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | 71 | 76 |
| Total, other adverse events | Lapatinib Monotherapy | 66 | 76 |
| Total, other adverse events | Pazopanib Monotherapy | 69 | 74 |
| Total, serious adverse events | Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg | 32 | 76 |
| Total, serious adverse events | Lapatinib Monotherapy | 22 | 76 |
| Total, serious adverse events | Pazopanib Monotherapy | 28 | 74 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lapatinib Monotherapy vs Pazopanib Monotherapy: Clinical Benefit Response | Trial comparisons |
| Lapatinib Monotherapy vs Pazopanib Monotherapy: Response | 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.
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