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Pancreatic CancerPhase 1/2PANCONVANCT06736717

Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer

A Phase 1/2 study testing Onvansertib and NALIRIFOX in people with Pancreatic Cancer, run by University of Kansas Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Pancreatic cancer is a deadly disease and will be the second leading cause of cancer related death behind lung cancer by 2030. Over 62,000 people are diagnosed each year in the United States with about 90% succumbing to the disease within 5 years. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Onvansertib and NALIRIFOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
17 Feb 2025to Jan 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Ability of participant to understand this study, and participant willingness to sign a written informed consent. Remote consenting will be allowed on a case-by-case basis, but will not replace in-person visits for labs/physical, etc.
  • Males and females age ≥ 18 years
  • ECOG Performance Status 0 - 1
  • Measurable disease by RECIST 1.1
  • Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
  • Locally advanced unresectable or metastatic disease who are treatment naive
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  • No previous systemic therapy in the metastatic setting
  • Participant must be willing to submit archival tissue if available and sufficient - otherwise fresh biopsy collection will be performed at screening UNLESS it is deemed medically unsafe for the participant. If participant does not have archival tissue and is not able to undergo a fresh biopsy at this time, enrollment will be per the principal investigator's discretion
  • Adequate organ function, defined as follows:
  • Leukocytes (White Blood Cell [WBC]) > 3 K/UL
  • Absolute Neutrophil Count >1.5K/UL
  • Platelets >100K/UL
  • Hemoglobin ≥ 9 g/dL(level must be maintained without transfusions)
  • Calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation
  • Total bilirubin ≤ 1.5 x ULN
  • If known Gilbert's syndrome then discuss with principal investigator. Email documentation of discussion and approval will be saved and documented for source.
  • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
  • Women of child-bearing potential (WOCBP) and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section.

Who cannot join

  • Simultaneously enrolled in any therapeutic clinical trial
  • Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
  • Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
  • Is pregnant or breastfeeding
  • Has a known allergic reaction to any excipient contained in the study drug formulation
  • Active Grade 3 (per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.027) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
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  • Patient has had major surgery within 4 weeks prior to enrollment
  • Untreated or symptomatic brain metastasis
  • Gastrointestinal (GI) disorder(s) that, in the opinion of the Investigator, would significantly impede the absorption of an oral agent (e.g., intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)
  • Unable or unwilling to swallow study drug
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure (CHF) Class II or higher according to the New York Heart Association (NYHA) Functional Classification, unstable angina pectoris, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection
  • Known active infection with HIV, with measurable viral titer, and/or active infection with hepatitis B or C (patients who have had a hepatitis B virus immunization are eligible)
  • Known active infection with SARS-CoV-2 where symptoms are present
  • Clinically significant ascites or pleural effusions
  • Patients with a history of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or prostate, or other solid tumors curatively treated with no evidence of disease for > 2 years
  • Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive study drug per PI discretion.
  • Any condition (e.g., psychological, geographical, etc.) that does not permit compliance with the protocol
  • Treatment with any of the drugs listed in section with title; Prohibited or Restricted Concomitant Medications at the time of study treatment initiation. Planned concomitant use of medications known to prolong the QT/QTc interval according to institutional guidelines. Use of strong CYP3A4 or CYP2C19 inhibitors or strong CYP3A4 inducers. Patients currently receiving these agents who can be switched to alternate therapy are not excluded. Inhibitors should be stopped at least 1 week prior to the first dose of protocol therapy and inducers should be stopped at least 2 weeks prior to initiation of protocol therapy
  • QT interval: Fridericia's correction (QTcF) > 470 milliseconds.
  • A single ECG is sufficient. Triplicate may be done per PI discretion. If triplicate ECG completed, the QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation that are readily corrected (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during Screening and that result may be used to determine eligibility
  • Presence of risk factors for torsade de pointes, including family history of Long QT Syndrome or uncorrected hypokalemia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Kansas Cancer Center, Westwood Campus

    Kansas City, Kansas, 66205

Other trials in United States

About this study

Official title: A Phase 1b/2 Trial of Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer

Pancreatic cancer is a deadly disease and will be the second leading cause of cancer related death behind lung cancer by 2030. Over 62,000 people are diagnosed each year in the United States with about 90% succumbing to the disease within 5 years. In the metastatic setting, NALIRIFOX, FOLFIRINOX and nab-paclitaxel-gemcitabine are standard treatment options in patients with good performance status (Eastern Cooperative Oncology Group [ECOG] 0/1). All three combinations have shown a survival advantage over previously standard gemcitabine-based therapy, with 11.1 months overall survival (OS) for NALIRIFOX/FOLFIRINOX and 8.7 months for nab-paclitaxel-gemcitabine versus 6.7 months for gemcitabine alone. There is an urgent need to improve treatment of patients with current and emerging therapeutic strategies.

KRAS is the most common oncogene mutated in pancreatic adenocarcinoma, and it is mutated in nearly all tumors. Mutant KRAS is essential for PDAC growth, where the constitutive activated RAS proteins contribute to tumorigenesis, treatment resistance, and metastases. Despite research and drug development efforts focused on KRAS, no effective RAS inhibitors have been approved for the treatment of pancreatic cancer with KRAS mutation. The poor prognosis of KRAS-mutated PDAC patients and the absence of KRAS-targeted therapies, highlight the urgency to develop novel therapies aimed at KRAS.

This study will investigate onvansertib (also known as PCM-075 and NMS-1286937) as the first PLK1-specific adenosine triphosphate competitive inhibitor administered by oral route to enter clinical trials with proven antitumor activity in different preclinical models.

Being tested
Onvansertib, NALIRIFOX
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • OnvansertibDrug

    Also called PCM-075, NMS-1286937

    20 or30mg flat dose - depending on results from safety lead-in. Administered concurrently with NALIRIFOX.

    Once daily on D1-5 of each 14-day cycle.

  • NALIRIFOXDrug

    Chemotherapy regimen of nanoliposomal irinotecan, oxaliplatin, fluorouracil [5-FU], and leucovorin.

    Intravenously on Day 1 of each 14-day cycle.

Study groups in NCT06736717
Study groupRoleWhat they receive
TreatmentExperimentalStudy Drug: Onvansertib: Orally daily on D1 - 5 of each 14-day cycle NALIRIFOX Intravenous D1 of each 14-day cycle
Receives: Drug: Onvansertib; Drug: NALIRIFOX

What is being measured

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

  1. Overall Response Rate (ORR)

    Imaging RECIST 1.1

    Measured: Approximately 2 years

Secondary outcomes (5)

  1. Adverse Events

    The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.025

    Measured: 2 years

  2. Anti-tumor activity by Disease Control Rate (DCR)

    Calculated as the percentage of participants that achieve any of the following at 8 weeks: complete response, partial response, or stable disease, as defined by RECIST v1.1.

    Measured: 8 weeks

  3. Anti-tumor activity by Duration of Response (DOR)

    Calculated as the average length of time between response to treatment and disease progression, defined per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    Measured: 2 years

  4. Progression Free Survival (PFS)

    The duration of time from start of treatment until objective tumor progression or death, as determined by medical record imaging

    Measured: 2 years

  5. Overall Survival (OS)

    Duration of time from start of treatment to death, determined by medical record

    Measured: 2 years

Timeline

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

  1. First posted17 Dec 2024
  2. Study start17 Feb 2025
  3. Primary completion16 Jul 2026
  4. Study completionJan 2027 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06736717
Sponsor's protocol ID
STUDY00161071
Acronym
PANCONVA
Status last verified
Sep 2026
First submitted
20 Nov 2024
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

    PubMed 19097774

  • Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.1158/0008-5472.CAN-14-0155.

    PubMed 24840647

  • Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

    PubMed 21561347

  • U.S. Food and Drug Administration. Drug Development and Drug Interactions / Table of Substrates, Inhibitors and Inducers. URL: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers

  • Smith TJ, Bohlke K, Lyman GH, Carson KR, Crawford J, Cross SJ, Goldberg JM, Khatcheressian JL, Leighl NB, Perkins CL, Somlo G, Wade JL, Wozniak AJ, Armitage JO; American Society of Clinical Oncology. Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015 Oct 1;33(28):3199-212. doi: 10.1200/JCO.2015.62.3488. Epub 2015 Jul 13.

    PubMed 26169616

  • Alembic Pharmaceuticals Inc. FLUOROURACIL - fluorouracil injection, solution. Package Insert Revised 10-2023

  • Hospira. OXALIPLATIN injection, for intravenous use. Package Insert Revised 09-2023

  • National Institute of Health/National Cancer Institute - Cancer Therapy Evaluation Program (CTEP). Common Terminology Criteria for Adverse Events (CTCAE). URL: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#ctc_60

  • United States Food and Drug Administration. FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma. 02-13-2024. URL: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-irinotecan-liposome-first-line-treatment-metastatic-pancreatic-adenocarcinoma

  • Cardiff Oncology. Investigator's Brochure - Onvansertib (also known as PCM-075 and NMS-1286937) Edition 13 dated 09-19-2023

  • Weichert W, Kristiansen G, Schmidt M, Gekeler V, Noske A, Niesporek S, Dietel M, Denkert C. Polo-like kinase 1 expression is a prognostic factor in human colon cancer. World J Gastroenterol. 2005 Sep 28;11(36):5644-50. doi: 10.3748/wjg.v11.i36.5644.

    PubMed 16237758

  • Weichert W, Kristiansen G, Winzer KJ, Schmidt M, Gekeler V, Noske A, Muller BM, Niesporek S, Dietel M, Denkert C. Polo-like kinase isoforms in breast cancer: expression patterns and prognostic implications. Virchows Arch. 2005 Apr;446(4):442-50. doi: 10.1007/s00428-005-1212-8. Epub 2005 Mar 23.

    PubMed 15785925

  • Luo J, Emanuele MJ, Li D, Creighton CJ, Schlabach MR, Westbrook TF, Wong KK, Elledge SJ. A genome-wide RNAi screen identifies multiple synthetic lethal interactions with the Ras oncogene. Cell. 2009 May 29;137(5):835-48. doi: 10.1016/j.cell.2009.05.006.

    PubMed 19490893

  • Lenz H-J, Kasi A, Mendelsohn L, et al. A phase 1b/2 trial of the PLK1 inhibitor onvansertib in combination with FOLFIRI-bev in 2L treatment of KRAS-mutated (mKRAS) metastatic colorectal carcinoma (mCRC). JCO. 2022.40.4 suppl.100. URL: https://ascopubs.org/doi/10.1200/JCO.2022.40.4_suppl.100

  • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.

    PubMed 2702835

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Onvansertib and NALIRIFOX in people with Pancreatic Cancer, run by University of Kansas Medical Center at 1 site 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 18 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

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?

This study is still under way. Results are not available in the source record yet.

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) (time frame: Approximately 2 years). 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 NCT06736717, which also lists 25 linked publications.

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 25 Sep 2026.

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