Trial · NCT01376310
GSK1120212 Rollover Study
NCT01376310, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2019-02-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GSK1120212 Rollover Study. Trials, record NCT01376310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01376310
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GSK1120212 Rollover Study
- NCT number
- NCT01376310
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 159 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cancer
- Interventions
- GSK1120212, Docetaxel + GSK1120212, Erlotinib + GSK1120212, Pemetrexed + GSK1120212, Carboplatin + GSK1120212, Nab-paclitaxel + GSK1120212, Gemcitabine + GSK1120212, Everolimus + GSK1120212
- First posted
- 2011-06-20
- Last updated
- 2019-02-19
- Results first posted
- 2019-02-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Until 30 days after the last dose of study treatment. Subjects may have continued to receive study treatment until disease progression, death, unacceptable toxicity or until locally commercially available. The maximum duration of exposure was 76 months. | Number of participants with adverse events as a measure of safety and tolerability |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events | Until 30 days after the last dose of study treatment. Subjects may have continued to receive study treatment until disease progression, death, unacceptable toxicity or until locally commercially available. The maximum duration of exposure was 76 months. | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Cohort A (GSK1120212 < 24 Weeks) | Adverse Events | 119 | Participants | |
| Number of Participants With Adverse Events | Cohort B (GSK1120212 >= 24 Weeks) | Adverse Events | 30 | Participants | |
| Number of Participants With Adverse Events | Cohort A (GSK1120212 < 24 Weeks) | Treatment-Related Adverse Events | 101 | Participants | |
| Number of Participants With Adverse Events | Cohort B (GSK1120212 >= 24 Weeks) | Treatment-Related Adverse Events | 26 | Participants | |
| Number of Participants With Adverse Events | Cohort A (GSK1120212 < 24 Weeks) | Serious Adverse Events | 26 | Participants | |
| Number of Participants With Adverse Events | Cohort B (GSK1120212 >= 24 Weeks) | Serious Adverse Events | 13 | Participants | |
| Number of Participants With Adverse Events | Cohort A (GSK1120212 < 24 Weeks) | Treatment-Related Serious Adverse Events | 8 | Participants | |
| Number of Participants With Adverse Events | Cohort B (GSK1120212 >= 24 Weeks) | Treatment-Related Serious Adverse Events | 4 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A (GSK1120212 < 24 Weeks) | 126 | |
| Overall Study | STARTED | Cohort B (GSK1120212 >= 24 Weeks) | 33 | |
| Overall Study | COMPLETED | Cohort A (GSK1120212 < 24 Weeks) | 90 | |
| Overall Study | COMPLETED | Cohort B (GSK1120212 >= 24 Weeks) | 22 | |
| Overall Study | NOT COMPLETED | Cohort A (GSK1120212 < 24 Weeks) | 36 | |
| Overall Study | NOT COMPLETED | Cohort B (GSK1120212 >= 24 Weeks) | 11 |
Source ClinicalTrials.gov
Adverse events234
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 | Anaemia | Blood and lymphatic system disorders | Cohort A (GSK1120212 < 24 Weeks) | 15 | 126 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B (GSK1120212 >= 24 Weeks) | 3 | 33 | |
| other | Vertigo | Ear and labyrinth disorders | Cohort A (GSK1120212 < 24 Weeks) | 0 | 126 | |
| other | Vertigo | Ear and labyrinth disorders | Cohort B (GSK1120212 >= 24 Weeks) | 2 | 33 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort A (GSK1120212 < 24 Weeks) | 6 | 126 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort B (GSK1120212 >= 24 Weeks) | 5 | 33 | |
| other | Ascites | Gastrointestinal disorders | Cohort A (GSK1120212 < 24 Weeks) | 5 | 126 | |
| other | Ascites | Gastrointestinal disorders | Cohort B (GSK1120212 >= 24 Weeks) | 2 | 33 | |
| other | Constipation | Gastrointestinal disorders | Cohort A (GSK1120212 < 24 Weeks) | 14 | 126 | |
| other | Constipation | Gastrointestinal disorders | Cohort B (GSK1120212 >= 24 Weeks) | 7 | 33 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A (GSK1120212 < 24 Weeks) | 13 | 126 |
| Total, all-cause mortality | Cohort B (GSK1120212 >= 24 Weeks) | 3 | 33 |
| Total, other adverse events | Cohort A (GSK1120212 < 24 Weeks) | 115 | 126 |
| Total, other adverse events | Cohort B (GSK1120212 >= 24 Weeks) | 28 | 33 |
| Total, serious adverse events | Cohort A (GSK1120212 < 24 Weeks) | 26 | 126 |
| Total, serious adverse events | Cohort B (GSK1120212 >= 24 Weeks) | 13 | 33 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A (GSK1120212 < 24 Weeks) vs Cohort B (GSK1120212 >= 24 Weeks): deaths from any cause | Trial comparisons |
| Cohort A (GSK1120212 < 24 Weeks) vs Cohort B (GSK1120212 >= 24 Weeks): 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/NCT01376310
GET https://conductscience.org/api/trials/v1/NCT01376310/events?page=2