Clinical Trials /

Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer

NCT02138383

Description:

The main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer. Researchers also want to find out the side effects of these drugs when given together. This study will help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine and nab-paclitaxel. In the first part of the study, different doses of enzalutamide will be tested. In the second part of the study, all patients will be started at the same dose of enzalutamide.

Related Conditions:
  • Pancreatic Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Enzalutamide</span> in Combination With <span class="go-doc-concept go-doc-intervention">Gemcitabine</span> and <span class="go-doc-concept go-doc-intervention">Nab-Paclitaxel</span> for the Treatment of Advanced <span class="go-doc-concept go-doc-disease">Pancreatic Cancer</span>

Title

  • Brief Title: Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer
  • Official Title: A Phase I Trial With Cohort Expansion of Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer
  • Clinical Trial IDs

    NCT ID: NCT02138383

    ORG ID: MCC-17696

    Trial Conditions

    Pancreatic Cancer

    Trial Interventions

    Drug Synonyms Arms
    Enzalutamide MDV3100, XTANDI, androgen receptor (AR) antagonist Dose Escalation and Dose Expansion
    Gemcitabine nucleoside inhibitor, GEMZAR Dose Escalation and Dose Expansion
    Nab-paclitaxel albumin bound paclitaxel, microtubule inhibitor, Abraxane Dose Escalation and Dose Expansion

    Trial Purpose

    The main purpose of this study is to find out the dose of enzalutamide that can be safely
    given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer.
    Researchers also want to find out the side effects of these drugs when given together. This
    study will help in finding out the effect on tumor of the combination of enzalutamide,
    gemcitabine and nab-paclitaxel. In the first part of the study, different doses of
    enzalutamide will be tested. In the second part of the study, all patients will be started
    at the same dose of enzalutamide.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Dose Escalation and Dose Expansion Experimental Dose Escalation: To find the dose of enzalutamide that can be safely given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer. Dose Expansion: To find the effect on tumor of the combination of enzalutamide, gemcitabine and nab-paclitaxel. Enzalutamide, Gemcitabine, Nab-paclitaxel

    Eligibility Criteria

    Inclusion Criteria:

    - Participants must have histologically or cytologically confirmed pancreatic
    adenocarcinoma that is metastatic or unresectable. In the dose expansion phase, the
    tumor must express Androgen Receptor (AR) by immunohistochemistry. If 1% of the
    tumor cells express AR, it will be considered positive for this trial.

    - Must have measurable disease per Response Criteria in Solid Tumors (RECIST) criteria
    version 1.1

    - Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%)

    - Life expectancy of greater than 3 months

    - Must have normal organ and marrow function

    - Prior treatment with gemcitabine alone or 5-Fluorouracil with radiation as an
    adjuvant therapy will be allowed; Should not have received gemcitabine within 6
    months of starting the study treatment; 5-Fluorouracil or radiation treatment should
    be received more than 4 weeks prior to receiving the study drug.

    - Women of child-bearing potential and men must agree to use adequate contraception
    prior to study entry and for the duration of study participation. Men treated or
    enrolled on this protocol must also agree to use adequate contraception prior to the
    study, for the duration of study participation, and 4 months after completion of the
    study treatment.

    - Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:

    - Prior treatment with any cytotoxic chemotherapy except as an adjuvant therapy.
    Participant should not have received gemcitabine within 6 months of starting the
    study treatment. 5-Fluorouracil or radiation treatment should be received more than 4
    weeks prior to receiving the study drug.

    - May not be receiving any other investigational agents within 4 weeks of starting the
    study treatment and during the study period.

    - Untreated brain or leptomeningeal metastases, including patients who continue to
    require glucocorticoids for brain or leptomeningeal metastases.

    - History of allergic reactions attributed to compounds of similar chemical or biologic
    composition to gemcitabine, nab-paclitaxel or enzalutamide.

    - Have undergone major surgery within 4 weeks prior to starting the study treatment.

    - Uncontrolled intercurrent illness including, but not limited to ongoing or active
    infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
    arrhythmia, or psychiatric illness/social situations that would limit compliance with
    study requirements; history of myocardial infarction within 6 months of starting
    study treatment.

    - Known history of human immunodeficiency virus (HIV) infection or active hepatitis B
    or hepatitis C

    - Any history of seizure. History of loss of consciousness or transient ischemic attack
    within 12 months of starting the study drug.

    - Women who are pregnant or breast feeding, or women/men able to conceive and unwilling
    to practice an effective method of birth control

    - Chronic treatment with immunosuppressant drugs

    - Other malignancy requiring active treatment

    - Any significant medical condition, laboratory abnormality, or psychiatric illness,
    that would prevent participating in the study, including the inability to swallow
    capsules

    - Any active infection not controlled by antibiotics

    - Concomitant medications that lower seizure threshold

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Maximum Tolerated Dose (MTD)

    Secondary Outcome Measures

    Trial Keywords

    advanced pancreatic cancer

    pancreas

    malignant neoplasm

    endocrine system