Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138383
Recruitment Status : Active, not recruiting
First Posted : May 14, 2014
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Enzalutamide Drug: Gemcitabine Drug: Nab-paclitaxel Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 22, 2014
Actual Primary Completion Date : December 15, 2016
Estimated Study Completion Date : December 2019


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:
  • nucleoside inhibitor
  • GEMZAR®

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:
  • albumin bound paclitaxel
  • microtubule inhibitor
  • Abraxane®




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138383


Locations
Layout table for location information
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Astellas Pharma Inc
Investigators
Layout table for investigator information
Principal Investigator: Richard Kim, M.D. H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02138383     History of Changes
Other Study ID Numbers: MCC-17696
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
advanced pancreatic cancer
pancreas
malignant neoplasm
endocrine system
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs