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Trial record 6 of 8 for:    pamrevlumab

Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Gemcitabine and Nab-paclitaxel) in Locally Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03941093
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
FibroGen

Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date August 26, 2020
Actual Study Start Date  ICMJE May 10, 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
  • Overall Survival (OS) [ Time Frame: Randomization to death due to any cause or until the last subject to complete treatment reaches 18 months post-treatment ]
  • Proportion of all randomized subjects in whom R0 or R1 resection is achieved [ Time Frame: After completion of 24 weeks of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
  • Progression-free survival (PFS) [ Time Frame: Randomization until the last subject to complete treatment reaches 18 months post-treatment. ]
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 Version 3.0). [ Time Frame: Baseline through safety follow up (~4 weeks post-last dose) ]
    The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome
  • Patient-Reported Outcomes National Cancer Institute Common Terminology Criteria for Adverse Events (PRO CTCAE) Severity and Interference Items (decreased appetite, nausea, vomiting, diarrhea, abdominal pain and fatigue) [ Time Frame: Baseline through safety follow up (~4 weeks post-last dose) ]
    6 item questionnaire with 1-3 questions per item related to frequency, severity and interference
    • Frequency answers range from Never to Almost Constantly
    • Severity answers range from None to Very Severe
    • Interference answers range from Not at all to Very much.
    • PRO-CTCAE responses are scored from 0 to 4, and there are no standardized scoring rules yet established for how to combine attributes into a single score or how best to analyse PRO-CTCAE data longitudinally.
    • PRO-CTCAE scores for each attribute (frequency, severity and/or interference) will be presented descriptively
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
  • Progression-free survival (PFS) [ Time Frame: Randomization until the last subject to complete treatment reaches 18 months post-treatment. ]
  • Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) [ Time Frame: Baseline through safety follow up (~4 weeks post-last dose) ]
  • Change from baseline in selected Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) items (Decreased appetite, Nausea, Vomiting, Diarrhea, Abdominal pain) [ Time Frame: Baseline through safety follow up (~4 weeks post-last dose) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Gemcitabine and Nab-paclitaxel) in Locally Advanced Pancreatic Cancer
Official Title  ICMJE A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in Combination With Gemcitabine Plus Nab-paclitaxel (G/NP) as Neoadjuvant Treatment in Patients With Locally Advanced, Unresectable Pancreatic Cancer
Brief Summary This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with gemcitabine plus nab-paclitaxel (G/NP) in the treatment of locally advanced, unresectable pancreatic cancer subjects.
Detailed Description

Subjects will be randomized in a 1:1 ratio to one of the two study treatment arms; pamrevlumab with G/NP or placebo with G/NP.

Each subject may receive up to six cycles of treatment (each treatment cycle is 28 days). Tumor tissue will be collected during resection to determine surgical outcome and for biomarker analysis. Tumor response will be evaluated by changes in CT scan, FDG-PET, CA 19-9, and NCCN® guidelines.

All subjects randomized will have a safety follow-up visit approximately 28 days after the last dose of study treatment.

Subjects who complete 6 cycles of treatment will be evaluated for surgical exploration for possible R0 or R1 resection. Surgery will occur at least 4 weeks after the last dose (allowing for a wash-out period from treatment) and only after receipt of the recommendation from the central review board with regards to surgical eligibility. Surgery will occur no longer than 8 weeks after the last dose. Subjects who undergo surgery will be evaluated for surgical complications for at least an additional 90 days following discharge from surgery.

Subjects who are ineligible for surgical exploration (i.e. subjects who did not complete 6 cycles of treatment or do not meet any of the protocol defined criteria or had a contraindication to surgery) will continue in the Follow-up period and receive treatment as per standard of care (SOC) for each institution.

All subjects will be followed for disease progression (if not previously detected) or recurrence following resection (local progression or metastatic disease). Subjects will also be followed for any additional anti-cancer therapy received for their pancreatic cancer. All subjects will be followed for survival (until death) or until the last subject to complete treatment reaches 18 months post-treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be randomized in a 1:1 ratio to one of the two study treatment arms; pamrevlumab with G/NP or placebo with G/NP.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer Non-resectable
Intervention  ICMJE
  • Drug: Pamrevlumab + Gemcitabine + Nab-paclitaxel

    Drug: Pamrevlumab is administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. The dose level is 35 mg/kg.

    Drug: Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. The dose level is 1000 mg/m2.

    Drug: Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. The dose level is 125 mg/m2.

    Other Names:
    • FG-3019
    • Gemzar
    • Abraxane
  • Drug: Placebo + Gemcitabine + Nab-paclitaxel

    Drug: Placebo is administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion.

    Drug: Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. The dose level is 1000 mg/m2.

    Drug: Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. The dose level is 125 mg/m2.

    Other Names:
    • Gemzar
    • Abraxane
Study Arms  ICMJE
  • Experimental: Arm A
    Pamrevlumab + Gemcitabine + Nab-paclitaxel
    Intervention: Drug: Pamrevlumab + Gemcitabine + Nab-paclitaxel
  • Placebo Comparator: Arm B
    Placebo + Gemcitabine + Nab-paclitaxel
    Intervention: Drug: Placebo + Gemcitabine + Nab-paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2019)
256
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Understand and sign informed consent; be willing to comply with study procedures, including surgery
  2. Age ≥ 18 years
  3. Be a male, or non-pregnant and non-lactating female
  4. Negative serum B-hCG pregnancy test at screening for women of childbearing potential
  5. Male subjects with partners of childbearing potential and female subjects of childbearing potential are required to use double barrier contraception methods during the conduct of the study and for 3 months after the last dose of study drug
  6. Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
  7. Locally advanced pancreatic cancer considered unresectable according to NCCN Guidelines® Version 2.2018 as determined by central imaging
  8. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors RECIST 1.1 criteria as determined by central imaging
  9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  10. Adequate liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x upper limit of normal (ULN), alkaline phosphatase <2.5 x ULN, and bilirubin ≤1.5 x ULN
  11. Adequate bone marrow function: platelets >100,000 cells/mm3, hemoglobin >9.0 g/dl and absolute neutrophil count (ANC) >1,500 cells/mm3
  12. Adequate renal function: creatinine < 1.5 x ULN, creatinine clearance ≥ 30 mL/min
  13. Less than grade 2 pre-existing peripheral neuropathy (per CTCAE)

Exclusion Criteria:

  1. Prior chemotherapy or radiation for pancreatic cancer
  2. Previous (within the past 3 years) or concurrent malignancy diagnosis except non-melanoma skin cancer and in situ carcinomas (excluding in situ breast cancer)
  3. Major surgery within 4 weeks prior to signing informed consent form. Biliary stents are permitted.
  4. History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
  5. Any medical or surgical condition that may place the subject at increased risk while on study
  6. Any condition potentially decreasing compliance to study procedures
  7. Exposure to another investigational drug within 28 days of first dosing visit, or 5 half-lives of the investigational drug (whichever is longer)
  8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infections, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  9. Documented history of drug or alcohol abuse within 6 months of signing informed consent
  10. Any medical condition that, in the opinion of the investigator, may pose a safety risk to a subject in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mairead Carney 415-978-1337 lapis@fibrogen.com
Listed Location Countries  ICMJE Austria,   Canada,   France,   Israel,   Italy,   Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941093
Other Study ID Numbers  ICMJE FGCL-3019-087
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party FibroGen
Study Sponsor  ICMJE FibroGen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account FibroGen
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP