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Pharmatech Lilly J1L-AM-JZGB

Status:

Available | Phase III

Official Title:

A Randomized Phase 3 Study of AM0010 in Combination with FOLFOX Compared with FOLFOX Alone as Second-line Therapy in Patients with Metastatic Pancreatic Cancer that has Progressed During or Following a First-Line Gemcitabine Containing Regimen

Study Purpose:

To determine if an investigational drug, AM0010, in combination with an approved chemotherapy regimen, FOLFOX (oxaliplatin plus 5-fluorouracil (5-FU) plus leucovorin), is safe and effective in the treatment of patients with metastatic pancreatic cancer that has progressed during or following a first-line Gemcitabine containing regimen, compared with FOLFOX alone.

Interventions:

Arm 1: AM0010 (study agent) under the skin injections for 5 days followed by a 2 day break, and FOLFOX standard chemotherapy in your vein for up to 6 months (12 cycles)

ARM 2: FOLFOX alone for up to 6 months (12 cycles)

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Pancreatic adenocarcinoma

Eligibility:

One prior treatment line including a gemcitabine based regimen

Scheduled for second line FOLFOX

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

Pharmatech Lilly J1L-AM-JZGB

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today.