A Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer
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| ClinicalTrials.gov Identifier: NCT02210559 |
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Recruitment Status :
Active, not recruiting
First Posted : August 6, 2014
Last Update Posted : February 15, 2019
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Sponsor:
FibroGen
Information provided by (Responsible Party):
FibroGen
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Cancer (Unresectable) | Drug: FG-3019 Drug: Gemcitabine Drug: Nab-paclitaxel | Phase 1 Phase 2 |
Each subject may receive up to six cycles of treatment (each treatment cycle is 28 days). Tumor tissue will be collected during resection for biomarker analysis. EUS core tumor biopsies will be collected pre/post treatment at participating centers. Tumor response will be evaluated by changes in CT scan, FDG-PET, CA 19-9, and NCCN® guidelines.
Subjects who complete 6 cycles of treatment will be evaluated for surgical exploration for possible R0 resection. Subjects who undergo surgery will be evaluated for surgical complications for an additional 30 days following discharge from surgery. All subjects will be followed for safety for 28 days following their last dose with study drug. Blood samples will be collected periodically for the assessment of pharmacokinetics (PK) and pharmacodynamics (PD).
All subjects, including those who discontinue from the study during the treatment period without evidence of disease progression, will be followed for at least 28 weeks post End of Treatment for disease progression, survival, and follow-on treatment for pancreatic cancer.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 37 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | July 2014 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | December 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pancreatic Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A
FG-3019 + Gemcitabine + Nab-paclitaxel
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Drug: FG-3019
FG-3019 is administered in TREATMENT ARM A ONLY 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 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.
Other Name: Gemzar Drug: Nab-paclitaxel 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 Name: Abraxane |
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Arm B
Gemcitabine + Nab-paclitaxel
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Drug: Gemcitabine
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.
Other Name: Gemzar Drug: Nab-paclitaxel 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 Name: Abraxane |
Primary Outcome Measures :
- Safety [ Time Frame: Through 28 days following the last dose of study treatment ]Asses the treatment-emergent adverse events (TEAEs), serious treatment-emergent adverse events (TESAEs), clinical laboratory tests, and discontinuation of treatment for treatment-related TEAEs.
- Surgical safety with respect to complication rates post resection [ Time Frame: 30 days following discharge after surgery ]
- The proportion of subjects who become eligible for surgery [ Time Frame: After completion of 24 weeks of treatment with study drug ]
- The proportion of subjects in whom R0 resection is achieved [ Time Frame: After completion of 24 weeks of treatment with study drug ]
- The proportion of subjects in R0 or R1 resection is achieved [ Time Frame: After completion of 24 weeks of treatment with study drug ]
- Tumor response rates [ Time Frame: After completion of 24 weeks of treatment with study drug ]Measured by: complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), at least 50% reduction from baseline in serum CA19-9, or at least 30% reduction from baseline in SUV[max] assessed by FDG-PET
- Median overall survival and 1-year survival rate [ Time Frame: At least 28 weeks following completion of 24 weeks of treatment (52 weeks) ]
- Median progression free survival and 1-year progression free rate [ Time Frame: At least 28 weeks following completion of 24 weeks of treatment (52 weeks) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Male or non-pregnant, non-lactating female
- Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
- Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per NCCN criteria)
- Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted
- Measurable disease as defined by RECIST 1.1
- 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 SMA > 180°
- Previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer or in situ carcinoma of the cervix)
- Major surgery within 4 weeks prior to Day 1 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 subject in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.
- Current abuse of alcohol or drugs
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210559
Locations
| United States, Arizona | |
| HonorHealth Research Institute | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| University of California, Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| United States, District of Columbia | |
| Georgetown University - Medstar Health Research Institute | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Mayo Clinic Florida | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Minnesota | |
| Virginia Piper Cancer Institute | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Pennsylvania | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Washington | |
| Virginia Mason Medical Center - Benaroya Research Institute | |
| Seattle, Washington, United States, 98101 | |
Sponsors and Collaborators
FibroGen
Investigators
| Principal Investigator: | Vincent Picozzi, MD | Virginia Mason Medical Center - Benaroya Research Institute |
Additional Information:
| Responsible Party: | FibroGen |
| ClinicalTrials.gov Identifier: | NCT02210559 History of Changes |
| Other Study ID Numbers: |
FGCL-3019-069 |
| First Posted: | August 6, 2014 Key Record Dates |
| Last Update Posted: | February 15, 2019 |
| Last Verified: | February 2019 |
Keywords provided by FibroGen:
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locally advanced pancreatic |
cancer unresectable pancreatic cancer |
Additional relevant MeSH terms:
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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Paclitaxel Albumin-Bound Paclitaxel Gemcitabine Antibodies, Monoclonal Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |