RECRUITING

Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors

Conditions

Solid Tumors Drug Efflux Taxanes Combination Bcr-Abl Kinase Inhibitors Neoplasms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase I Trial of the Combination of Nilotinib and Paclitaxel in Adults and Pediatric Patients With Refractory Solid Tumors

Quick Facts

Study Start:2015-04-13

Study Completion:2026-06-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02379416

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 120 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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	* 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. * 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.

Inclusion Criteria

Exclusion 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 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

* 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.
* 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.

Contacts and Locations

Study Contact

DTC Referral Coordinators

CONTACT

(240) 781-3400

dtcreferralcoordinators@nih.gov

Alice P Chen, M.D.

CONTACT

(240) 781-3320

chenali@mail.nih.gov

Principal Investigator

Alice P Chen, M.D.

PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Alice P Chen, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-04-13

Study Completion Date2026-06-27

Study Record Updates

Study Start Date2015-04-13

Study Completion Date2026-06-27

Terms related to this study

Keywords Provided by Researchers

Drug Efflux
Taxanes
Combination
Bcr-Abl Kinase Inhibitors
Neoplasms

Additional Relevant MeSH Terms

Solid Tumors