Phase 1 Pancreatic Cancer Trial, Recruiting NCT03454035 Sponsor: UNC Lineberger Comprehensive Cancer Center Condition: Pancreatic Cancer
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Phase 1 Pancreatic Cancer Trial, Recruiting

NCT03454035
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older (there is no upper age limit)
  • You have given written permission to take part and for your health information to be used
  • You are generally able to care for yourself and carry out some daily activities, even if you cannot do heavy physical work (confirm with trial site what level of ability is needed)
  • You have a solid tumor cancer that has stopped responding to standard treatments, or there is no standard treatment available — OR, for certain groups, you have metastatic pancreatic cancer or advanced melanoma and have already had at least one treatment
  • For the melanoma group specifically: your tumor has certain genetic changes (such as in the NRAS, KRAS, HRAS, or NF1 genes), and your cancer has continued to grow despite at least one immunotherapy treatment — or you were unable to receive immunotherapy for medical reasons (confirm with trial site)
  • Your cancer can be measured or at least tracked on scans
  • Doctors expect you to live for at least 12 weeks
  • Side effects from your last cancer treatment have mostly gone away (minor hair loss is acceptable; some mild nerve-related symptoms may still be allowed)
  • Your blood counts, kidney function, and liver function are within acceptable ranges based on recent lab tests
  • Your heart is working well enough, based on a heart ultrasound (echocardiogram)
  • If you are a woman who could become pregnant, you have a negative pregnancy test shortly before starting the study
  • You and your partner are willing to use effective birth control during the study and for 120 days after finishing treatment
  • You are willing and able to follow all study procedures
  • If joining the expansion group, you are willing to provide tumor tissue samples before and during treatment, if it is safe to do so

Who may not be able to join:

  • You are pregnant or currently breastfeeding
  • You have had cancer treatment (such as chemotherapy, radiation, or immunotherapy) or been in another experimental study within the past 28 days (or within 5 half-lives of the drug, whichever is shorter) before starting this trial
  • You have a history of, or are at risk for, certain eye conditions involving blood vessels in the retina (confirm with trial site)
  • You have had major surgery within the past 28 days before starting the trial
  • You are unwilling to avoid grapefruit, grapefruit juice, certain citrus fruits, and related products throughout the study
  • You have taken herbal supplements or remedies (such as St. John's Wort or ginkgo biloba) within 7 days before starting the trial
  • You are taking certain medications that strongly affect how the body processes drugs and you are unable or unwilling to stop them (confirm with trial site for the specific list)
  • You are taking certain other medications that interact with the study drug and are unable or unwilling to stop them (confirm with trial site)
  • You have cancer that has spread to the brain or spine — unless you have RAS-mutated or NF1-mutant melanoma and meet specific conditions: no disease in the lining of the brain, your brain disease is controlled, and you are on a stable or low dose of steroids
  • You have a serious medical condition or abnormal lab result that the doctor believes would make it unsafe for you to participate
  • You have a mental health or personal situation that would make it difficult to follow the study requirements
  • You have another active cancer that is growing and needs treatment (some exceptions apply, such as certain early-stage or fully treated cancers — confirm with trial site)
  • You have a condition that seriously affects your ability to absorb food or medication in your digestive system (such as inflammatory bowel disease or uncontrolled vomiting/diarrhea)
  • You are unable to swallow tablets or capsules
  • You have an autoimmune disease that requires ongoing steroid treatment

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Stergios Moschos, MD, University of North Carolina, Chapel Hill

Phone: 919-966-4432

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
UNC Lineberger Comprehensive Cancer Center
Registry
ClinicalTrials.gov
Start date
30 January 2018
Est. completion
15 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximum Tolerated Dose (MTD); Overall Survival

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov