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Study of AM0010 With FOLFOX Compared to FOLFOX Alone Second-line Tx in Pts With Metastatic Pancreatic Cancer (Sequoia)

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ClinicalTrials.gov Identifier: NCT02923921
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
ARMO BioSciences

September 30, 2016
October 5, 2016
June 14, 2018
November 2016
January 2019   (Final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 36 months after the last patient randomized ]
Same as current
Complete list of historical versions of study NCT02923921 on ClinicalTrials.gov Archive Site
  • Progression Free Survival [ Time Frame: 36 months after the last patient randomized ]
  • Objective Response Rate [ Time Frame: 36 months after the last patient randomized ]
Same as current
Not Provided
Not Provided
 
Study of AM0010 With FOLFOX Compared to FOLFOX Alone Second-line Tx in Pts With Metastatic Pancreatic Cancer
Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Meta Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen
To compare the efficacy of AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic pancreatic cancer as measured by overall survival
This is an open-label, multi-center, randomized, Phase 3 study designed to compare the efficacy and safety of AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic adenocarcinoma of the pancreas who have progressed on one prior gemcitabine containing regimen.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cancer
  • Biological: AM0010
    AM0010 plus FOLFOX
  • Drug: FOLFOX
    FOLFOX Alone
    Other Names:
    • oxaliplatin
    • 5-FU
    • leucovorin
  • Experimental: ARM 1
    AM0010 (5 μg/kg) dosed on Days 1-5 and Days 8-12 SQ plus FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles or until disease progression.
    Interventions:
    • Biological: AM0010
    • Drug: FOLFOX
  • Active Comparator: ARM 2
    FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles or until disease progression.
    Intervention: Drug: FOLFOX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
566
Same as current
January 2020
January 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. The presence of metastatic pancreatic adenocarcinoma
  2. Measurable disease per RECIST v.1.1
  3. Patient must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan
  4. Eastern Cooperative Oncology Group Performance Status of 0 - 1
  5. Patient must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
  6. Patients must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
  7. Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
  8. No peripheral neuropathy
  9. No known history of dihydropyrimidine dehydrogenase deficiency

Exclusion Criteria:

  1. Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
  2. Patient on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
  3. Patient has received prior treatment with AM0010 or fluoropyrimidine/platinum containing regimen
  4. Patients who were intolerant of a gemcitabine containing regimen.
  5. History of positivity for human immunodeficiency virus
  6. Chronic active or active viral hepatitis A, B, or C infection
  7. Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)
  8. Pregnant or lactating women
  9. Patients with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
  10. Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks
  11. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period
  12. Prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Study Director 650-771-9325 AM0010-301@armobio.com
Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Ireland,   Italy,   Korea, Republic of,   Poland,   Spain,   Taiwan,   United Kingdom,   United States
 
 
NCT02923921
AM0010-301
Yes
Not Provided
Not Provided
ARMO BioSciences
ARMO BioSciences
Not Provided
Not Provided
ARMO BioSciences
June 2018

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