A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors

NCT04861987 | Completed Phase 1 FDA Drug

• 1 other identifier: PCS6422-GI-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Advanced Cancer; Refractory Cancer; Tumor Gastric

Keywords

Capecitabine; Eniluracil

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• QTc effect of PCS6422

  ~6 months

• Maximum Plasma Concentration (Cmax) of PCS6422

  ~14 days

• Number of participants with Adverse Events of Special Interest (AESI)

  ~6 months

Study Arms (1)

PCS6422 + Capecitabine

EXPERIMENTAL

Fixed dose of PCS6422 combined with various doses of Capecitabine administered in 14 day cycles

Drug: PCS6422 and capecitabine

Interventions

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.

PCS6422 + Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• peripheral ANC of ≥1.5 × 109/L
• platelet count of ≥75 × 109/L without growth factor/transfusion
• hemoglobin ≥8.5 g/dL without growth factor/transfusion
• estimated glomerular filtration rate \>50 mL/min
• total bilirubin \<2 × upper limit of normal (ULN); \<5 × ULN if patient has liver metastases, biliary tract cancer; or ≤3 × ULN if the patient has Gilbert's disease
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<2.5 × ULN, with liver metastasis \<5 × ULN
• international normalized ratio (INR) \<1.5
• 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

You may not qualify if:

• Is unable to take oral medication or malabsorption syndromes potentially interfering with medication absorption (e.g., short bowel syndrome or chronic, partial bowel obstruction)
• Has history or presence of clinically significant abnormal 12 lead ECG results, in the investigator's opinion
• Has current brain metastasis
• Has prolonged QTc (with Fridericia's correction) of \>480 msec in men and women performed at Screening
• Has a history of prolonged QTc interval, ventricular tachycardia/fibrillation or significant ventricular arrhythmia, or Torsades de Pointes, or a history of ventricular ablation for arrhythmia
• Has congenital long QT syndrome or a family history of long QT syndrome
• Has other clinically significant cardiac disease including, but not limited to, uncontrolled angina, myocardial ischemia or infarction within 6 months, congestive heart failure \>Class II per the New York Heart Association, or history of myocarditis
• Has an electrolyte disturbance, such as uncorrected hypokalemia/hyperkalemia, hypomagnesemia, or hypocalcemia. Patients can be enrolled following successful correction of an electrolyte disturbance.
• Is currently using any drugs included in the prohibited medications list in the protocol (including those that can prolong QTc) that cannot be discontinued
• Has known hypersensitivity to any of the components of study treatments
• Has other primary cancer requiring treatment within the last 3 years, except for cervical intraepithelial neoplasia, ductal carcinoma in situ, or completely excised squamous or basal cell carcinoma
• Is a pregnant or lactating female
• Had major surgery, open biopsy, or significant traumatic injury within 4 weeks prior to the first dose of study treatment
• Is receiving or has received any investigational treatment within 4 weeks prior to study entry, or participating in another clinical study
• Has known DPD deficiency

Sponsors & Collaborators

• Processa Pharmaceuticals: lead

Study Sites (6)

Processa Clinical Site

Omaha, Nebraska, 68198, United States

Location

Processa Clinical Site

New Brunswick, New Jersey, 08903, United States

Location

Processa Clinical Site

Santa Fe, New Mexico, 87505, United States

Location

Processa Clinical Site

New York, New York, 10467, United States

Location

Processa Clinical Site

Cleveland, Ohio, 44106, United States

Location

Processa Clinical Site

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Neoplasms; Stomach Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Sian Bigora, Pharm. D

  Processa Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 27, 2021
• Study Start: June 18, 2021
• Primary Completion: June 12, 2024
• Study Completion: September 9, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)