Trial · NCT01498458
Pazopanib in Combination With Capecitabine in Patients With Metastatic Breast Cancer
NCT01498458, Phase 1, Completed, GBG Forschungs GmbH; results first posted 2014-09-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pazopanib in Combination With Capecitabine in Patients With Metastatic Breast Cancer. Trials, record NCT01498458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01498458
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib in Combination With Capecitabine in Patients With Metastatic Breast Cancer
- NCT number
- NCT01498458
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- GBG Forschungs GmbH
- Conditions
- Metastatic Breast Cancer
- Interventions
- Pazopanib plus capecitabine
- First posted
- 2011-12-23
- Last updated
- 2022-06-10
- Other registries' IDs
- eudract:2010-019510-25
- Results first posted
- 2014-09-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerable Dose (MTD) of Pazopanib | 3 years | The maximum tolerated dose (MTD) is defined as the highest dose level with DLT in no more than 1 out of 6 patients. A maximal tolerated dose (MTD) could not be established. |
| Secondary | Dose-limiting Toxicity (DLT) | 3 years | |
| Secondary | Hematological Toxicity of the Combination of Pazopanib and Capecitabine | 3 years | |
| Secondary | Other Toxicity of the Combination of Pazopanib and Capecitabine | 3 years | |
| Secondary | Objective Response Rate (ORR) | 3 years | To determine the objective response rate (ORR) in patients with measurable disease. ORR consists of complete response and partial response according to the RECIST criteria. Complete Response refers to the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to less than 10 mm. Partial Response refers to an at least 30 percent decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Clinical Benefit Rate (CBR) | 3 years | To determine the clinical benefit rate (CBR) in patients with measurable disease. CBR consists of complete response , partial response, and stable disease lasting greater than 24 weeks. All patients are included when determining this rate. 2 patients were on study treatment for a long time.Hence the outcome rate of 25 percent ( 2 from 8 patients) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerable Dose (MTD) of Pazopanib | 3 years | mg | NUMBER | |
| SECONDARY | Dose-limiting Toxicity (DLT) | 3 years | participants | NUMBER | |
| SECONDARY | Hematological Toxicity of the Combination of Pazopanib and Capecitabine | 3 years | Number of cycles | NUMBER | |
| SECONDARY | Other Toxicity of the Combination of Pazopanib and Capecitabine | 3 years | 6 patients experience 6 Serious Adverse Reactions | participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) | 3 years | All patients are included when determining this rate. | percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) | 3 years | All patients are included when determining this rate. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerable Dose (MTD) of Pazopanib | Pazopanib Plus Capecitabine | NA | mg | ||
| Dose-limiting Toxicity (DLT) | Pazopanib Plus Capecitabine | 5 | participants | ||
| Hematological Toxicity of the Combination of Pazopanib and Capecitabine | Pazopanib + Capecitabine | Anemia Grade 1 to 4 | 88 | Number of cycles | |
| Hematological Toxicity of the Combination of Pazopanib and Capecitabine | Pazopanib + Capecitabine | Leucopenia Grade 1 to 4 | 55 | Number of cycles | |
| Hematological Toxicity of the Combination of Pazopanib and Capecitabine | Pazopanib + Capecitabine | Number of Cycles | 132 | Number of cycles | |
| Other Toxicity of the Combination of Pazopanib and Capecitabine | Pazopanib Plus Capecitabine | Hepatotoxicity | 3 | participants | |
| Other Toxicity of the Combination of Pazopanib and Capecitabine | Pazopanib Plus Capecitabine | Hypertension | 1 | participants | |
| Other Toxicity of the Combination of Pazopanib and Capecitabine | Pazopanib Plus Capecitabine | Pancreatectomy | 1 | participants | |
| Other Toxicity of the Combination of Pazopanib and Capecitabine | Pazopanib Plus Capecitabine | Thrombocytopenia | 1 | participants | |
| Objective Response Rate (ORR) | Pazopanib Plus Capecitabine | 0 | percentage of participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pazopanib Plus Capecitabine | 8 | |
| Overall Study | COMPLETED | Pazopanib Plus Capecitabine | 1 | |
| Overall Study | NOT COMPLETED | Pazopanib Plus Capecitabine | 7 |
Source ClinicalTrials.gov
Adverse events15
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 | Pazopanib Plus Capecitabine | 8 | 8 | |
| other | anemia | Blood and lymphatic system disorders | Pazopanib Plus Capecitabine | 8 | 8 | |
| other | Neutropenia | Blood and lymphatic system disorders | Pazopanib Plus Capecitabine | 4 | 8 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pazopanib Plus Capecitabine | 7 | 8 | |
| other | alkaline Phosphatase | Hepatobiliary disorders | Pazopanib Plus Capecitabine | 2 | 8 | |
| other | ASAT | Hepatobiliary disorders | Pazopanib Plus Capecitabine | 7 | 8 | |
| other | Bilirubinaemia | Hepatobiliary disorders | Pazopanib Plus Capecitabine | 3 | 8 | |
| other | Fatigue CTC grade 3 | General disorders | Pazopanib Plus Capecitabine | 1 | 8 | 1 |
| other | Nausea CTC grade 3 | Gastrointestinal disorders | Pazopanib Plus Capecitabine | 1 | 8 | 1 |
| other | Mucositis CTC grade 3 | Gastrointestinal disorders | Pazopanib Plus Capecitabine | 1 | 8 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pazopanib Plus Capecitabine | ||
| Total, other adverse events | Pazopanib Plus Capecitabine | 8 | 8 |
| Total, serious adverse events | Pazopanib Plus Capecitabine | 6 | 8 |
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/NCT01498458
GET https://conductscience.org/api/trials/v1/NCT01498458/registered