A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Ag… (NCT02627274) | Clinical Trial Compass
CompletedPhase 1
A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)
United States, Belgium, Canada134 participantsStarted 2015-12-07
Plain-language summary
This first-in-human, open-label, multicenter, Phase Ia/Ib, adaptive, multiple ascending-dose study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RO6874281 as a single agent (Part A) or in combination with trastuzumab or cetuximab (Part B or C).
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:
* Radiologically measurable and clinically evaluable disease
* Absence of rapid disease progression or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention
* Confirmed at least one tumor lesion with location accessible to safely biopsy per clinical judgment (special requirements apply for Part C; Participants with only one target lesion and no non-target lesions can enroll after documented agreement with the Medical Monitor).
* Life expectancy of greater than or equal to (\>=12) weeks
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Participants with unilateral pleural effusion (other than non-small cell lung cancer \[NSCLC\] indication) should fulfill the following criteria for pulmonary and cardiac functions: Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification 0 - 1 level and New York Heart Association (NYHA) classification class 1 or better
* Forced expiratory volume 1 (FEV1) \>70% and forced vital capacity (FVC) \>70% of predicted value; participants with lung metastases should present with DLCO \>60% of predicted value
* Adequate cardiovascular, hematological, liver and renal function
* All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to grade less than or equal to (\<=) 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
* Negative serum pregnancy test within 7 days prior to study treatme…
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
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Timeframe: Day 1 up to Day 21
2
Maximum Tolerated Dose (MTD) of RO6874281
Timeframe: Day 1 up to Day 21
3
Optimal Biological Dose (OBD) of RO6874281
Timeframe: Day 1 up to Day 21
4
Recommended Dose for Further Development of RO6874281
Timeframe: Day 1 up to Day 21
5
Systemic Clearance (CL) of RO6874281
Timeframe: Day 1 up to 24 months
6
Volume of Distribution at Steady State (Vss) of RO6874281
Timeframe: Day 1 up to 24 months
7
Area Under the Concentration-Time Curve (AUC) of RO6874281