Metastatic Bladder Cancer, Solid Tumor
Conditions
Keywords
oncology, tumor, metastatic, bladder
Brief summary
The purpose of this study is to determine the maximum tolerated dose of RX-3117 in subjects with advanced or metastatic solid tumors (Phase 1). The purpose of the Phase 2 portion is to estimate anti-tumor activity in subjects with advanced malignancies (relapsed or refractory pancreatic or advanced bladder cancer).
Detailed description
This is a dose-finding, open-label, single agent study of RX-3117. Once the maximum tolerated dose is identified additional subjects will be treated in a dose expansion followed by a 2-stage Phase 2 study. Subjects will be treated for up to 8 cycles of therapy. A cycle will be 4 weeks. RX-3117 dosing will be 3 times each week for 3 weeks follow by 1 week off treatment. All subjects will be followed for at least 30 days after the last dose of RX-3117.
Interventions
DRUGRX-3117
Sponsors
Processa Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females who are 18 years or older * Able to swallow capsules * Histological or cytological evidence of confirmed metastatic pancreatic or advanced bladder cancer * Able to discontinue all anticancer therapies 2 weeks prior to study start * Measurable or evaluable disease using Response Evaluation Criteria in Solid Tumors * Life expectancy of at least 3 months * ECOG performance status of 0 or 1 * Provide written informed consent
Exclusion criteria
* Primary brain tumors or clinical evidence of active brain metastasis * Systemic corticosteroid use within 7 days before planned start of study therapy * Active infection requiring parenteral or oral antibiotics within 2 weeks before planned start of study therapy * Uncontrolled diabetes as assessed by the investigator * Prior or current history of hepatitis B, hepatitis C or human immunodeficiency virus * History of bone marrow of solid organ transplantation * History of congestive heart failure, arrhythmias, acute coronary syndrome or torsades de pointes * Any other medical, psychiatric, or social condition, which in the opinion of the investigator, would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results * Known hypersensitivity to gemcitabine, azacytidine or cytosine arabinoside * Pregnant, planning a pregnancy or breast feeding during the study * Concurrent participation in another therapeutic clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (Phase 2) | 4 months | Progression Free Survival in Phase 2 of the study for pancreatic and bladder cancer subjects. |
| 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 |
| 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. |
| 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. |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
3 patients enrolled in the Phase 2 portion of the study discontinued prior to dosing. Therefore 124 patients started the study rather than 127 patients as listed in the protocol section.
Participants by arm
| Arm | Count |
|---|---|
| RX-3117 30 mg 3 Times/Week Patient received 30 mg RX-3117 3 times/week | 1 |
| RX-3117 60 mg 3 Times/Week Patient received 60 mg RX-3117 3 times/week | 1 |
| RX-3117 100 mg 3 Times/Week Patients received 100 mg RX-3117 3 times/week | 3 |
| RX-3117 150 mg 3 Times/Week Patients received 150 mg RX-3117 3 times/week | 3 |
| RX-3117 200 mg 3 Times/Week Patients received 200 mg RX-3117 3 times/week | 3 |
| RX-3117 500 mg 3 Times/Week Patients received 500 mg RX-3117 3 times/week | 3 |
| RX-3117 1000 mg 3 Times/Week Patients received 1000 mg RX-3117 3 times/week | 3 |
| RX-3117 1500 mg 3 Times/Week Patients received 1500 mg RX-3117 3 times/week | 4 |
| RX-3117 2000 mg 3 Times/Week Patients received 2000 mg RX-3117 3 times/week | 6 |
| RX-3117 500 mg 5 Times/Week Patients received 500 mg RX-3117 5 times/week | 3 |
| RX-3117 700 mg 5 Times/Week Patients received 700 mg RX-3117 5 times/week | 11 |
| RX-3117 500 mg 7 Times/Week Patients received RX-3117 500 mg 7 Times/Week | 3 |
| RX-3117 700 mg 5 Times/Week (Phase 2) Patients received 700 mg RX-3117 5 times/week | 80 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 8 |
| Overall Study | Disease Progression | 1 | 1 | 2 | 2 | 3 | 2 | 3 | 3 | 4 | 3 | 7 | 2 | 59 |
| Overall Study | other reasons | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 4 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 3 | 0 | 6 |
Baseline characteristics
| Characteristic | RX-3117 30 mg 3 Times/Week | RX-3117 60 mg 3 Times/Week | RX-3117 100 mg 3 Times/Week | RX-3117 150 mg 3 Times/Week | RX-3117 200 mg 3 Times/Week | RX-3117 500 mg 3 Times/Week | RX-3117 1000 mg 3 Times/Week | RX-3117 1500 mg 3 Times/Week | RX-3117 2000 mg 3 Times/Week | RX-3117 500 mg 5 Times/Week | RX-3117 700 mg 5 Times/Week | RX-3117 500 mg 7 Times/Week | RX-3117 700 mg 5 Times/Week (Phase 2) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 69.0 years STANDARD_DEVIATION 0 | 66.0 years STANDARD_DEVIATION 0 | 65.3 years STANDARD_DEVIATION 5.86 | 67.0 years STANDARD_DEVIATION 4.58 | 68.0 years STANDARD_DEVIATION 6.24 | 53.7 years STANDARD_DEVIATION 7.57 | 54.3 years STANDARD_DEVIATION 4.16 | 63.3 years STANDARD_DEVIATION 16.5 | 61.0 years STANDARD_DEVIATION 13.3 | 62.0 years STANDARD_DEVIATION 13.08 | 58.0 years STANDARD_DEVIATION 10.87 | 67.0 years STANDARD_DEVIATION 6.56 | 67.6 years STANDARD_DEVIATION 9.11 | 65.37 years STANDARD_DEVIATION 9.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 1 Participants | 5 Participants | 1 Participants | 14 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 4 Participants | 3 Participants | 2 Participants | 6 Participants | 2 Participants | 63 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 1 Participants | 1 Participants | 3 Participants | 5 Participants | 3 Participants | 9 Participants | 2 Participants | 64 Participants | 99 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 4 Participants | 2 Participants | 8 Participants | 3 Participants | 34 Participants | 63 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 0 Participants | 46 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 4 | 0 / 6 | 0 / 3 | 1 / 11 | 0 / 3 | 8 / 80 |
| other Total, other adverse events | 1 / 1 | 1 / 1 | 3 / 3 | 3 / 3 | 3 / 3 | 0 / 3 | 3 / 3 | 4 / 4 | 6 / 6 | 3 / 3 | 11 / 11 | 3 / 3 | 78 / 80 |
| serious Total, serious adverse events | 0 / 1 | 1 / 1 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 1 / 3 | 0 / 4 | 2 / 6 | 2 / 3 | 5 / 11 | 1 / 3 | 29 / 80 |
Outcome results
Primary
Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1
Number of subjects that experience any treatment-related adverse event.
Time frame: through study completion, up to 224 days (8 cycles of treatment)
Population: Population includes subjects participating in the dose escalation phase of the study (Phase 1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RX-3117 30 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | 0 Participants |
| RX-3117 60 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | 1 Participants |
| RX-3117 100 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | 2 Participants |
| RX-3117 150 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | 3 Participants |
| RX-3117 200 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | 3 Participants |
| RX-3117 500 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | 0 Participants |
| RX-3117 1000 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | 2 Participants |
| RX 3117 1500 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | 3 Participants |
| RX-3117 2000 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | 6 Participants |
| RX-3117 500 mg, 5 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | 3 Participants |
| RX-3117 700 mg, 5 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | 9 Participants |
| RX-3117 500 mg, 7 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1 | 3 Participants |
Primary
Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1
Number of subjects participating in Phase 1 that experience any SAEs
Time frame: through study completion, up to 224 days (8 cycles of treatment)
Population: Population includes those subjects participating in the dose escalation phase of the study (Phase 1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RX-3117 30 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | 0 Participants |
| RX-3117 60 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | 1 Participants |
| RX-3117 100 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | 0 Participants |
| RX-3117 150 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | 0 Participants |
| RX-3117 200 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | 0 Participants |
| RX-3117 500 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | 0 Participants |
| RX-3117 1000 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | 1 Participants |
| RX 3117 1500 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | 0 Participants |
| RX-3117 2000 mg, 3 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | 2 Participants |
| RX-3117 500 mg, 5 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | 2 Participants |
| RX-3117 700 mg, 5 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | 5 Participants |
| RX-3117 500 mg, 7 Times/Week | Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1 | 1 Participants |
Primary
Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1
Number of subjects participating in Phase 1 that experienced a DLT during the first cycle of treatment (28 days)
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RX-3117 30 mg, 3 Times/Week | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 0 Participants |
| RX-3117 60 mg, 3 Times/Week | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 0 Participants |
| RX-3117 100 mg, 3 Times/Week | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 0 Participants |
| RX-3117 150 mg, 3 Times/Week | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 0 Participants |
| RX-3117 200 mg, 3 Times/Week | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 0 Participants |
| RX-3117 500 mg, 3 Times/Week | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 0 Participants |
| RX-3117 1000 mg, 3 Times/Week | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 0 Participants |
| RX 3117 1500 mg, 3 Times/Week | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 0 Participants |
| RX-3117 2000 mg, 3 Times/Week | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 1 Participants |
| RX-3117 500 mg, 5 Times/Week | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 0 Participants |
| RX-3117 700 mg, 5 Times/Week | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 0 Participants |
| RX-3117 500 mg, 7 Times/Week | Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1 | 2 Participants |
Primary
Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1
Number of subjects participating in Phase 1 of study that discontinued study treatment due to a treatment emergent adverse event.
Time frame: through study completion, up to 224 days (8 cycles of treatment)
Population: Population includes subjects in the dose escalation phase of the study (Phase 1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RX-3117 30 mg, 3 Times/Week | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | 0 Participants |
| RX-3117 60 mg, 3 Times/Week | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | 0 Participants |
| RX-3117 100 mg, 3 Times/Week | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | 0 Participants |
| RX-3117 150 mg, 3 Times/Week | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | 0 Participants |
| RX-3117 200 mg, 3 Times/Week | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | 0 Participants |
| RX-3117 500 mg, 3 Times/Week | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | 0 Participants |
| RX-3117 1000 mg, 3 Times/Week | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | 0 Participants |
| RX 3117 1500 mg, 3 Times/Week | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | 0 Participants |
| RX-3117 2000 mg, 3 Times/Week | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | 0 Participants |
| RX-3117 500 mg, 5 Times/Week | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | 1 Participants |
| RX-3117 700 mg, 5 Times/Week | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | 0 Participants |
| RX-3117 500 mg, 7 Times/Week | Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1 | 1 Participants |
Primary
Progression Free Survival (Phase 2)
Progression Free Survival in Phase 2 of the study for pancreatic and bladder cancer subjects.
Time frame: 4 months
Population: Patients participating in Phase 2 of the study, which included 41 pancreatic cancer and 31 bladder cancer patients
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| RX-3117 30 mg, 3 Times/Week | Progression Free Survival (Phase 2) | Pancreatic cancer patients | 4.7 weeks |
| RX-3117 30 mg, 3 Times/Week | Progression Free Survival (Phase 2) | Bladder cancer patients | 7.7 weeks |
Secondary
Area Under the Plasma Concentration Time Curve (AUC) (Phase 1)
Time frame: 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
Population: No pharmacokinetic analysis was conducted
Secondary
Best Overall Response Rate (Phase 2)
Best Overall Response Rate (includes Complete Response, Partial Response, and Stable Disease)
Time frame: Baseline and at 4, 8, 12, 16 and 32 weeks
Population: Evaluable for Tumor Response Analysis Set (includes Bladder and Pancreatic patients in Phase 2)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RX-3117 30 mg, 3 Times/Week | Best Overall Response Rate (Phase 2) | pancreatic subjects | 26.8 percentage |
| RX-3117 30 mg, 3 Times/Week | Best Overall Response Rate (Phase 2) | bladder subjects | 45.2 percentage |
Other Pre-specified
Biomarker Concentrations in Blood (Phase 1 and Phase 2)
Analysis of biomarker data not conducted. Biomarker samples were not analyzed due to previous sponsor terminating clinical program.
Time frame: Baseline and 4, 8, 12, 16 and 32 weeks
Population: Analysis of biomarker data not conducted. Biomarker samples were not analyzed due to previous sponsor terminating clinical program.