Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor indicated for the treatment of: • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. FDA label
Also known as Abraxane
RX-3117 · 2 trials · 3 indications
Number of participants who experienced a treatment-related adverse event
Participants with adverse events coded using the MedDRA Dictionary (Version 20.0) to Investigations. Due to the underlying disease, not all abnormal labs are reported.
Number of participants with clinically significant vital sign abnormalities (Phase 1 and 2) including heart rate, respiration rate, and blood pressure
Number of participants with clinically significant ECG abnormalities (Phase 1 and 2)
Participants must have progression Free Survival (PFS) \> 4 months or objective clinical response (complete or partial response).
Number of subjects participating in Phase 1 that experienced a DLT during the first cycle of treatment (28 days)
Number of subjects participating in Phase 1 that experience any SAEs
Number of subjects participating in Phase 1 of study that discontinued study treatment due to a treatment emergent adverse event.
Number of subjects that experience any treatment-related adverse event.
Progression Free Survival in Phase 2 of the study for pancreatic and bladder cancer subjects.
| Arm | Type | Description |
|---|---|---|
| RX-3117 + Abraxane | EXPERIMENTAL | RX-3117: oral, 500 - 700 mg/ day for 5 days on/ 2 days off for 3 weeks. 1 washout week/ cycle. Abraxane: 75 - 125 mg/m\^2, infused once per week for 3 weeks. 1 washout week/ cycle. |
| RX-3117 | EXPERIMENTAL | All subjects will receive RX-3117. |
| Name | Type | Description |
|---|---|---|
| RX-3117 | DRUG | RX-3117 will be administered orally in combination with Abraxane. |
Inclusion Criteria: Disease Related 1. Subject has confirmed histologic or cytologic evidence of metastatic pancreatic cancer and has no prior treatment for metastatic pancreatic cancer. 2. Subject has measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. 3. Subject...
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RX-3117 is an investigational small molecule being studied for the treatment of metastatic pancreatic cancer and solid tumors. It is currently in Phase 1 clinical development for these oncology indications.
RX-3117 is being developed by Processa Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PCSA.
RX-3117 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials for the drug are in early-stage development.
RX-3117 has been studied in two completed Phase 1 clinical trials. One trial, NCT02030067, evaluated the drug as a single agent in patients with advanced solid tumors and metastatic bladder cancer. Another trial, NCT03189914, studied RX-3117 in combination with Abraxane in patients with metastatic pancreatic cancer.
RX-3117 is also known by its chemical name, 4-amino-1-(4-cyano-5-(2,2-dimethyl-4,4-diphenyl-tetrahydrofuran-3-yl)-1H-pyrazol-1-yl)-2-(4-cyclopropyl-1H-1,2,3-triazol-1-yl)ethan-1-one. It is a distinct investigational compound developed by Processa Pharmaceuticals.