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Pancreatic Ductal AdenocarcinomaPhase 2NCT04752696

Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma

A Phase 2 study testing Onvansertib, Nanoliposomal irinotecan and Leucovorin in people with Pancreatic Ductal Adenocarcinoma, run by Cardiff Oncology at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
Onvansertib, Nanoliposomal irinotecan and Leucovorin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
6 sitesUnited States
Study dates
25 May 2021to 24 Dec 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically or cytologically confirmed metastatic PDAC
  • Has received 1 prior gemcitabine-based chemotherapy as first line therapy for metastatic disease. Progression after completion of neoadjuvant or adjuvant therapy of < 6 months in duration is considered 1 line of therapy for metastatic disease
  • Has measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Must be willing and able to undergo a tissue biopsy at screening; participants who, in the opinion of the investigator, do not have tissue that is accessible for biopsy are excepted from this criterion
  • Women of childbearing potential: (defined as not post-menopausal for 12 months or no previous surgical sterilization) and fertile men must agree to use adequate contraception for the duration of study participation and for 4 months after the last dose of nal-IRI. Male subjects must agree to refrain from sperm donation during the study and for 4 months after the last dose of nal-IRI
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  • Ability to understand and the willingness to sign a written informed consent document. Signed informed consent form must be obtained prior to initiation of study evaluations and/or activities
  • International Normalized Ratio (INR) < 1.5 unless on warfarin
  • Participants with prior malignancy and who were treated with no evidence of active disease more than 2 years from initial diagnosis are eligible
  • Age ≥ 18 years
  • Participants must have adequate organ and bone marrow function

Who cannot join

  • Prior treatment with irinotecan, nal-IRI, or investigational PLK1 inhibitor
  • Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and myocardial infarction within 3 months of initiation of therapy
  • History of interstitial pneumonitis or interstitial lung disease
  • Participants with microsatellite instability-high (MSI-H) tumors with no prior immune checkpoint inhibitor exposure
  • Pregnancy or lactation
  • Participant has active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
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  • QT interval with Fridericia's correction (QTcF) > 470 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate electrocardiograms (ECGs). In the case of potentially correctible causes of QT prolongation, (eg, medications, hypokalemia), the triplicate ECG may be repeated once during Screening and that result may be used to determine eligibility
  • Planned concomitant use of medications known to prolong the QT/QTc interval
  • Participant has undergone major surgical resection within 4 weeks prior to enrollment
  • Participant received radiotherapy, surgery, chemotherapy, or an investigational therapy within 2 weeks prior to study entry
  • Participant has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the participant to receive an experimental research drugs
  • Serious psychiatric or medical conditions that could interfere with treatment
  • Major bleeding in the last 4 weeks
  • More than 1 prior chemotherapy regimen administered in the metastatic setting
  • Unable or unwilling to swallow oral medication
  • Use of strong CYP3A4 or UGT1A1 inhibitors or strong CYP3A4 inducers. Participants currently receiving these agents who are able to switch to alternate therapy are not excluded. Inhibitors should be stopped at least one week prior to the first dose of protocol therapy and inducers should be stopped at least two weeks prior to initiation of protocol therapy.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • University of Kansas Medical Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: A Phase 2 Study of Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Patients With Metastatic Pancreatic Ductal Adenocarcinoma

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.

Being tested
Onvansertib, Nanoliposomal irinotecan, Leucovorin, Fluorouracil
Keywords
Pancreatic Ductal Adenocarcinoma, Onvansertib, Nanoliposomal irinotecan, Leucovorin, Fluorouracil, PLK1, PLK Inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OnvansertibDrug

    Also called PCM-075

    Oral capsule

  • Nanoliposomal irinotecanDrug

    Also called Onivyde, Nal-IRI

    Intravenous infusion

  • LeucovorinDrug

    Intravenous infusion

  • FluorouracilDrug

    Also called 5-FU

    Intravenous infusion

Study groups in NCT04752696
Study groupRoleWhat they receive
Safety Lead-in: Onvansertib + nal-IRI + leucovorin + 5-FUExperimentalThe 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).
Receives: Drug: Onvansertib; Drug: Nanoliposomal irinotecan; Drug: Leucovorin; Drug: Fluorouracil
Treatment Period: Onvansertib + nal-IRI + leucovorin + 5-FUExperimentalParticipants 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).
Receives: Drug: Onvansertib; Drug: Nanoliposomal irinotecan; Drug: Leucovorin; Drug: Fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 91 weeks

Secondary outcomes (4)

  1. 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.

    Measured: Up to approximately 21 months

  2. 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.

    Measured: Up to approximately 91 weeks

  3. 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.

    Measured: Up to approximately 91 weeks

  4. 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.

    Measured: Up to approximately 91 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study start25 May 2021
  3. Primary completion24 Dec 2024
  4. Study completion24 Dec 2024

Why it stopped: Sponsor decision based on meeting essential enrollment and obtaining substantial data to support future pancreatic ductal adenocarcinoma (PDAC) trials in a first-line setting.

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04752696
Sponsor's protocol ID
CRDF-001
Status last verified
Jun 2026
First submitted
9 Feb 2021
Last updated
4 Nov 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Onvansertib, Nanoliposomal irinotecan and Leucovorin in people with Pancreatic Ductal Adenocarcinoma, run by Cardiff Oncology 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 11 inclusion and 16 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: stopped early, as of the sponsor's last update on 4 Nov 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: Up to approximately 91 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04752696.

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 4 Nov 2026.

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