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NCT Number: NCT02210559

A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer

This is a Phase 1/2 trial to evaluate the safety, tolerability, and efficacy of FG-3019 administered with gemcitabine and nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.

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Key information

Conditions

Pancreatic Cancer (Unresectable) Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

HonorHealth Research Institute, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Male, or non-pregnant and, non-lactating female
  • Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
  • Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per National Comprehensive Cancer Network® [NCCN®] criteria)
  • Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted.
  • Measurable disease as defined by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate liver, bone marrow, and renal function
  • Agree to use contraception per protocol
  • Less than Grade 2 pre-existing peripheral neuropathy

Key Exclusion Criteria:

  • Prior chemotherapy or radiation for pancreatic cancer
  • Solid tumor contact with superior mesenteric artery (SMA) >180°
  • Previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer and in situ carcinomas)
  • Major surgery, within 4 weeks prior to Day 1 on study
  • History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
  • Exposure to another investigational drug within 42 days of first dosing visit, or 5 half-lives of the study product (whichever is longer)
  • Uncontrolled intercurrent illness
  • Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a participant in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.
  • Current abuse of alcohol or drugs

Treatment and study plan

FG-3019

Drug

FG-3019 will be administered per dose and schedule specified in the arm group description.

Gemcitabine

Drug

Gemcitabine will be administered per dose and schedule specified in the arm group description.

Other names: Gemzar

Nab-paclitaxel

Drug

Nab-paclitaxel will be administered per dose and schedule specified in the arm group description.

Other names: Abraxane

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: From first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196)

    An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as a new or worsening AE that occurred in the window of first infusion of any study drug (Day 1) and within 28 days of the last infusion of study drug or the day before surgery, whichever occurred first. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.

  2. Number of Participants Who Had Surgical Complications Post-Resection

    Time frame: 30 days following discharge after surgery (up to Day 198)

    Number of participants who had surgical complications (for example; surgical site infection, intra-abdominal abscess, or perioperative leak during surgery) has been reported

Secondary outcomes

  1. Number of Participants Who Became Eligible for Surgery

    Time frame: After completion of 24 weeks of treatment with study drug

  2. Number of Participants in Whom R0 Resection Was Achieved

    Time frame: After completion of 24 weeks of treatment with study drug

    R0 resection was determined by pathological examination of the surgical specimen after resection.

  3. Number of Participants in Whom R0 or R1 Resection Was Achieved

    Time frame: After completion of 24 weeks of treatment with study drug

    R0 or R1 resection was determined by pathological examination of the surgical specimen after resection.

  4. Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Time frame: From randomization up to Week 52

    CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduced in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  5. Median Overall Survival

    Time frame: From randomization until death from any cause, assessed up to 4 years

    Overall survival was defined as the time from randomization until death from any cause.

  6. Median Progression-Free Survival

    Time frame: From randomization until objective tumor progression or death, assessed up to 4 years

    Progression-free survival was defined as the time from randomization until objective tumor progression or death. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Sponsors and collaborators

Lead sponsor

Kyntra Bio

Industry

Registry information

Official study title

A Randomized, Open Label, Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2014
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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