Trial · NCT02030067
Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies
NCT02030067, Phase 1, Phase 2, Completed, Processa Pharmaceuticals; results first posted 2023-12-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies. Trials, record NCT02030067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02030067
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies
- NCT number
- NCT02030067
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 127 participants, actual
- Lead sponsor
- Processa Pharmaceuticals
- Conditions
- Solid Tumor, Metastatic Bladder Cancer
- Interventions
- RX-3117
- First posted
- 2014-01-08
- Last updated
- 2023-12-06
- Results first posted
- 2023-12-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 28 days | Number of subjects participating in Phase 1 that experienced a DLT during the first cycle of treatment (28 days) |
| Primary | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | through study completion, up to 224 days (8 cycles of treatment) | Number of subjects participating in Phase 1 that experience any SAEs |
| Primary | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | through study completion, up to 224 days (8 cycles of treatment) | Number of subjects participating in Phase 1 of study that discontinued study treatment due to a treatment emergent adverse event. |
| Primary | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | through study completion, up to 224 days (8 cycles of treatment) | Number of subjects that experience any treatment-related adverse event. |
| Primary | Progression Free Survival (Phase 2) | 4 months | Progression Free Survival in Phase 2 of the study for pancreatic and bladder cancer subjects. |
| Secondary | Area Under the Plasma Concentration Time Curve (AUC) (Phase 1) | Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours after oral administration in Cycle 1 Days 1 and 15 | |
| Secondary | Best Overall Response Rate (Phase 2) | Baseline and at 4, 8, 12, 16 and 32 weeks | Best Overall Response Rate (includes Complete Response, Partial Response, and Stable Disease) |
| Other | Biomarker Concentrations in Blood (Phase 1 and Phase 2) | Baseline and 4, 8, 12, 16 and 32 weeks | Analysis of biomarker data not conducted. Biomarker samples were not analyzed due to previous sponsor terminating clinical program. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | through study completion, up to 224 days (8 cycles of treatment) | Population includes those subjects participating in the dose escalation phase of the study (Phase 1) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | through study completion, up to 224 days (8 cycles of treatment) | Population includes subjects in the dose escalation phase of the study (Phase 1) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | through study completion, up to 224 days (8 cycles of treatment) | Population includes subjects participating in the dose escalation phase of the study (Phase 1) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression Free Survival (Phase 2) | 4 months | Patients participating in Phase 2 of the study, which included 41 pancreatic cancer and 31 bladder cancer patients | weeks | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration Time Curve (AUC) (Phase 1) | Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours after oral administration in Cycle 1 Days 1 and 15 | No pharmacokinetic analysis was conducted | ||
| SECONDARY | Best Overall Response Rate (Phase 2) | Baseline and at 4, 8, 12, 16 and 32 weeks | Evaluable for Tumor Response Analysis Set (includes Bladder and Pancreatic patients in Phase 2) | percentage | NUMBER |
| OTHER_PRE_SPECIFIED | Biomarker Concentrations in Blood (Phase 1 and Phase 2) | Baseline and 4, 8, 12, 16 and 32 weeks | Analysis of biomarker data not conducted. Biomarker samples were not analyzed due to previous sponsor terminating clinical program. |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | RX-3117 30 mg, 3 Times/Week | 0 | Participants | ||
| Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | RX-3117 60 mg, 3 Times/Week | 0 | Participants | ||
| Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | RX-3117 100 mg, 3 Times/Week | 0 | Participants | ||
| Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | RX-3117 150 mg, 3 Times/Week | 0 | Participants | ||
| Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | RX-3117 200 mg, 3 Times/Week | 0 | Participants | ||
| Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | RX-3117 500 mg, 3 Times/Week | 0 | Participants | ||
| Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | RX-3117 1000 mg, 3 Times/Week | 0 | Participants | ||
| Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | RX 3117 1500 mg, 3 Times/Week | 0 | Participants | ||
| Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | RX-3117 2000 mg, 3 Times/Week | 1 | Participants | ||
| Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | RX-3117 500 mg, 5 Times/Week | 0 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow39
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RX-3117 30 mg, 3 Times/Week | 1 | |
| Overall Study | STARTED | RX-3117 60 mg, 3 Times/Week | 1 | |
| Overall Study | STARTED | RX-3117 100 mg, 3 Times/Week | 3 | |
| Overall Study | STARTED | RX-3117 150 mg, 3 Times/Week | 3 | |
| Overall Study | STARTED | RX-3117 200 mg, 3 Times/Week | 3 | |
| Overall Study | STARTED | RX-3117 500 mg, 3 Times/Week | 3 | |
| Overall Study | STARTED | RX-3117 1000 mg, 3 Times/Week | 3 | |
| Overall Study | STARTED | RX 3117 1500 mg, 3 Times/Week | 4 | |
| Overall Study | STARTED | RX-3117 2000 mg, 3 Times/Week | 6 | |
| Overall Study | STARTED | RX-3117 500 mg, 5 Times/Week | 3 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 participant flowAdverse events1,118
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 | nausea | Gastrointestinal disorders | Phase 1 (Dose Escalation) 30 mg 3x/Week | 0 | 1 | |
| other | nausea | Gastrointestinal disorders | Phase 1 (Dose Escalation) 60 mg 3x/Week | 0 | 1 | |
| other | nausea | Gastrointestinal disorders | Phase 1 (Dose Escalation) 100 mg 3x/Week | 2 | 3 | |
| other | nausea | Gastrointestinal disorders | Phase 1 (Dose Escalation) 150 mg 3x/Week | 1 | 3 | |
| other | nausea | Gastrointestinal disorders | Phase 1 (Dose Escalation) 200 mg 3x/Week | 1 | 3 | |
| other | nausea | Gastrointestinal disorders | Phase 1 (Dose Escalation) 500 mg 3x/Week | 0 | 3 | |
| other | nausea | Gastrointestinal disorders | Phase 1 (Dose Escalation) 1000 mg 3x/Week | 1 | 3 | |
| other | nausea | Gastrointestinal disorders | Phase 1 (Dose Escalation) 1500 mg 3x/Week | 1 | 4 | |
| other | nausea | Gastrointestinal disorders | Phase 1 (Dose Escalation) 2000 mg 3x/Week | 2 | 6 | |
| other | nausea | Gastrointestinal disorders | Phase 1 (Dose Escalation) 500 mg 5x/Week | 0 | 3 |
1 to 10 of 1,118Source ClinicalTrials.gov
See all 1,118 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 (Dose Escalation) 30 mg 3x/Week | 0 | 1 |
| Total, all-cause mortality | Phase 1 (Dose Escalation) 60 mg 3x/Week | 0 | 1 |
| Total, all-cause mortality | Phase 1 (Dose Escalation) 100 mg 3x/Week | 0 | 3 |
| Total, all-cause mortality | Phase 1 (Dose Escalation) 150 mg 3x/Week | 0 | 3 |
| Total, all-cause mortality | Phase 1 (Dose Escalation) 200 mg 3x/Week | 0 | 3 |
| Total, all-cause mortality | Phase 1 (Dose Escalation) 500 mg 3x/Week | 0 | 3 |
| Total, all-cause mortality | Phase 1 (Dose Escalation) 1000 mg 3x/Week | 0 | 3 |
| Total, all-cause mortality | Phase 1 (Dose Escalation) 1500 mg 3x/Week | 0 | 4 |
| Total, all-cause mortality | Phase 1 (Dose Escalation) 2000 mg 3x/Week | 0 | 6 |
| Total, all-cause mortality | Phase 1 (Dose Escalation) 500 mg 5x/Week | 0 | 3 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers0
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/NCT02030067
GET https://conductscience.org/api/trials/v1/NCT02030067/results?page=2