Trial · NCT01543763
Pazopanib in Combination With PCI-24781 in Patients With Metastatic Solid Tumors
NCT01543763, Phase 1, Completed, Pamela Munster
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pazopanib in Combination With PCI-24781 in Patients With Metastatic Solid Tumors. Trials, record NCT01543763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01543763
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib in Combination With PCI-24781 in Patients With Metastatic Solid Tumors
- NCT number
- NCT01543763
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 90 participants, actual
- Lead sponsor
- Pamela Munster
- Conditions
- Metastatic Solid Tumors
- Interventions
- PZP115891, PCI-24781
- First posted
- 2012-03-05
- Last updated
- 2025-03-21
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicity (DLT) | up to 4 weeks | A dose limiting toxicity (DLT) will be defined as any predetermined adverse events occurring during Cycle 1 when association to therapy that is part of this study is related or possibly related |
| Primary | Maximum Tolerated Dose (MTD) | up to 4 weeks | The maximum tolerated dose (MTD) will be defined as the highest tested dose level at which less than 33% of patients experience DLT in Cycle 1 |
| Secondary | Establish the volume of distribution of PCI-24781, pazopanib and the combination of the two drugs. | up to 2 months | Noncompartmental pharmacokinetic profile of PCI-24781, pazopanib and the combination will be assessed by measuring and calculating the volume of distribution (Vd) |
| Secondary | Establish the bioavailability of PCI-24781, pazopanib and the combination of the two drugs. | up to 2 months | Noncompartmental pharmacokinetic profile of PCI-24781, pazopanib and the combination will be assessed by measuring and calculating the bioavailability (F). |
| Secondary | Establish the clearance of PCI-24781, pazopanib and the combination of the two drugs. | up to 2 months | Noncompartmental pharmacokinetic profile of PCI-24781, pazopanib and the combination will be assessed by measuring and calculating clearance (CL) |
| Secondary | Establish the half-life of PCI-24781, pazopanib and the combination of the two drugs. | up to 2 months | Noncompartmental pharmacokinetic profile of PCI-24781, pazopanib and the combination will be assessed by measuring and calculating the half-life (t1/2) |
| Secondary | Establish the area under the curve (AUC) of PCI-24781, pazopanib and the combination of the two drugs. | up to 2 months | Noncompartmental pharmacokinetic profile of PCI-24781, pazopanib and the combination will be assessed by measuring and calculating the AUC |
| Secondary | Clinical Benefit Rate (CBR) | approximately 4 months | Clinical Benefit Rate=Complete Response (CR)+Partial Response (PR)+Stable Disease (SD) is defined as the best response at any time or maintaining stable disease for at least 12 weeks and will be evaluated by imaging criteria RECIST 1.1. A patient with unknown or missing response will be treated as a non-responder. Patients are expected to receive treatment for at least 2 Cycles, at which time the first evaluation for efficacy will occur. Exact methods for calculated confidence intervals will be utilized. |
| Secondary | Objective response rate (ORR) | approximately 4 months | Objective response rate is defined as the percentage or proportion of patients with a confirmed complete or partial response (CR+PR) as defined by RECIST 1.1 divided by the total number of patients on study. Patients are expected to receive treatment for at least 2 Cycles, at which time the first evaluation for efficacy will occur. A patient with unknown or missing response will be treated as a non-responder. Exact methods for calculated confidence intervals will be utilized. |
| Secondary | Progression-free Survival (PFS) | Up to 1 year | Time to progression will be calculated as the time from first dose of the combination until the earliest date of documented disease relapse, progression, or death from any cause. If the patient does not have a documented date of progression or death, then PFS will be censored at the date of last adequate assessment. PFS will be summarized using Kaplan-Meier method and lifetables, including the 1-year point estimates with standard errors. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39509670 | DERIVED |
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 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/NCT01543763
GET https://conductscience.org/api/trials/v1/NCT01543763/registered