Study of IDO Inhibitor in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer

Not Recruiting

Trial ID: NCT02077881


This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. All subjects will receive the same standard gemcitabine plus nab-paclitaxel regimen, plus indoximod in doses increasing from 600 mg twice daily to, potentially, 1200 mg twice daily.

Official Title

A Phase I/II Study of Indoximod in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Adenocarcinoma of the Pancreas

Stanford Investigator(s)

Hans-Christoph Becker, MD, FSABI, FSCCT

Clinical Professor, Radiology

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine


Inclusion Criteria:

   - Patient has definitive histologically or cytologically confirmed metastatic
   adenocarcinoma of the pancreas. Patients with islet cell or neuroendocrine neoplasms
   are excluded.

   - Initial diagnosis of metastatic disease must have occurred ≤8 weeks prior to entry in
   the study.

   - Patient has one or more metastatic tumors measurable per RECIST 1.1 by CT scan ≤4
   weeks prior to entry into the study

   - Male or non-pregnant and non-lactating female, and ≥18 years of age.

   - Patients must have received no previous radiotherapy, surgery, chemotherapy or
   investigational therapy for the treatment of metastatic disease.

   - Prior treatment with gemcitabine and/or nab-paclitaxel in the adjuvant setting is
   allowed, provided at least 6 months have elapsed since completion of the last dose and
   no lingering toxicities are present.

   - Patients cannot have received any other immunomodulatory therapies (including
   vaccines) as treatment for this or any other cancer.

   - Patient has a Karnofsky performance status (KPS) ≥ 70.

   - Patients should be asymptomatic for jaundice prior to Day 1.

Exclusion Criteria:

   - Patients may not be receiving (or received prior to enrollment) any other
   investigational agents for metastatic disease.

   - Patient has known brain metastases,

   - Patient has only locally advanced disease.

   - Lymph node only metastases even if considered M1 disease by official staging criteria.

   - History of malignancy in the last 3 years. Patients with prior history of in situ
   cancer or basal or squamous cell skin cancer are eligible. Patients with other
   malignancies are eligible if they were cured by surgery alone or surgery plus
   radiotherapy and have been continuously disease-free for at least 3 years.

   - Patients with any active autoimmune disease

   - Patient has undergone major surgery, other than diagnostic surgery (ie, surgery done
   to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to
   Day 1 of treatment in this study.


drug: Nab-Paclitaxel

drug: Gemcitabine

drug: Indoximod

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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