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Pancreatic CancerPhase 1NCT04046887

Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)

A Phase 1 study testing Lonsurf, Gemcitabine and Nab-Paclitaxel in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Patrick Joseph Loehrer Sr. at 1 site 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 purpose of this study is to determine the recommended phase 2 dose (RP2D) of the combination of lonsurf, gemcitabine and nab-paclitaxel in Pancreatic ductal adenocarcinoma (PDAC) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lonsurf, Gemcitabine and Nab-Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
11 Sep 2019to 4 Oct 2023
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

  • ≥ 18 years old at the time of informed consent
  • Ability to provide written informed consent and HIPAA authorization
  • Untreated locally advanced Pancreatic Ductal Adenocarcinoma (PDAC) as defined by National Comprehensive Cancer Network (NCCN) guidelines or, untreated metastatic PDAC (prior adjuvant therapy is permitted if it's been greater than 6 months since completion)
  • Histologically or cytologically confirmed PDAC
  • Confirmed PDAC that is measurable or evaluable per RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Show all 21Show fewer
  • Gastrointestinal symptoms (nausea, vomiting, and diarrhea) of Grade 1 or less
  • Adequate organ function as defined by:
  • Aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x upper limits of normal (ULN)
  • Total bilirubin level ≤ 1.5 x ULN
  • Creatinine level < 1.0 x ULN or creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above or below the institutional normal (as determined by Cockcroft-Gault equation). For patients with a Body Mass Index (BMI) > 30 kg/m2, lean body weight should be used to calculate the glomerular filtration rate (GFR).
  • Hemoglobin (Hgb) ≥ 9 g/dl
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Acceptable coagulation studies as demonstrated by prothrombin time (PT) within normal limits (+/-15%) unless they are on anticoagulation therapy
  • Life expectancy estimated at ≥ 3 months
  • Women of childbearing potential definition (WOCBP) must have a negative serum or urine pregnancy test performed within 14 days prior to initiation of study treatment.
  • Any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) is classified as WOCBP if she meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months).
  • WOCBP and men must agree to use adequate contraception prior, to study entry, for the duration of study participation, and 8 weeks after the end of treatment.

Who cannot join

  • Neuropathy > Grade 1 at baseline
  • Prior systemic chemotherapy for any other malignancy (aside from adjuvant therapy for PDAC) in the last 3 years
  • Active malignancy other than PDAC (other than adequately treated cervical or vulvar carcinoma in situ, treated basal cell or squamous carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), ductal carcinoma in situ (DCIS) of the breast and low grade prostate cancer. Any cancer curatively treated >3 years prior to entry with no clinical evidence of recurrence is permitted)
  • Prior exposure to nab-paclitaxel, paclitaxel, or other taxanes
  • History of bowel obstruction in the preceding 3 months of therapy, including gastric outlet obstruction related to PDAC
  • Large, uncontrolled ascites requiring paracentesis
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  • Major surgery, other than diagnostic or laparoscopic surgery, within 4 weeks prior to first dose. (Port placement would not be considered a surgery.)
  • Any known untreated brain metastases including leptomeningeal metastases
  • Pregnant or breastfeeding
  • Significant gastrointestinal disorder(s) that would, in the opinion of the Principal Investigator, prevent absorption of an orally available agent (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection, and small intestinal resection)
  • Uncontrolled chronic diarrhea > Grade 1 at baseline.
  • Uncontrolled intercurrent illness including, but not limited to uncontrolled active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, significant pulmonary disease, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • History of posterior reversible encephalopathy syndrome
  • Enrollment on any additional investigational agent study
  • Known hypersensitivity to gemcitabine or taxanes
  • Significant cardiac disease including the following: unstable angina, New York Heart Association class III-IV congestive heart failure, myocardial infarction < 6 months prior to study enrollment
  • History of hemolytic-uremic syndrome
  • Known infection with Human Immunodeficiency Virus (HIV) and/or active infection with hepatitis B or hepatitis C

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University Melvin & Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Phase I Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

The purpose of this study is to determine the recommended phase 2 dose (RP2D) of the combination of lonsurf, gemcitabine and nab-paclitaxel in Pancreatic ductal adenocarcinoma (PDAC)

Read the detailed description

This is a single-institution, prospective, phase I dose escalation trial of lonsurf combined with gemcitabine and nab-paclitaxel using the 3+3 design. This study will enroll 18 patients over 12-15 months.

Primary Objective To determine the recommended phase 2 dose (RP2D) of the combination of lonsurf, gemcitabine and nab-paclitaxel

Secondary Objectives

  1. Examine safety and toxicity of the combination
  2. Estimate response rate to the combination
  3. Estimate median overall survival (mOS) of the treated population
  4. Estimate median progression free survival (mPFS) of the treated population
  5. Estimate disease control rate (DCR) at 8 weeks
  6. Evaluate quality of life while receiving the combination therapy
Being tested
Lonsurf, Gemcitabine, Nab-Paclitaxel
Keywords
Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Metastatic Pancreatic Cancer, Locally Advanced Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • LonsurfDrug

    Lonsurf will be administered orally twice a day on days 2-6 and 16-20 of every 28-day cycle at a dose of 25 mg/m2, 20 mg/m2 or 30 mg/m2 depending on cohort assignment.

  • GemcitabineDrug

    Gemcitabine will be intravenously administered on Days 1 and 15 of every 28-day cycle at a dose of 800 mg/m2, 600 mg/m2 or 1000 mg/m2 depending on cohort assignment.

  • Nab-PaclitaxelDrug

    Nab-Paclitaxel will be intravenously administered on Days 1 and 15 of every 28-day cycle at a dose of 100 mg/m2, 75 mg/m2 or 125 mg/m2 depending on cohort assignment.

Study groups in NCT04046887
Study groupRoleWhat they receive
Combination of lonsurf + gemcitabine + nab-paclitaxelExperimentalNot described
Receives: Drug: Lonsurf; Drug: Gemcitabine; Drug: Nab-Paclitaxel

What is being measured

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

  1. Frequency of Dose Limiting Toxicities (DLTs)

    Number of DLTs observed

    Measured: 28 days (Cycle 1)

Secondary outcomes (6)

  1. Frequency of adverse events in the safety evaluable population

    safety and toxicity data will be assessed using NCI CTCAE v5.0

    Measured: from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years)

  2. Response rate to the combination of lonsurf, gemcitabine, and nab-paclitaxel in the efficacy evaluable population

    Using RECIST 1.1

    Measured: from start of treatment until treatment discontinuation (i.e. up to 2 years)

  3. Median Overall Survival (mOS) of the treated population

    Measured: from start of treatment until death or last known follow up (i.e up to 2 years)

  4. Median Progression-free Survival (mPFS) of the treated population

    Measured: from start of treatment until disease progression or last follow up (i.e. up to 2 years)

  5. Disease control rate (DCR)

    Disease control rate (DCR) as defined by (complete response + partial response + stable disease)

    Measured: 8 weeks

  6. European Organization for Research and Treatment of Cancer quality of life questionnaire

    Scale scores were calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.

    Measured: Day 1 of each cycle(each cycle is 28 days),from start of treatment until disease progression or discontinuation of treatment (i.e. up to 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 posted6 Aug 2019
  2. Study start11 Sep 2019
  3. Primary completion10 May 2021
  4. Study completion4 Oct 2023

Why it stopped: Unable to proceed due to Neulasta difficulties and other complications.

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Initially 3 patients will be enrolled to the starting cohort. If 1 of 3 patients experience a dose-limiting toxicity (DLT) in the first cycle, then an additional 3 evaluable patients will be accrued to that dose level. Dose reductions are not permitted during cycle 1. If 2 or more patients in a cohort experience a DLT, then the previous dose will be considered the recommended phase 2 dose (PR2D) and dose escalation will terminate. Dose escalation will proceed according to the scheme above only after all patients (3 or 6 evaluable patients, depending on the incidence of DLT) have been followed for at least 1 full cycle. Once dose escalation has been completed, if only 2 dose levels were used to determine the RP2D and depending on how many patients were replaced, additional patients will be enrolled at the RP2D in order to obtain data for 18 patients total.
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04046887
Sponsor's protocol ID
IUSCC-0664
Status last verified
Jan 2024
First submitted
1 Aug 2019
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lonsurf, Gemcitabine and Nab-Paclitaxel in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Patrick Joseph Loehrer Sr. 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 21 inclusion and 19 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 5 Jan 2024. 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 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 was stopped early (reason given: Unable to proceed due to Neulasta difficulties and other complications.). Results are not available in the source record.

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?

Frequency of Dose Limiting Toxicities (DLTs) (time frame: 28 days (Cycle 1)). 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 NCT04046887.

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 5 Jan 2024.

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