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

August 16, 2021 updated by: H. Lee Moffitt Cancer Center and Research Institute

A Phase I Trial With Cohort Expansion of Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation and Dose Expansion

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.
Drug: Enzalutamide
The starting dose of enzalutamide will be 80 mg (Level 1) daily, taken orally. The dose escalation schedule is a standard 3 + 3 design. 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.
Other Names:
  • MDV3100
  • XTANDI®
  • androgen receptor (AR) antagonist
Drug: Gemcitabine
The starting dose of gemcitabine will be 1000 mg/m^2 administered intravenously on days 1, 8 and 15 of each cycle.
Other Names:
  • GEMZAR®
  • nucleoside inhibitor
Drug: Nab-paclitaxel
The starting dose of nab-paclitaxel will be 125 mg/m^2 administered intravenously on days 1, 8 and 15 of each cycle.
Other Names:
  • Abraxane®
  • albumin bound paclitaxel
  • microtubule inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD)
Time Frame: Up to 18 months
To determine the maximally tolerated dose (MTD) of enzalutamide in combination with gemcitabine and nab-paclitaxel in advanced pancreatic cancer.
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2014

Primary Completion (Actual)

December 15, 2016

Study Completion (Actual)

October 7, 2019

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 14, 2014

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-17696

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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