Advanced CancerPhase 1NCT04861987
A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors
A Phase 1 study testing PCS6422 and capecitabine in people with Advanced Cancer and Refractory Cancer, run by Processa Pharmaceuticals at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Refractory Cancer, Tumor Gastric
- What is being tested?
- PCS6422 and capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Jun 2021to 9 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 22Show fewer
- 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
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Processa Clinical Site
Cleveland, Ohio, 44106
Processa Clinical Site
Fairfax, Virginia, 22031
Processa Clinical Site
New Brunswick, New Jersey, 08903
Processa Clinical Site
New York, New York, 10467
Processa Clinical Site
Omaha, Nebraska, 68198
Processa Clinical Site
Santa Fe, New Mexico, 87505
About this study
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
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
- Being tested
- PCS6422 and capecitabine
- Keywords
- Capecitabine, Eniluracil
- Medical subject headings
- Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCS6422 and capecitabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| PCS6422 + Capecitabine | Experimental | Fixed dose of PCS6422 combined with various doses of Capecitabine administered in 14 day cycles Receives: Drug: PCS6422 and capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: ~6 months
Maximum Plasma Concentration (Cmax) of capecitabine
To evaluate the Maximum Plasma Concentration (Cmax) of capecitabine
Measured: ~14 days
Secondary outcomes (3)
QTc effect of PCS6422
To evaluate the effect of PCS6422 on QTc
Measured: ~6 months
Maximum Plasma Concentration (Cmax) of PCS6422
To evaluate the Maximum Plasma Concentration (Cmax) of PCS6422
Measured: ~14 days
Number of participants with Adverse Events of Special Interest (AESI)
Frequency, duration and severity of AESIs
Measured: ~6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start18 Jun 2021
- Primary completion12 Jun 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Processa Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sian Bigora, Pharm. D, Study director, Processa Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861987
- Sponsor's protocol ID
- PCS6422-GI-01
- Status last verified
- Sep 2024
- First submitted
- 23 Apr 2021
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04861987
- Acronym / sponsor ID
- PCS6422-GI-01
- Conditions
- Advanced Cancer, Refractory Cancer, Tumor Gastric
- Keywords
- Capecitabine, Eniluracil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Processa PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCS6422 + Capecitabine | Experimental | Drug: PCS6422 and capecitabineFixed dose of PCS6422 combined with various doses of Capecitabine administered in 14 day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCS6422 and capecitabinePCS6422 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. | Drug | PCS6422 + Capecitabine |
Primary outcome
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)
Maximum Plasma Concentration (Cmax) of capecitabine
Time frame: ~14 days
To evaluate the Maximum Plasma Concentration (Cmax) of capecitabine
3 secondary outcomes
QTc effect of PCS6422
Time frame: ~6 months
Maximum Plasma Concentration (Cmax) of PCS6422
Time frame: ~14 days
Number of participants with Adverse Events of Special Interest (AESI)
Time frame: ~6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sian Bigora, Pharm. D study director
Processa Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PCS6422 and capecitabine in people with Advanced Cancer and Refractory Cancer, run by Processa Pharmaceuticals at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities (DLT) and incidence of adverse events as assessed by CTCAE v5.0 (time frame: ~6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.