A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma
Condition: Pancreatic Ductal Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Abemaciclib; LY3023414; Gemcitabine; Capecitabine
Intervention description: Administered orally; Administered orally; Administered IV; Administered orally
Intervention MeSH terms: Gemcitabine; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pancreatic cancer

Summary:

      The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in
      combination with other drugs versus standard of care in participants with previously treated
      metastatic pancreatic ductal adenocarcinoma (PDAC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of ductal adenocarcinoma of the pancreas.

          -  Metastatic disease with documented disease progression following previous treatment
             with at least one, but no more than 2 prior therapies, with one of the prior therapies
             having been either gemcitabine-based or fluoropyrimidine-based therapy. Neoadjuvant
             and/or adjuvant therapies for localized resectable or unresectable PDAC each count as
             a line of therapy if multiagent chemotherapy regimens were administered (and
             neoadjuvant regimen was different than adjuvant regimen) and if the participant
             progressed with metastatic disease while taking or within 6 months of completion of
             (neo)adjuvant therapy.

          -  Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Participant for whom treatment with monotherapy chemotherapy such as gemcitabine or
             capecitabine is a reasonable choice.

          -  Discontinued all prior treatment for cancer at least 14 days prior to initial dose of
             study treatment.

          -  Adequate organ function.

               -  allow alanine aminotransferase (ALT) or aspartate aminotransferase (AST) up to 5x
                  upper limit of normal (ULN) if liver metastases.

               -  allow bilirubin up to 2.5 times ULN if elevation is not associated with other
                  signs of liver toxicity or can be explained by mechanical obstruction - requires
                  clinical research physician approval.

        Exclusion Criteria:

          -  Have a personal history of any of the following conditions: syncope of either
             unexplained or cardiovascular etiology, ventricular arrhythmia (including but not
             limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac
             arrest. Exception: Participants with controlled atrial fibrillation for >30 days prior
             to study treatment initiation are eligible.

          -  Have insulin-dependent diabetes mellitus. Participants with type 2 diabetes mellitus
             are eligible if adequate control of blood glucose level is obtained by oral
             anti-diabetics as documented by hemoglobin A1c (HbA1c) <7%.

          -  Have symptomatic central nervous system metastasis. Screening of asymptomatic
             participants is not required for enrollment.

          -  Have had major surgery within 7 days prior to initiation of study drug to allow for
             postoperative healing of the surgical wound and site(s).

          -  Have previously received treatment with any cyclin-dependent kinase (CDK) 4 and 6
             inhibitor or phosphatidylinositol 3-kinase (PI3K) and/or mammalian target of rapamycin
             (mTOR) inhibitor or have a known hypersensitivity to any component of the
             investigational products in this study.

          -  Have a known hypersensitivity to investigator's choice of standard of care
             (gemcitabine or capecitabine).