A Phase 2 interventional study of Onvansertib and Nanoliposomal irinotecan in Pancreatic Ductal Adenocarcinoma, sponsored by Cardiff Oncology. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Cardiff Oncology · Phase 2, Interventional, and Treatment
Sponsor decision based on meeting essential enrollment and obtaining substantial data to support future pancreatic ductal adenocarcinoma (PDAC) trials in a first-line setting.
The main objective of this trial is to assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of participants with histologically confirmed metastatic PDAC.
Cardiff Oncology is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The first 3 participants will be administered onvansertib orally once a day at a dosing schedule of 12 mg/m\^2 on Day 1 to Day 10 for two cycles, where each cycle is 2 weeks. Depending on the number of dose limiting toxicities (DLTs) experienced in the first 3 participants, additional participants may receive different dosing schedules, determining the dosing schedule to be used in the treatment period. Onvansertib will be administered in combination with 70 mg/m\^2 nanoliposomal irinotecan (nal-IRI), 400 mg/m\^2 leucovorin and 2400 mg/m\^2 fluorouracil (5-FU).
Drug: Onvansertib · Drug: Nanoliposomal irinotecan · Drug: Leucovorin · Drug: Fluorouracil
Participants will be administered onvansertib at the dosing schedule selected based on the results of the safety lead-in, in cycles of 2 weeks. Onvansertib will be administered in combination with 70 mg/m\^2 nanoliposomal irinotecan (nal-IRI), 400 mg/m\^2 leucovorin and 2400 mg/m\^2 fluorouracil (5-FU).
Drug: Onvansertib · Drug: Nanoliposomal irinotecan · Drug: Leucovorin · Drug: Fluorouracil
Oral capsule
Also known as: PCM-075
Intravenous infusion
Also known as: Onivyde, Nal-IRI
Intravenous infusion
Intravenous infusion
Also known as: 5-FU
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR was defined as the percentage of participants who achieved a best overall response of confirmed complete reponse (CR) or partial response (PR) determined by the Investigator per RECIST v1.1. According to RECIST 1.1, a CR is the disappearance of all target lesions, with non-target lesions non-existent and no new lesions and a PR is a decrease of at least 30% in the sum of the diameters of target lesions, as long as there are no new lesions and non-target lesions have not worsened. Two-sided 95% confidence interval (CI) was calculated using the exact binomial Clopper-Pearson method.
Time frame: Up to approximately 91 weeks
Overall Survival (OS)
OS was calculated as: OS = (date of death - date of first dose of study treatments + 1)/ 30.4375. 95% CI was estimated using the Kaplan-Meier method.
Time frame: Up to approximately 21 months
Duration of Response (DOR)
DOR was calculated as: DOR = (date of recurrence or progression of disease or all-cause death - date of first confirmed CR or PR + 1)/30.4375. Only participants who had a confirmed CR or PR were included in the analysis, and the percentage was based on the number of participants who had such a response. 95% CI was estimated using the Kaplan-Meier method.
Time frame: Up to approximately 91 weeks
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as AEs that first occurred or worsened in severity on or after the first administration of trial treatments and up to 30 days after the last administration of trial treatments.
Time frame: Up to approximately 91 weeks
Disease Control Rate (DCR)
DCR was defined as the percentage of participants who achieved a best overall response of confirmed CR or PR, or stable disease (SD) determined by the Investigator per RECIST v1.1. Two-sided 95% CI was calculated using the exact binomial Clopper-Pearson method.
Time frame: Up to approximately 91 weeks
A total of 41 participants were enrolled from May 2021 to December 2024 in the United States.
| Milestone | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU |
|---|---|---|---|
| Started | 6 | 2 | 33 |
| Completed | 6 | 2 | 32 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Death | 0 | 0 | 1 |
| Milestone | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU |
|---|---|---|---|
| Started | 6 | 2 | 32 |
| Completed | 0 | 0 | 0 |
| Not completed | 6 | 2 | 32 |
| Withdrew: Death | 6 | 2 | 23 |
| Withdrew: Withdrawal by subject | 0 | 0 | 3 |
| Withdrew: Clinical disease progression | 0 | 0 | 3 |
| Withdrew: Sponsor decision | 0 | 0 | 1 |
| Withdrew: Trial terminated by sponsor | 0 | 0 | 1 |
| Withdrew: Participant transitioned to hospice care | 0 | 0 | 1 |
ORR was defined as the percentage of participants who achieved a best overall response of confirmed complete reponse (CR) or partial response (PR) determined by the Investigator per RECIST v1.1. According to RECIST 1.1, a CR is the disappearance of all target lesions, with non-target lesions non-existent and no new lesions and a PR is a decrease of at least 30% in the sum of the diameters of target lesions, as long as there are no new lesions and non-target lesions have not worsened. Two-sided 95% confidence interval (CI) was calculated using the exact binomial Clopper-Pearson method.
| percentage of participants | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU |
|---|---|---|---|
| Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 (NA to 60.2) | 0 (NA to 84.2) | 10.7 (2.3 to 28.2) |
OS was calculated as: OS = (date of death - date of first dose of study treatments + 1)/ 30.4375. 95% CI was estimated using the Kaplan-Meier method.
| months | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU |
|---|---|---|---|
| Overall Survival (OS) | 3 (1.7 to NA) | 20 (19.2 to NA) | 7 (4.3 to 10.8) |
DOR was calculated as: DOR = (date of recurrence or progression of disease or all-cause death - date of first confirmed CR or PR + 1)/30.4375. Only participants who had a confirmed CR or PR were included in the analysis, and the percentage was based on the number of participants who had such a response. 95% CI was estimated using the Kaplan-Meier method.
| months | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU |
|---|---|---|---|
| Duration of Response (DOR) | — | — | 5 (4.9 to NA) |
TEAEs were defined as AEs that first occurred or worsened in severity on or after the first administration of trial treatments and up to 30 days after the last administration of trial treatments.
| Participants | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU |
|---|---|---|---|
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 6 | 2 | 33 |
DCR was defined as the percentage of participants who achieved a best overall response of confirmed CR or PR, or stable disease (SD) determined by the Investigator per RECIST v1.1. Two-sided 95% CI was calculated using the exact binomial Clopper-Pearson method.
| percentage of participants | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU |
|---|---|---|---|
| Disease Control Rate (DCR) | 25.0 (0.6 to 80.6) | 100 (15.8 to 100) | 53.6 (33.9 to 72.5) |
Collected over Up to approximately 91 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | 6/6 (100%) | 3/6 (50%) | 6/6 (100%) |
| Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | 2/2 (100%) | 2/2 (100%) | 2/2 (100%) |
| Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | 24/33 (72.7%) | 23/33 (69.7%) | 33/33 (100%) |
| Event | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU |
|---|---|---|---|
| Abdominal painGastrointestinal disorders | 1/6 | 1/2 | 0/33 |
| Decreased appetiteMetabolism and nutrition disorders | 0/6 | 1/2 | 0/33 |
| DiarrhoeaGastrointestinal disorders | 1/6 | 0/2 | 3/33 |
| NauseaGastrointestinal disorders | 1/6 | 0/2 | 1/33 |
| VomitingGastrointestinal disorders | 1/6 | 0/2 | 1/33 |
| Small intestinal obstructionGastrointestinal disorders | 1/6 | 0/2 | 0/33 |
| PneumoniaInfections and infestations | 1/6 | 0/2 | 1/33 |
| LeukopeniaBlood and lymphatic system disorders | 1/6 | 0/2 | 1/33 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/6 | 0/2 | 0/33 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/6 | 0/2 | 1/33 |
| Event | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU |
|---|---|---|---|
| VomitingGastrointestinal disorders | 2/6 | 2/2 | 13/33 |
| Abdominal painGastrointestinal disorders | 3/6 | 2/2 | 8/33 |
| StomatitisGastrointestinal disorders | 0/6 | 2/2 | 11/33 |
| HypokalaemiaMetabolism and nutrition disorders | 3/6 | 2/2 | 14/33 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 0/6 | 2/2 | 0/33 |
| NauseaGastrointestinal disorders | 5/6 | 1/2 | 25/33 |
| FatigueGeneral disorders | 5/6 | 1/2 | 27/33 |
| DiarrhoeaGastrointestinal disorders | 2/6 | 1/2 | 22/33 |
| AnaemiaBlood and lymphatic system disorders | 2/6 | 1/2 | 17/33 |
| Abdominal distensionGastrointestinal disorders | 1/6 | 1/2 | 3/33 |
Safety Analysis Set: all patients who had received at least one dose (even partially) of any trial drug, ie, onvansertib, nal-IRI, leucovorin, or 5-FU.
| Age, Categorical(Participants) | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 10 | 12 |
| >=65 years | 5 | 1 | 23 | 29 |
| Sex: Female, Male(Participants) | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Total |
|---|---|---|---|---|
| Female | 0 | 1 | 13 | 14 |
| Male | 6 | 1 | 20 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 6 | 2 | 32 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Safety Lead-in: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Safety Lead-in to Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Treatment Period: Onvansertib + Nal-IRI + Leucovorin + 5-FU | Total |
|---|---|---|---|---|
| Asian | 0 | 0 | 3 | 3 |
| Black or African American | 0 | 1 | 3 | 4 |
| White/Caucasian | 6 | 1 | 26 | 33 |
| Other | 0 | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Sponsor decision based on meeting essential enrollment and obtaining substantial data to support future pancreatic ductal adenocarcinoma (PDAC) trials in a first-line setting.
Sponsor decision based on meeting essential enrollment and obtaining substantial data to support future pancreatic ductal adenocarcinoma (PDAC) trials in a first-line setting.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Onvansertib · Irinotecan sucrosofate · Leucovorin · Fluorouracil
Cardiff Oncology