1911GCCC: Galeterone or Galeterone With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    58
  • sponsor
    University of Maryland, Baltimore
Updated on 21 February 2022

Summary

Assess the effectiveness of galeterone in advanced pancreatic adenocarcinoma

Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of galeterone, an investigational drug, in pancreatic cancer.

The FDA (the U.S. Food and Drug Administration) has not approved galeterone for pancreatic cancer. Galeterone is an androgen receptor inhibitor that showed anti-cancer activity in pancreatic cancer in research lab. In this study, the investigator is interested in evaluating galeterone alone or in combination with chemotherapy in treating pancreatic cancer.

Details
Condition Advanced Pancreatic Cancer
Treatment Gemcitabine, galeterone
Clinical Study IdentifierNCT04098081
SponsorUniversity of Maryland, Baltimore
Last Modified on21 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Ability to understand and willingness to sign a written informed consent document
Agree to comply with the study requirements and agrees to come to the clinic/hospital for required study visits
18 years of age or order
Histologic or cytologic diagnosis of pancreatic adenocarcinoma
Measurable metastatic disease documented by CT/MRI at least 1cm in greatest dimension
Have received 2 lines of prior systemic therapy; those patients must demonstrate continued disease progression (RECIST 1.1) and must not have received chemotherapy for at least 4 weeks prior to trial assignment
ECOG performance status must be 0-2 (Appendix A)
All participants (male and female) with reproductive potential must practice an effective method of contraception while on this study in order to minimize risks to fetuses
Men and women of all ethnic groups are eligible for this trial
Able to swallow up to six pills and retain oral medication
Expected life expectancy of more than 12 weeks
Patient has adequate bone marrow function as demonstrated by the following blood
counts at Baseline (obtained 14 days prior to randomization)
Absolute neutrophil count (ANC) 1.5 109/L
Platelet count 100,000/mm3 (100 109/L)
Hemoglobin (Hgb) 8 g/dL
Patient has adequate organ functions at baseline (obtained 14 days prior to randomization)
AST (SGOT), ALT (SGPT) 2.5 upper limit of normal range (ULN)
Total bilirubin 1.2mg/dl
Serum creatinine within normal limits or calculated clearance 50 mL/min. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For patients with a Body Mass Index (BMI) >30 kg/m2, adjusted body weight should be used instead
Patients with well controlled oligo brain metastasis are eligible Ability to understand and willingness to sign a written informed consent document
Agree to comply with the study requirements and agrees to come to the clinic/hospital for required study visits
18 years of age or order
Histologic or cytologic diagnosis of stage IV pancreatic adenocarcinoma
Measurable disease per RECIST 1.1 criteria
Have received 2 lines of prior systemic therapy; those patients must demonstrate continued disease progression (RECIST 1.1) and must not have received chemotherapy for at least 4 weeks prior to trial assignment
ECOG performance status must be 0-2 (Appendix A)
All participants (male and female) with reproductive potential must agree to be abstinent or practice an effective method of contraception while on this study in order to minimize risks to fetuses
Men and women of all ethnic groups are eligible for this trial
Able to swallow up to six pills and retain oral medication
Expected life expectancy of more than 12 weeks

Exclusion Criteria

Participation in another clinical trial involving experimental therapy for pancreatic adenocarcinoma within 4 weeks prior to enrollment or simultaneous participation in a study involving investigational treatment
Prior anti-cancer therapy
Prior treatment with galeterone, or anti-androgens
Prior radiation therapy within 4 weeks (if single fraction of radiotherapy within 2 weeks)
Concurrent use of other anti-cancer agents
Major surgery within 4 weeks prior to randomization
The following medical conditions
New York Heart Association Class III or IV congestive heart failure
Myocardial infarction/unstable angina (within the 6 months prior to randomization)
History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia)
History of long QT syndrome, Mobitz II second or third degree heart block without a permanent pacemaker in place
Bradycardia as defined by heart rate of <50 beats/minute at Screening ECG
History of chronic or active Hepatitis B or Hepatitis C or other known chronic liver disease. Patients recovered from hepatitis are not excluded from the study
Known human immunodeficiency virus (HIV) infection
Uncontrolled hypertension (defined as systolic blood pressure > 170 mmHg or diastolic blood pressure of > 105 mmHg measured on at least two occasions, two weeks apart) despite acceptable anti-hypertension therapy
Hypotension (defined as systolic blood pressure <90 mmHg)
History of adrenal insufficiency or hyperaldosteronism
Gastrointestinal disorders or gastric bypass surgery, with the exception of pancreatic cancer and its complications, including lap bands that could interfere with the absorption of galeterone
Serious active infections requiring systemic treatment or nonmalignant medical illnesses that are uncontrolled
History of seizure or any condition or concomitant use of any medication that may predispose to seizure or lower the seizure threshold
History of loss of consciousness or transient ischemic attack within 12 months of randomization
History of (in the past 5 years) other malignancy, other than curatively treated nonmelanomatous skin cancer and superficial transitional cell carcinoma of the bladder
Cranial/spinal epidural disease
The patient has known allergy to any of the treatment components
Any physical or mental condition or social situation that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the trial procedures, confound the ability to interpret data from the study or places the patient at unacceptable risk if he participates in this study
Current alcohol abuse or illicit drug use
Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded
Females at reproductive age must have a negative urine pregnancy test prior to entry to this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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