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Boston Biomedical CanStem111P

Status:

Recruiting | Phase III

Official Title:

A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Adult Pancreatic Adenocarcinoma

Study Purpose:

To determine if adding BBI-608 to standard treatment will help subjects with metastatic pancreatic cancer live longer than those who only receive standard treatment.

Interventions:

  • Chemotherapy: Nab-paclitaxel (Abraxane), Gemcitabine (Gemzar)
  • Quality of Life questionnaires
  • Arm I: Take oral drug every day starting 3 to 5 days prior to start of chemotherapy. Chemotherapy will occur once weekly for 3 weeks and then off for one week
  • Arm II: Chemotherapy will occur once weekly for 3 weeks and then off for one week

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Histology- Advanced Pancreatic Adenocarcinoma that is metastatic

Eligibility:

No prior treatment for metastatic disease 

One or more metastatic tumors that are measureable

Must have a performance status of 0 or 1

Cannot require help with activities of daily living including eating, dressing, etc

Both males and females of child-bearing potential must agree to use contraception during study treatment and for 180 days following

Meet acceptable laboratory values prior to treatment

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

Methodist Health System Trial Code:

Boston Biomedical CanStem111P

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!