PEN-866 in Patients With Advanced Solid Malignancies (NCT03221400) | Clinical Trial Compass
UnknownPhase 1/2
PEN-866 in Patients With Advanced Solid Malignancies
United States340 participantsStarted 2017-08-29
Plain-language summary
Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.
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
. M/F at least 18 years old
. Performance status 0 or 1
. Adequate bone marrow, liver, and kidney function within 28 days prior to first dose
. Serum potassium, calcium, magnesium, phosphorus within normal limits
. Adequate birth control
. Central venous access line is required
. Patients in Phase 1a must also have confirmed advanced solid malignancy that has progressed after one or more prior lines of anticancer therapy and no other standard of care therapies that are deemed appropriate for treatment of their malignancy
. Patients in Phase 2a must have measurable disease per RECIST 1.1 and documented disease progression during or after their most recent line of anticancer therapy.
Exclusion criteria
. Treatment with anticancer therapy or investigational drug or device within 2 wk (6 wk for nitrosureas or mitomycin C) before C1D1, and any drug-related toxicities must have recovered to grade 1 or less with the exception of alopecia and peripheral neuropathy.
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.
What they're measuring
1
Phase 1a and 1b : Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: Patients will be followed for 28 days to determine the incidence of DLTs.
2
All Phases: Incidence of treatment related adverse events (Safety and tolerability)
Timeframe: From date of first treatment/trial entry up to 28 days following the last treatment.
3
Phase 2a: Efficacy of PEN-866 in patients with SCLC using best overall response rate
Timeframe: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
4
Phase 2a: Efficacy of PEN-866 in patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma using best overall response rate
Timeframe: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
5
Phase 2a: Efficacy of PEN-866 in patients with pancreatic adenocarcinoma using Disease Control Rate (DCR)
Timeframe: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
6
Phase 2a: Efficacy of PEN-866 in patients with endometrial adenocarcinoma using best overall response rate
. Phase 2a only: Prior treatment with topoisomerase I inhibitor(s).
. Cardiac disease such as unstable angina within 6 months of screening, myocardial infarction within 6 months of screening, NY Heart Association Class III - IV heart failure, QTc greater than 470 msec, congenital long Qt syndrome, symptomatic orthostatic hypotension within 6 months of screening, uncontrolled hypertension, or clinically important abnormalities in heart rhythm, conduction, morphology of resting ECG.
For Phase 1b patients receiving the Niraparib combination only: hypertension as defined as diastolic \> 90 mmHg or systolic \> 140 mmHg
. Stroke or transient ischemic attack within 6 months of screening
. Prior history of posterior reversible excephalopathy scyndrome (PRES).
. Peripheral neuropathy greater than grade 2
. Patients requiring medications with drugs that are inhibitors of UGT1A1 or substrates of CYP1A2, P-gP, BCRP, OATP1B1, OATP1B3 or OCT1 transporters
Timeframe: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
7
Phase 2a: Efficacy of PEN-866 in patients with squamous cell carcinoma of the genitalia (anus, cervix, vulva, or penis) using best overall response rate
Timeframe: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months