Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors (NCT02379416) | Clinical Trial Compass
CompletedPhase 1
Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors
United States47 participantsStarted 2015-04-13
Plain-language summary
Background:
\- Researchers want to find better ways to treat cancer. One drug that treats cancer is paclitaxel. Sometimes proteins block that drug from working. Researchers want to see if another drug, nilotinib, helps paclitaxel work better.
Objective:
\- To test the safety of nilotinib plus paclitaxel and find out what doses of the drugs can be given safely to people.
Eligibility:
\- Adults at least 18 years old with advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists.
Design:
* Participants will be screened with tests they usually get in their cancer care: medical history, physical exam, blood and urine tests, heart test, and scans.
* Participants will take the two study drugs in 28-day cycles. They will keep a medicine diary.
* Nilotinib will be taken by mouth twice every day except day 1 of the first cycle.
* Paclitaxel will be given by IV once a week for the first 3 weeks of a cycle. This will usually be done at the clinic.
* Most participants will have a weekly study visit every week for cycle 1, then the first 3 weeks of other cycles. They will have:
* Physical exam at every visit.
* Blood tests multiple times for cycle 1, then the first 3 weeks of other cycles.
* Scans every 8 weeks. These may be CT or MRI scans, in a machine that takes pictures. Or they may be ultrasounds, where a wand is pressed on the skin with gel on it.
* Around 30 days after stopping the study drugs, participants will be called to discuss any side effects.
Who can participate
Age range
12 Years – 120 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:
* Patients must have histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist.
* Age greater than or equal to 12 years.
* ECOG performance status less than or equal to 2.
* Life expectancy of greater than 3 months
* Patients must have normal organ and marrow function as defined below:
* Absolute neutrophil count greater than or equal to 1,500/mcL
* Platelets greater than or equal to 100,000/mcL
* Total bilirubin less than or equal to 1.5 X institutional ULN (with the exception of those with Gilbert syndrome, who must have total bilirubin \<=3 X institutional ULN)
* AST(SGOT)/ALT(SGPT) less than or equal to 3 X institutional upper limit of normal; 5.0 x ULN in patients with liver metastases
* creatinine less than or equal to 1.5 X institutional ULN OR
* creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels greater than 1.5 mg/dL
* Nilotinib and paclitaxel have both been assigned to pregnancy category D by the FDA. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for at least 3 months after dosing with study drugs ceases. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this s…
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.
1Since this was a Phase 1 trial focused on finding a safe dose rather than proving the treatment works, what do the results tell us about whether this nilotinib and paclitaxel combination actually helped patients with solid tumors like mine?
2This trial has already been completed — does that mean the results are published, and if so, what did they find about the maximum tolerated dose and side effects of combining nilotinib with paclitaxel?
3Nilotinib is typically used for leukemia and paclitaxel is a chemotherapy — what's the reasoning behind combining them for my type of solid tumor, and is this combination now being tested further in a Phase 2 trial?
4Since this study enrolled patients with refractory solid tumors, meaning standard treatments had already stopped working, would you recommend I try remaining standard options first before considering an experimental combination like this?
5What serious side effects were reported in this trial, and how do they compare to the risks of other treatment options you might consider for my situation?
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
To establish the safety, tolerability, and maximum tolerated dose (MTD) of nilotinib plus paclitaxel combination in patients with refractory solid tumors