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Trial record 1 of 2 for:    am0010 folfox
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Study of AM0010 With FOLFOX Compared to FOLFOX Alone Second-line Tx in Pts With Metastatic Pancreatic Cancer (Sequoia)

This study is currently recruiting participants.
Verified November 2017 by ARMO BioSciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02923921
First Posted: October 5, 2016
Last Update Posted: November 30, 2017
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.
Information provided by (Responsible Party):
ARMO BioSciences
  Purpose
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 Intervention Phase
Pancreatic Cancer Biological: AM0010 Drug: FOLFOX Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by ARMO BioSciences:

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

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

Estimated Enrollment: 566
Study Start Date: November 2016
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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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
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): NCT02923921


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

  Show 125 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 Submitted: September 30, 2016
First Posted: October 5, 2016
Last Update Posted: November 30, 2017
Last Verified: November 2017

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