Solid TumorsPhase 1NCT02379416
Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors
A Phase 1 study testing Nilotinib + Paclitaxel in people with Solid Tumors, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 120 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Nilotinib + Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2015to 25 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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 study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study drug administration.
- Patients must have completed radiation therapy, or major surgery greater than or equal to 3 weeks, or biologic therapy or chemotherapy greater than or equal to 5 half-lives or 3 weeks, whichever is shorter (6 weeks for nitrosoureas and mitomycin C) prior to entering the study. Patients must be greater than or equal to 2 weeks since any prior administration of a study drug in a Phase 0 or equivalent study and be greater than or equal to1 week from palliative radiation therapy. Patients must have recovered to eligibility levels from prior toxicity or adverse events. Treatment with bisphosphonates is permitted.
- For the PD-expansion cohort, patients must be willing to give biopsies for research and have tumors amenable for the acceptable biopsy procedures- or in lieu of baseline biopsies, patient must have and be willing to submit at registration archival tumor biopsy tissue from a previous research study or medical care. Criteria for the submission of archival tissue are:
- Tissue must have been collected within 3 months prior to registration.
- Patient must not have received any intervening therapy for their cancer since the collection of the tumor sample.
- Tumor tissue must meet the minimum requirements
Who cannot join
- QTcF interval of less than 450 msec at study entry; congenital long QT syndrome
- Sensory/motor neuropathy less than or equal to Grade 2
- Patients who are receiving any other investigational agents.
- Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial. Patients with treated brain metastases, whose brain metastatic disease has remained stable for less than or equal to 4 weeks without requiring steroid and anti-seizure medication are eligible to participate.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs.
- Uncontrolled intercurrent illness including, but not limited to, serious untreated infection, symptomatic respiratory failure/congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Pregnant women are excluded from this study because nilotinib and paclitaxel have been assigned to pregnancy category D by the FDA. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 3 months following the last dose of study drug.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of possible PK interactions with study drugs.
- Both men and women of all races and ethnic groups are eligible for this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Phase I Trial of the Combination of Nilotinib and Paclitaxel in Adults and Pediatric Patients With Refractory Solid Tumors
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.
Read more
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.
Read the detailed description
Background:
-The BCR-Abl kinase inhibitor nilotinib demonstrated greater than additive activity in combination with the anti-tubulin agent paclitaxel in preclinical xenograft models, justifying the clinical evaluation of this combination for its antitumor activity
Objectives:
- To establish the safety, tolerability, and maximum tolerated dose (MTD) of nilotinib plus paclitaxel in patients with refractory solid tumors, both in adult subjects >=18 years of age and in pediatric/adolescent subjects 12-17 years of age
- To determine the pharmacokinetics of paclitaxel and nilotinib when administered in combination
- To evaluate the pharmacodynamic effects of the combination on biomarkers of apoptosis, DNA damage response, and epithelial-to-mesenchymal transition
Eligibility:
- Study participants must have histologically confirmed solid tumor that has progressed on standard therapy known to prolong survival or for which no standard treatment options exist
- Age greater than or equal to 12
- No major surgery, radiation, or chemotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas and mitomycin C).
- Adequate organ function
Study Design:
- This is an open-label Phase I trial
- During dose escalation, the starting dose of nilotinib will be administered at 300 mg orally BID from cycle 1 day 2 and paclitaxel will be administered IV at 60 mg/m2 at dose level 1 on Days 1, 8, and 15 in 28-day cycles. For cycle 2 on, nilotinib will be administered from day 1. Dose escalation will follow a 3+3 design, with dose limiting toxicities defined during cycle 1.
- Up to 33 adult patients will be accrued to a PD expansion phase at the MTD to further assess pharmacodynamic endpoints in tumor and CTCs.
- As of Amendment O (May 2020), patients ages 12-17 will be accrued to a separate pediatric expansion cohort to evaluate the safety, pharmacokinetics, and pharmacodynamics of this combination for pediatric patients.
- Conditions
- Solid Tumors
- Being tested
- Nilotinib + Paclitaxel
- Keywords
- Drug Efflux, Taxanes, Combination, Bcr-Abl Kinase Inhibitors, Neoplasms
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nilotinib + PaclitaxelDrug
The BCR-Abl kinase inhibitor nilotinib demonstrated greater than additive activity in combination with the anti-tubulin agent paclitaxel in preclinical xenograft models, justifying the clinical evaluation of this combination for its antitumor activity
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | The starting dose of nilotinib will be administered at 300 mg orally BID from cycle 1 day 2 and paclitaxel will be administered IV at 60 mg/m2 at dose level 1 on Days 1, 8, and 15 in 28-day cycles. For cycle 2 on, nilotinib will be administered from day 1. Dose escalation will follow a 3+3 design, with dose limiting toxicities defined during cycle 1. Receives: Drug: Nilotinib + Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the safety, tolerability, and maximum tolerated dose (MTD) of nilotinib plus paclitaxel combination in patients with refractory solid tumors
Safety, tolerability, and maximum tolerated dose (MTD) of nilotinib plus paclitaxel combination in patients with refractory solid tumors
Measured: Cycle 1
Secondary outcomes (1)
To determine the pharmacokinetics of paclitaxel when administered in combination with nilotinib
Measured: Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study start13 Apr 2015
- Primary completion30 Apr 2025
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Alice P Chen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379416
- Sponsor's protocol ID
- 150086
- Other IDs
- 15-C-0086
- Status last verified
- 17 Apr 2026
- First submitted
- 4 Mar 2015
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kummar S, Chen HX, Wright J, Holbeck S, Millin MD, Tomaszewski J, Zweibel J, Collins J, Doroshow JH. Utilizing targeted cancer therapeutic agents in combination: novel approaches and urgent requirements. Nat Rev Drug Discov. 2010 Nov;9(11):843-56. doi: 10.1038/nrd3216. Epub 2010 Oct 29.
PubMed 21031001Tiwari AK, Sodani K, Dai CL, Abuznait AH, Singh S, Xiao ZJ, Patel A, Talele TT, Fu L, Kaddoumi A, Gallo JM, Chen ZS. Nilotinib potentiates anticancer drug sensitivity in murine ABCB1-, ABCG2-, and ABCC10-multidrug resistance xenograft models. Cancer Lett. 2013 Jan 28;328(2):307-17. doi: 10.1016/j.canlet.2012.10.001. Epub 2012 Oct 9.
PubMed 23063650Shen T, Kuang YH, Ashby CR, Lei Y, Chen A, Zhou Y, Chen X, Tiwari AK, Hopper-Borge E, Ouyang J, Chen ZS. Imatinib and nilotinib reverse multidrug resistance in cancer cells by inhibiting the efflux activity of the MRP7 (ABCC10). PLoS One. 2009 Oct 20;4(10):e7520. doi: 10.1371/journal.pone.0007520.
PubMed 19841739
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of the Combination of Nilotinib and Paclitaxel in Adults and Pediatric Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT02379416
- Acronym / sponsor ID
- 150086
- Conditions
- Solid Tumors
- Keywords
- Drug Efflux, Taxanes, Combination, Bcr-Abl Kinase Inhibitors, Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 13 Apr 2015 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
-The BCR-Abl kinase inhibitor nilotinib demonstrated greater than additive activity in combination with the anti-tubulin agent paclitaxel in preclinical xenograft models, justifying the clinical evaluation of this combination for its antitumor activity
Objectives:
- To establish the safety, tolerability, and maximum tolerated dose (MTD) of nilotinib plus paclitaxel in patients with refractory solid tumors, both in adult subjects >=18 years of age and in pediatric/adolescent subjects 12-17 years of age
- To determine the pharmacokinetics of paclitaxel and nilotinib when administered in combination
- To evaluate the pharmacodynamic effects of the combination on biomarkers of apoptosis, DNA damage response, and epithelial-to-mesenchymal transition
Eligibility:
- Study participants must have histologically confirmed solid tumor that has progressed on standard therapy known to prolong survival or for which no standard treatment options exist
- Age greater than or equal to 12
- No major surgery, radiation, or chemotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas and mitomycin C).
- Adequate organ function
Study Design:
- This is an open-label Phase I trial
- During dose escalation, the starting dose of nilotinib will be administered at 300 mg orally BID from cycle 1 day 2 and paclitaxel will be administered IV at 60 mg/m2 at dose level 1 on Days 1, 8, and 15 in 28-day cycles. For cycle 2 on, nilotinib will be administered from day 1. Dose escalation will follow a 3+3 design, with dose limiting toxicities defined during cycle 1.
- Up to 33 adult patients will be accrued to a PD expansion phase at the MTD to further assess pharmacodynamic endpoints in tumor and CTCs.
- As of Amendment O (May 2020), patients ages 12-17 will be accrued to a separate pediatric expansion cohort to evaluate the safety, pharmacokinetics, and pharmacodynamics of this combination for pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: Nilotinib + PaclitaxelThe starting dose of nilotinib will be administered at 300 mg orally BID from cycle 1 day 2 and paclitaxel will be administered IV at 60 mg/m2 at dose level 1 on Days 1, 8, and 15 in 28-day cycles. For cycle 2 on, nilotinib will be administered from day 1. Dose escalation will follow a 3+3 design, with dose limiting toxicities defined during cycle 1. |
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (9 listed)
- QTcF interval of less than 450 msec at study entry; congenital long QT syndrome
- Sensory/motor neuropathy less than or equal to Grade 2
- Patients who are receiving any other investigational agents.
- Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial. Patients with treated brain metastases, whose brain metastatic disease has remained stable for less than or equal to 4 weeks without requiring steroid and anti-seizure medication are eligible to participate.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nilotinib + PaclitaxelThe BCR-Abl kinase inhibitor nilotinib demonstrated greater than additive activity in combination with the anti-tubulin agent paclitaxel in preclinical xenograft models, justifying the clinical evaluation of this combination for its antitumor activity | Drug | treatment |
Primary outcome
To establish the safety, tolerability, and maximum tolerated dose (MTD) of nilotinib plus paclitaxel combination in patients with refractory solid tumors
Time frame: Cycle 1
Safety, tolerability, and maximum tolerated dose (MTD) of nilotinib plus paclitaxel combination in patients with refractory solid tumors
1 secondary outcome
To determine the pharmacokinetics of paclitaxel when administered in combination with nilotinib
Time frame: Cycle 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 21031001Kummar S, Chen HX, Wright J, Holbeck S, Millin MD, Tomaszewski J, Zweibel J, Collins J, Doroshow JH. Utilizing targeted cancer therapeutic agents in combination: novel approaches and urgent requirements. Nat Rev Drug Discov. 2010 Nov;9(11):843-56. doi: 10.1038/nrd3216. Epub 2010 Oct 29.
- Background: PubMed 23063650Tiwari AK, Sodani K, Dai CL, Abuznait AH, Singh S, Xiao ZJ, Patel A, Talele TT, Fu L, Kaddoumi A, Gallo JM, Chen ZS. Nilotinib potentiates anticancer drug sensitivity in murine ABCB1-, ABCG2-, and ABCC10-multidrug resistance xenograft models. Cancer Lett. 2013 Jan 28;328(2):307-17. doi: 10.1016/j.canlet.2012.10.001. Epub 2012 Oct 9.
- Background: PubMed 19841739Shen T, Kuang YH, Ashby CR, Lei Y, Chen A, Zhou Y, Chen X, Tiwari AK, Hopper-Borge E, Ouyang J, Chen ZS. Imatinib and nilotinib reverse multidrug resistance in cancer cells by inhibiting the efflux activity of the MRP7 (ABCC10). PLoS One. 2009 Oct 20;4(10):e7520. doi: 10.1371/journal.pone.0007520.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice P Chen, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nilotinib + Paclitaxel in people with Solid Tumors, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the safety, tolerability, and maximum tolerated dose (MTD) of nilotinib plus paclitaxel combination in patients with refractory solid tumors (time frame: Cycle 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02379416, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.