Enzalutamide In Combination With Gemcitabine And Nab-Paclitaxel For The Treatment Of Advanced Pancreatic Cancer

Study Overview

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.

N/A

Pancreatic Cancer

DRUG: Enzalutamide
DRUG: Gemcitabine
DRUG: Nab-paclitaxel

MCC-17696

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-05-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-08-16
First Submitted that Met QC Criteria 2014-05-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-08-17
First Posted (ACTUAL) 2014-05-14	Results First Posted N/A	Last Verified 2021-08

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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 na	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 pa DRUG: Gemcitabine The starting dose of gemcitabine will be 1000 mg/m^2 administered intravenously on days 1, 8 and 15 of each cycle. 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.

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 na

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 pa

DRUG: Gemcitabine

The starting dose of gemcitabine will be 1000 mg/m^2 administered intravenously on days 1, 8 and 15 of each cycle.

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.

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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Astellas Pharma Inc

Investigators

PRINCIPAL_INVESTIGATOR: Richard Kim, M.D., H. Lee Moffitt Cancer Center and Research Institute

Publications

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

General Publications

No publications available

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