Trial · NCT02795819
Study of the Pan-DAC Inhibitor AR-42 and Pazopanib in Advanced Sarcoma and Kidney Cancer
NCT02795819, Phase 1, Terminated, Virginia Commonwealth University; results first posted 2019-10-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Pan-DAC Inhibitor AR-42 and Pazopanib in Advanced Sarcoma and Kidney Cancer. Trials, record NCT02795819. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02795819
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Pan-DAC Inhibitor AR-42 and Pazopanib in Advanced Sarcoma and Kidney Cancer
- NCT number
- NCT02795819
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Renal Cell Carcinoma, Soft Tissue Sarcoma, Metastatic Disease
- Interventions
- AR-42, Pazopanib
- First posted
- 2016-06-10
- Last updated
- 2019-10-24
- Results first posted
- 2019-10-24
- Limitations and caveats
- Incomplete objectives due to early termination of trial.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Recommended Phase 2 Doses (RP2Ds) of AR-42 and Pazopanib When Given in Combination. | 1 month | To determine the recommended phase 2 doses (RP2Ds) for AR-42 and pazopanib that are the same as or less than the maximum tolerated doses (MTDs). The dose-limiting toxicity (DLT) evaluation period will be the first treatment cycle. Patients must have taken a minimum of 6 AR-42 doses and a minimum of 21 pazopanib doses during cycle 1 to be considered evaluable for DLT, if DLT has not been observed at the delivered dose. Patients' treatment dose level, dose modification, evaluability for DLT, and DLTs will be listed and summarized by basic descriptive statistics such as frequency and proportion. The maximum tolerated dose(MTDs)/recommended phase 2 doses (RP2Ds) will be found based on the criteria in the protocol. |
| Secondary | Number of Participants With Adverse Events That Were Related to Treatment, AR-42 and Pazopanib Combination. | 5 months | The safety and toxicity of AR-42 and pazopanib when given in combination. Adverse Events (AEs) were characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) to determine the safety and toxicity of the combination of AR-42 and pazopanib. All AEs regardless of grade were recorded from the beginning of the study procedures through 30 days following the end of study treatment. |
| Secondary | The Antitumor Effects of the AR-42 and Pazopanib Treatment Regimen in Patients With Advanced Renal Cell Carcinoma (RCC) or Soft Tissue Sarcoma (STS). | 5 months | Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Recommended Phase 2 Doses (RP2Ds) of AR-42 and Pazopanib When Given in Combination. | 1 month | Incomplete objective. No maximum tolerated dose (MTD) nor recommended phase two dose (RP2D) identified. Two dose limiting toxicities observed in 6 patients treated at the first dose level. Study terminated prior to exploration of additional dose levels. | Dose Limiting Toxicities | COUNT_OF_UNITS |
| SECONDARY | Number of Participants With Adverse Events That Were Related to Treatment, AR-42 and Pazopanib Combination. | 5 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Antitumor Effects of the AR-42 and Pazopanib Treatment Regimen in Patients With Advanced Renal Cell Carcinoma (RCC) or Soft Tissue Sarcoma (STS). | 5 months | Of 6 patients treated at dose level 1, 4 were evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Recommended Phase 2 Doses (RP2Ds) of AR-42 and Pazopanib When Given in Combination. | Cohort Minus 1 (-1) | 0 | Dose Limiting Toxicities | ||
| The Recommended Phase 2 Doses (RP2Ds) of AR-42 and Pazopanib When Given in Combination. | Cohort 1 | 2 | Dose Limiting Toxicities | ||
| The Recommended Phase 2 Doses (RP2Ds) of AR-42 and Pazopanib When Given in Combination. | Cohort 2 | 0 | Dose Limiting Toxicities | ||
| The Recommended Phase 2 Doses (RP2Ds) of AR-42 and Pazopanib When Given in Combination. | Cohort 3A | 0 | Dose Limiting Toxicities | ||
| The Recommended Phase 2 Doses (RP2Ds) of AR-42 and Pazopanib When Given in Combination. | Cohort 3B | 0 | Dose Limiting Toxicities | ||
| The Recommended Phase 2 Doses (RP2Ds) of AR-42 and Pazopanib When Given in Combination. | Cohort 4A | 0 | Dose Limiting Toxicities | ||
| The Recommended Phase 2 Doses (RP2Ds) of AR-42 and Pazopanib When Given in Combination. | Cohort 4B | 0 | Dose Limiting Toxicities | ||
| Number of Participants With Adverse Events That Were Related to Treatment, AR-42 and Pazopanib Combination. | Cohort Minus 1 (-1) | 0 | Participants | ||
| Number of Participants With Adverse Events That Were Related to Treatment, AR-42 and Pazopanib Combination. | Cohort 1 | 6 | Participants | ||
| Number of Participants With Adverse Events That Were Related to Treatment, AR-42 and Pazopanib Combination. | Cohort 2 | 0 | Participants |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort Minus 1 (-1) | 0 | |
| Overall Study | STARTED | Cohort 1 | 6 | |
| Overall Study | STARTED | Cohort 2 | 0 | |
| Overall Study | STARTED | Cohort 3A | 0 | |
| Overall Study | STARTED | Cohort 3B | 0 | |
| Overall Study | STARTED | Cohort 4A | 0 | |
| Overall Study | STARTED | Cohort 4B | 0 | |
| Overall Study | COMPLETED | Cohort Minus 1 (-1) | 0 | |
| Overall Study | COMPLETED | Cohort 1 | 6 | |
| Overall Study | COMPLETED | Cohort 2 | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events141
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 | Cohort 1 | 3 | 6 | 4 |
| other | Lymph node pain | Blood and lymphatic system disorders | Cohort 1 | 1 | 6 | 1 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Cohort 1 | 1 | 6 | 3 |
| other | Sinus bradycardia | Cardiac disorders | Cohort 1 | 1 | 6 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Cohort 1 | 3 | 6 | 6 |
| other | Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | Cohort 1 | 1 | 6 | 1 |
| other | Dry eye | Eye disorders | Cohort 1 | 1 | 6 | 1 |
| other | Eye pain | Eye disorders | Cohort 1 | 1 | 6 | 1 |
| other | Photophobia | Eye disorders | Cohort 1 | 1 | 6 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1 | 4 | 6 | 8 |
1 to 10 of 141Source ClinicalTrials.gov
See all 141 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 1 | 6 |
| Total, other adverse events | Cohort 1 | 6 | 6 |
| Total, serious adverse events | Cohort 1 | 2 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016059 | Massey Cancer Center - Cancer Center Support Grant | WINN, ROBERT A. | VIRGINIA COMMONWEALTH UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT02795819
GET https://conductscience.org/api/trials/v1/NCT02795819/results?page=2