Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer (NCT02635672) | Clinical Trial Compass
CompletedPhase 1
Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer
United States, Chile, Spain110 participantsStarted 2016-02-10
Plain-language summary
Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) as monotherapy or in combination in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).
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.
Part 2 (Global), Part 3 (US Only), and Part 4 (US Only)
Inclusion Criteria:
* Male or female patients aged \>/=18 years
* Patients with a histologically or cytologically confirmed solid tumor or aggressive NHL who are refractory to or have exhausted all available therapies with MYC expression or known C-MYC amplification/alterations
* Adequate bone marrow, liver, and renal functions
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
In the addition to the above Part 3 (US Only) and Part 4 (US Only)
* Must be eligible to use pembrolizumab per USPI
Exclusion Criteria:
* Active clinically serious infections of events \> Grade 2
* Subjects who have new or progressive brain or meningeal or spinal metastases.
* Anticancer chemotherapy or immunotherapy during the study or within 1 weeks prior to the first dose of study drug
* Major surgery or significant trauma within 4 weeks before the first dose of study drug
* Allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment.
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
Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152)
Timeframe: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
2
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP152 (BAY1251152)
Timeframe: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
3
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP152 (BAY1251152)
Timeframe: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
4
AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of VIP152 (BAY1251152)
Timeframe: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
5
Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval (Cmax,md) of VIP152 (BAY1251152)
Timeframe: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days
6
AUC from time 0 to the last data point > LLOQ after multiple dosing [AUC(0-tlast)md] of VIP152 (BAY1251152)