Trial · NCT01253369
Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer
NCT01253369, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2016-01-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer. Trials, record NCT01253369. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01253369
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer
- NCT number
- NCT01253369
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Small Cell Lung Cancer, Lung Cancer, SCLC
- Interventions
- Pazopanib
- First posted
- 2010-12-03
- Last updated
- 2019-04-23
- Results first posted
- 2016-01-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 8-Week Progression-Free Rate | For this endpoint, disease was evaluated radiologically at baseline and week 8 on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20). | The 8-week progression free rate (PFR) was defined as achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions. |
| Secondary | Objective Response Rate | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20). | The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better objective response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 8-Week Progression-Free Rate | For this endpoint, disease was evaluated radiologically at baseline and week 8 on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20). | The analysis dataset is comprised of evaluable patients. Patients who had measurable disease at baseline, received at least 1 cycle of therapy and had their disease re-evaluated were considered evaluable for response. | proportion of patients | NUMBER |
| SECONDARY | Objective Response Rate | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20). | The analysis dataset is comprised of evaluable patients. Patients who had measurable disease at baseline, received at least 1 cycle of therapy and had their disease re-evaluated were considered evaluable for response. | proportion of patients | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 8-Week Progression-Free Rate | Pazopanib | 0.567 | 80% Confidence Interval 0.434 to 0.692 | proportion of patients | |
| Objective Response Rate | Pazopanib | 0.033 | 80% Confidence Interval 0.004 to 0.124 | proportion of patients |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pazopanib | 33 | |
| Overall Study | Evaluable | Pazopanib | 30 | |
| Overall Study | COMPLETED | Pazopanib | 0 | |
| Overall Study | NOT COMPLETED | Pazopanib | 33 |
Source ClinicalTrials.gov
Adverse events71
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 | Anemia | Blood and lymphatic system disorders | Pazopanib | 3 | 33 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Pazopanib | 5 | 33 | |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Pazopanib | 6 | 33 | |
| other | Supraventricular tachycardia | Cardiac disorders | Pazopanib | 2 | 33 | |
| other | Endocrine disorders - Other, specify | Endocrine disorders | Pazopanib | 1 | 33 | |
| other | Hypothyroidism | Endocrine disorders | Pazopanib | 3 | 33 | |
| other | Watering eyes | Eye disorders | Pazopanib | 1 | 33 | |
| other | Abdominal pain | Gastrointestinal disorders | Pazopanib | 4 | 33 | |
| other | Constipation | Gastrointestinal disorders | Pazopanib | 2 | 33 | |
| other | Diarrhea | Gastrointestinal disorders | Pazopanib | 15 | 33 |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pazopanib | ||
| Total, other adverse events | Pazopanib | 26 | 33 |
| Total, serious adverse events | Pazopanib | 12 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01253369
GET https://conductscience.org/api/trials/v1/NCT01253369/events?page=2