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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 : January 5, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To compare the efficacy of AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic pancreatic cancer as measured by overall survival

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: AM0010 Drug: FOLFOX Phase 3

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 566 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Biological: AM0010
AM0010 plus FOLFOX
Drug: FOLFOX
FOLFOX Alone
Other Names:
  • oxaliplatin
  • 5-FU
  • leucovorin
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.
Drug: FOLFOX
FOLFOX Alone
Other Names:
  • oxaliplatin
  • 5-FU
  • leucovorin


Outcome Measures

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 36 months after the last patient randomized ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 36 months after the last patient randomized ]
  2. Objective Response Rate [ Time Frame: 36 months after the last patient randomized ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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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): NCT02923921


Contacts
Contact: Study Director 650-771-9325 AM0010-301@armobio.com

  Show 128 Study Locations
Sponsors and Collaborators
ARMO BioSciences
More Information

Responsible Party: ARMO BioSciences
ClinicalTrials.gov Identifier: NCT02923921     History of Changes
Other Study ID Numbers: AM0010-301
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Oxaliplatin
Antineoplastic Agents