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This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are candidates for fluoropyrimidine monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCS6422 + Capecitabine | Experimental | Fixed dose of PCS6422 combined with various doses of Capecitabine administered in 14 day cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCS6422 and capecitabine | Drug | PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer. Capecitabine is a commonly used oral fluoropyrimidine. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicities (DLT) and incidence of adverse events as assessed by CTCAE v5.0 | Frequency, duration, and severity of DLTs and adverse events (AEs) | ~6 months |
| Maximum Plasma Concentration (Cmax) of capecitabine | To evaluate the Maximum Plasma Concentration (Cmax) of capecitabine | ~14 days |
| Measure | Description | Time Frame |
|---|---|---|
| QTc effect of PCS6422 | To evaluate the effect of PCS6422 on QTc | ~6 months |
| Maximum Plasma Concentration (Cmax) of PCS6422 | To evaluate the Maximum Plasma Concentration (Cmax) of PCS6422 |
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Inclusion Criteria:
Has advanced, metastatic or unresectable GI tract tumors that are refractory or intolerant to existing available therapies and for whom the investigator recommends fluoropyrimidine monotherapy.
Has measurable disease in accordance with Respond Evaluation Criteria in Solid Tumors (RECIST) guidelines (Version 1.1).
Is aged ≥18 years
Has not received treatment with intravenous (IV) 5 FU or oral 5 FU analogs in the 4 weeks preceding enrollment
Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at study entry
Has adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment:
Has a life expectancy of at least 12 weeks
Female patients of childbearing potential and male patients with partners capable of reproduction must agree to use an effective contraceptive method from the time of Screening through 60 days after the last dose of capecitabine
Females of childbearing potential must have a negative serum β human chorionic gonadotropin pregnancy test result
Willingly provides written, informed consent.
Has resolution or stabilization of acute toxicity from prior therapy to Grade <2 - except Grade 2 neuropathy
If patient has human immune deficiency virus (HIV) infection, it is controlled with undetectable viral load with antiretroviral treatment.
If patient has hepatitis C infection and received antiviral treatment, has a negative viral load at Screening
If patient has chronic hepatitis B infection and is receiving antiviral treatment, has a negative viral load at Screening.
Is willing and able to comply with all protocol required visits and assessments
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sian Bigora, Pharm. D | Processa Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Processa Clinical Site | Omaha | Nebraska | 68198 | United States | ||
| Processa Clinical Site |
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| ~14 days |
| Number of participants with Adverse Events of Special Interest (AESI) | Frequency, duration and severity of AESIs | ~6 months |
| New Brunswick |
| New Jersey |
| 08903 |
| United States |
| Processa Clinical Site | Santa Fe | New Mexico | 87505 | United States |
| Processa Clinical Site | New York | New York | 10467 | United States |
| Processa Clinical Site | Cleveland | Ohio | 44106 | United States |
| Processa Clinical Site | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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