1911GCCC: Galeterone With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma (NCT04098081) | Clinical Trial Compass
Active — Not RecruitingPhase 2
1911GCCC: Galeterone With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma
United States15 participantsStarted 2019-12-12
Plain-language summary
Assess the effectiveness of galeterone in advanced pancreatic adenocarcinoma
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Major surgery within 4 weeks prior to randomization.
. The following medical conditions:
. 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.