Trial · NCT01184326
Expanded Phase I Pazopanib and Everolimus in Advanced Solid Tumors and Previously Treated Advanced Urothelial Cancer
NCT01184326, Phase 1, Completed, Dana-Farber Cancer Institute; results first posted 2018-11-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Expanded Phase I Pazopanib and Everolimus in Advanced Solid Tumors and Previously Treated Advanced Urothelial Cancer. Trials, record NCT01184326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01184326
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Expanded Phase I Pazopanib and Everolimus in Advanced Solid Tumors and Previously Treated Advanced Urothelial Cancer
- NCT number
- NCT01184326
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 23 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Solid Tumor, Kidney Cancer
- Interventions
- pazopanib, everolimus
- First posted
- 2010-08-18
- Last updated
- 2019-10-02
- Results first posted
- 2018-11-23
- Limitations and caveats
- The phase 1 expansion cohort was terminated early due to weak accrual.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) [Phase I Dose Finding] | Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; The observation period for MTD evaluation was the first 28 days of treatment. | The MTD of Pazopanib in combination with Everolimus 5 mg PO QD was determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. |
| Primary | Dose Limiting Toxicity (DLT) [Phase I Dose Finding] | Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; The observation period for DLT evaluation was the first 28 days of treatment. | A DLT was defined as an adverse event (a) with treatment attribution of possible, probable, or definite, and (b) occurs during cycle 1, and (c) meets any of the following criteria: Grade 3 or 4 non-hematologic toxicity excluding: nausea/vomiting controlled with antiemetics, Grade 3 hypertension that resolves to ≤150/90 within 7 days with supportive care, and Grade 3 asymptomatic, clinically insignificant laboratory abnormalities (LDH, alkaline phosphatase due to bone metastases, and asymptomatic hypophosphatemia). Hematologic toxicity: Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding, Grade 4 neutropenia which persists for \>7 days, Grade 4 neutropenia associated with fever \>38.5C; Hematologic toxicity excluded lymphopenia or anemia of any grade. Missing more than 5 days of planned doses for drug-related intolerable grade 2 toxicity;Toxicity related to therapy severe enough to require a dose-reduction. |
| Primary | Objective Response Rate [Expansion] | TDisease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment duration was up to 6 cycles in the Dose Level 0 cohort, 14 cycles in the Dose Level -1 cohort and 10 cycles in the expansion cohort (1 cycle=28 days). | The objective response rate (ORR) was defined as the percentage of participants 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 overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Grade 4 Treatment-Related Toxicity Rate [Dose Finding] | Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; Treatment duration was up to 6 cycles in the Dose Level 0 cohort and 14 cycles in the Dose Level -1 cohort (1 cycle=28 days). | Grade 4 treatment-related toxicity rate is the percentage of participants experiencing at least one treatment-related grade 4 adverse event (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms. |
| Secondary | Median Progression-Free Survival [Expansion] | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; PFS follow-up was up to 9.2 months in the expansion cohort. | Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Participants alive without PD are censored at date of last disease assessment. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum longest diameter (LD), taking as reference the smallest sum on study with at least 5 mm absolute increase or the appearance of one or more new lesions. For non-target lesions, PD is appearance of one or more new lesions or unequivocal progression of existing non-target lesions. |
| Secondary | Mean Duration of Response [Expansion] | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; PFS follow-up was up to 9.2 months in the expansion cohort. | Duration of response was calculated as the time from achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment until disease progression. 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 overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. For target lesions: PD is at least a 20% increase in sum longest diameter (LD), taking as reference the smallest sum on study with at least 5 mm absolute increase or the appearance of one or more new lesions. For non-target lesions, PD is appearance of one or more new lesions or unequivocal progression of existing non-target lesions. |
| Secondary | Grade 4 Treatment-Related Toxicity Rate [Expansion] | Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; Treatment duration was up to 10 cycles in the expansion cohort (1 cycle=28 days). | Grade 4 treatment-related toxicity rate is the percentage of participants experiencing at least one treatment-related grade 4 adverse event (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) [Phase I Dose Finding] | Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; The observation period for MTD evaluation was the first 28 days of treatment. | All phase I dose finding participants who received at least one dose of the study drug were evaluable for MTD. | mg | NUMBER |
| PRIMARY | Dose Limiting Toxicity (DLT) [Phase I Dose Finding] | Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; The observation period for DLT evaluation was the first 28 days of treatment. | All phase I dose finding participants who received at least one dose of the study drug were evaluable for DLT. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Objective Response Rate [Expansion] | TDisease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment duration was up to 6 cycles in the Dose Level 0 cohort, 14 cycles in the Dose Level -1 cohort and 10 cycles in the expansion cohort (1 cycle=28 days). | The analysis population is comprised of all enrolled Phase 1 expansion participants. | percentage of participants | NUMBER |
| SECONDARY | Grade 4 Treatment-Related Toxicity Rate [Dose Finding] | Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; Treatment duration was up to 6 cycles in the Dose Level 0 cohort and 14 cycles in the Dose Level -1 cohort (1 cycle=28 days). | All phase I dose finding participants who received at least one dose of the study drug were evaluable for toxicity. | percentage of participants | NUMBER |
| SECONDARY | Median Progression-Free Survival [Expansion] | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; PFS follow-up was up to 9.2 months in the expansion cohort. | The analysis population is comprised of all enrolled Phase 1 expansion participants. | months | MEDIAN |
| SECONDARY | Mean Duration of Response [Expansion] | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; PFS follow-up was up to 9.2 months in the expansion cohort. | The duration of response is only estimated in the phase 1 expansion participants who achieved objective response on treatment. | months | MEAN |
| SECONDARY | Grade 4 Treatment-Related Toxicity Rate [Expansion] | Participants were assessed for adverse events on days 1 and 15 for cycles 1-2 and every cycle thereafter; Treatment duration was up to 10 cycles in the expansion cohort (1 cycle=28 days). | All phase I expansion participants who received at least one dose of the study drug were evaluable for toxicity. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) [Phase I Dose Finding] | All Phase I Dose Finding Participants | 400 | mg | ||
| Dose Limiting Toxicity (DLT) [Phase I Dose Finding] | Dose Level 0: Everolimus 5mg + Pazopanib 600 mg | 2 | Participants | ||
| Dose Limiting Toxicity (DLT) [Phase I Dose Finding] | Dose Level -1: Everolimus 5mg + Pazopanib 400 mg | 0 | Participants | ||
| Objective Response Rate [Expansion] | All Phase I Dose Expansion Participants | 21.4 | 95% Confidence Interval 4.7 to 50.8 | percentage of participants | |
| Grade 4 Treatment-Related Toxicity Rate [Dose Finding] | Dose Level 0: Everolimus 5mg + Pazopanib 600 mg [Dose Finding] | 33.3 | 95% Confidence Interval 0.9 to 90.6 | percentage of participants | |
| Grade 4 Treatment-Related Toxicity Rate [Dose Finding] | Dose Level -1: Everolimus 5mg + Pazopanib 400 mg [Dose Finding | 0.0 | 95% Confidence Interval 0.0 to 45.9 | percentage of participants | |
| Median Progression-Free Survival [Expansion] | All Phase I Dose Expansion Participants | 2.9 | 95% Confidence Interval 0.9 to 3.6 | months | |
| Mean Duration of Response [Expansion] | All Phase I Dose Expansion Participants | 4.9 | Full Range 1.7 to 7.4 | months | |
| Grade 4 Treatment-Related Toxicity Rate [Expansion] | All Phase I Dose Expansion Participants | 7.1 | 95% Confidence Interval 0.2 to 33.9 | percentage of participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 0: Everolimus 5mg + Pazopanib 600 mg | 3 | |
| Overall Study | STARTED | Dose Level -1: Everolimus 5mg + Pazopanib 400 mg | 6 | |
| Overall Study | STARTED | All Phase I Dose Expansion Participants | 14 | |
| Overall Study | COMPLETED | Dose Level 0: Everolimus 5mg + Pazopanib 600 mg | 0 | |
| Overall Study | COMPLETED | Dose Level -1: Everolimus 5mg + Pazopanib 400 mg | 0 | |
| Overall Study | COMPLETED | All Phase I Dose Expansion Participants | 0 | |
| Overall Study | NOT COMPLETED | Dose Level 0: Everolimus 5mg + Pazopanib 600 mg | 3 | |
| Overall Study | NOT COMPLETED | Dose Level -1: Everolimus 5mg + Pazopanib 400 mg | 6 | |
| Overall Study | NOT COMPLETED | All Phase I Dose Expansion Participants | 14 |
Source ClinicalTrials.gov
Adverse events318
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 | Abdominal pain | Gastrointestinal disorders | Dose Level 0: Everolimus 5mg + Pazopanib 600 mg | 0 | 3 | |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level -1: Everolimus 5mg + Pazopanib 400 mg | 2 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | All Phase I Dose Expansion Participants | 2 | 14 | |
| other | Alanine aminotransferase increased | Investigations | Dose Level 0: Everolimus 5mg + Pazopanib 600 mg | 1 | 3 | |
| other | Alanine aminotransferase increased | Investigations | Dose Level -1: Everolimus 5mg + Pazopanib 400 mg | 3 | 6 | |
| other | Alanine aminotransferase increased | Investigations | All Phase I Dose Expansion Participants | 4 | 14 | |
| other | Alkaline phosphatase increased | Investigations | Dose Level 0: Everolimus 5mg + Pazopanib 600 mg | 0 | 3 | |
| other | Alkaline phosphatase increased | Investigations | Dose Level -1: Everolimus 5mg + Pazopanib 400 mg | 1 | 6 | |
| other | Alkaline phosphatase increased | Investigations | All Phase I Dose Expansion Participants | 1 | 14 | |
| other | Anemia | Blood and lymphatic system disorders | Dose Level 0: Everolimus 5mg + Pazopanib 600 mg | 1 | 3 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 0: Everolimus 5mg + Pazopanib 600 mg | 3 | 3 |
| Total, all-cause mortality | Dose Level -1: Everolimus 5mg + Pazopanib 400 mg | 6 | 6 |
| Total, all-cause mortality | All Phase I Dose Expansion Participants | 9 | 14 |
| Total, other adverse events | Dose Level 0: Everolimus 5mg + Pazopanib 600 mg | 3 | 3 |
| Total, other adverse events | Dose Level -1: Everolimus 5mg + Pazopanib 400 mg | 6 | 6 |
| Total, other adverse events | All Phase I Dose Expansion Participants | 13 | 14 |
| Total, serious adverse events | Dose Level 0: Everolimus 5mg + Pazopanib 600 mg | 3 | 3 |
| Total, serious adverse events | Dose Level -1: Everolimus 5mg + Pazopanib 400 mg | 2 | 6 |
| Total, serious adverse events | All Phase I Dose Expansion Participants | 13 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30220708 | RESULT |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dose Level 0: Everolimus 5mg + Pazopanib 600 mg vs Dose Level -1: Everolimus 5mg + Pazopanib 400 mg: Dose Limiting Toxicity (DLT) [Phase I Dose Finding] |
Source 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/NCT01184326
GET https://conductscience.org/api/trials/v1/NCT01184326/events?page=2