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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04861987
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : February 22, 2022
Information provided by (Responsible Party):
Processa Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Refractory Cancer Tumor Gastric Drug: PCS6422 and capecitabine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of Fixed-dose PCS6422 With Escalating Doses of Capecitabine Administered Orally to Patients With Advanced, Refractory Gastrointestinal Tract Tumors
Actual Study Start Date : June 18, 2021
Estimated Primary Completion Date : September 20, 2022
Estimated Study Completion Date : March 10, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PCS6422 + Capecitabine
Fixed dose of PCS6422 combined with various doses of Capecitabine administered in 14 day cycles
Drug: PCS6422 and capecitabine
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.

Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities (DLT) and incidence of adverse events as assessed by CTCAE v5.0 [ Time Frame: ~6 months ]
    Frequency, duration, and severity of DLTs and adverse events (AEs)

  2. Maximum Plasma Concentration (Cmax) of capecitabine [ Time Frame: ~14 days ]
    To evaluate the Maximum Plasma Concentration (Cmax) of capecitabine

Secondary Outcome Measures :
  1. QTc effect of PCS6422 [ Time Frame: ~6 months ]
    To evaluate the effect of PCS6422 on QTc

  2. Maximum Plasma Concentration (Cmax) of PCS6422 [ Time Frame: ~14 days ]
    To evaluate the Maximum Plasma Concentration (Cmax) of PCS6422

  3. Number of participants with Adverse Events of Special Interest (AESI) [ Time Frame: ~6 months ]
    Frequency, duration and severity of AESIs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Has measurable disease in accordance with Respond Evaluation Criteria in Solid Tumors (RECIST) guidelines (Version 1.1).
  3. Is aged ≥18 years
  4. Has not received treatment with intravenous (IV) 5 FU or oral 5 FU analogs in the 4 weeks preceding enrollment
  5. Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at study entry
  6. Has adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment:

    1. peripheral ANC of ≥1.5 × 109/L
    2. platelet count of ≥75 × 109/L without growth factor/transfusion
    3. hemoglobin ≥8.5 g/dL without growth factor/transfusion
    4. estimated glomerular filtration rate >50 mL/min
    5. 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
    6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN, with liver metastasis <5 × ULN
    7. international normalized ratio (INR) <1.5
  7. Has a life expectancy of at least 12 weeks
  8. 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
  9. Females of childbearing potential must have a negative serum β human chorionic gonadotropin pregnancy test result
  10. Willingly provides written, informed consent.
  11. Has resolution or stabilization of acute toxicity from prior therapy to Grade <2 - except Grade 2 neuropathy
  12. If patient has human immune deficiency virus (HIV) infection, it is controlled with undetectable viral load with antiretroviral treatment.
  13. If patient has hepatitis C infection and received antiviral treatment, has a negative viral load at Screening
  14. If patient has chronic hepatitis B infection and is receiving antiviral treatment, has a negative viral load at Screening.
  15. Is willing and able to comply with all protocol required visits and assessments

Exclusion Criteria:

  1. Is unable to take oral medication or malabsorption syndromes potentially interfering with medication absorption (e.g., short bowel syndrome or chronic, partial bowel obstruction)
  2. Has history or presence of clinically significant abnormal 12 lead ECG results, in the investigator's opinion
  3. Has current brain metastasis
  4. Has prolonged QTc (with Fridericia's correction) of >480 msec in men and women performed at Screening
  5. 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
  6. Has congenital long QT syndrome or a family history of long QT syndrome
  7. 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
  8. Has an electrolyte disturbance, such as uncorrected hypokalemia/hyperkalemia, hypomagnesemia, or hypocalcemia. Patients can be enrolled following successful correction of an electrolyte disturbance.
  9. Is currently using any drugs included in the prohibited medications list in the protocol (including those that can prolong QTc) that cannot be discontinued
  10. Has known hypersensitivity to any of the components of study treatments
  11. 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
  12. Is a pregnant or lactating female
  13. Had major surgery, open biopsy, or significant traumatic injury within 4 weeks prior to the first dose of study treatment
  14. Is receiving or has received any investigational treatment within 4 weeks prior to study entry, or participating in another clinical study
  15. Has known DPD deficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04861987

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Contact: Mary Nyberg 443-776-3133 mnyberg@processapharmaceuticals.com

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United States, Nebraska
Processa Clinical Site Recruiting
Omaha, Nebraska, United States, 68198
Contact: Debbie Vidlak    402-559-7507    dvidlak@unmc.edu   
Principal Investigator: Jean Grem, MD         
United States, New Jersey
Processa Clinical Site Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Ahsan Khan    732-235-3458    ark140@cinj.rutgers.edu   
Principal Investigator: Patrick Boland, MD         
United States, New Mexico
Processa Clinical Site Recruiting
Santa Fe, New Mexico, United States, 87505
Contact: Olivia Sloan    505-913-8933    olivia.sloan@nmcancercare.com   
Principal Investigator: Scott Herbert, MD         
United States, New York
Processa Clinical Site Recruiting
New York, New York, United States, 10467
Contact: Mohammed Ghalib    718-405-8527    mhghalib@montefiore.org   
Principal Investigator: Ana Acuna-Villaorduna, MD         
United States, Virginia
Processa Clinical Site Recruiting
Fairfax, Virginia, United States, 22031
Contact: Sharon Goldberg       sharon.goldberg@usoncology.com   
Principal Investigator: Alexander Spira, MD         
Sponsors and Collaborators
Processa Pharmaceuticals
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Study Director: Sian Bigora, Pharm. D Processa Pharmaceuticals
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Responsible Party: Processa Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04861987    
Other Study ID Numbers: PCS6422-GI-01
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: February 22, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Processa Pharmaceuticals:
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents