Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies

Withdrawn before enrolling · Phase 2

Conditions studied: Hematologic Malignancies

In brief

This is a phase II, single arm, unblinded study of ceritinib in patients with rel/ref hematologic malignancies. Up to 24 evaluable subjects will be enrolled with an interim analysis for efficacy after the first 9 subjects are enrolled. Any subject who takes at least one dose of study drug will be evaluable for safety. Only subjects who complete at least 1 cycle of study drug and have clear progression on physical exam or have had at least one restaging study will be considered evaluable for response. Each subject will receive the same dose of 750mg po daily at the study entry. Subjects with stable disease or better will be allowed to continue study drug until disease progression or until intolerable adverse events or patient or physician decision. Intrapatient dose reductions will be allowed for adverse events. This is a multicenter study with Duke as the lead site. Blood and tissue samples, will be collected and used for exploratory analysis.

Key facts

Study ID: NCT02343679
Run by: Anne Beaven, MD
People needed: 0
Starts: 2015-05-01
Expected to finish: 2022-10-01
Last updated by the study team: 2017-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Alk+R/R hematologic malignancy including but not limited to ALK+ALCL or ALK+LBCL > 1 prior standard cytotoxic regimen
Age >18
ECOG performance status <2
Evidence of measurable or evaluable disease
Toxicities ≤ grade 2 due to prior therapies Exception: any grade alopecia
Platelets >75 x 109/L
ANC>1.5 x 109/L
AST/ALT<3.0 x ULN, except liver involvement by their lymphoma, include if AST/ALT<5 x ULN.
Total Bilirubin<1.5 x ULN, (includes gilbert's syndrome if total bilirubin <3.0 x ULN and direct bilirubin <1.5 x ULN)
Potassium, magnesium, total calcium and phosphorous > lower limits of normal
Calculated or measured CrCl> 30ml/min
Ability to provide written informed consent
Willing/able to comply with scheduled visits, treatment plans, laboratory tests and other procedures
Women/men of reproductive potential must agree to use effective birth control during study and for 3 months after receiving study drug.
Must have existing tissue available for correlative studies

You may not qualify if…

No chemotherapy, radiation or surgical resection of malignancy < 3 weeks before start of study drug
Prior therapy with other ALK inhibitor investigational agents except crizotinib
Active, uncontrolled, serious infection or medical or psychiatric illness likely to interfere with trial
Known HIV infection
Extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, (history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis or clinically significant radiation pneumonitis) i.e. affecting daily living or requiring ongoing therapeutic intervention.
Symptomatic CNS metastases and neurologically unstable or increasing doses of steroids < 2 weeks prior to study entry
Major surgery 4 weeks before initiating protocol therapy.
Hypersensitivity to microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide, magnesium stearate
Diagnosis or treatment for malignancy other than NHL < 3 years before Day 1 of protocol therapy. Exceptions:
Basal or squamous cell carcinoma of the skin
In situ malignancy - completely resected.
Prostate cancer treated with prostatectomy or radiotherapy > 2 years before Day 1 of protocol therapy and PSA is undetectable
In situ malignancy - completely resected
Current treatment with another investigational agent < 14 days before enrollment. Other non-treatment studies allowed if it won't interfere with study participation.
Myocardial infarction or unstable angina 6 months before enrollment or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
o QTcF>450msec
Oral steroids > 4mg dexamethasone or equivalent/day excluding steroids used for adrenal insufficiency
Impaired GI function from significant small bowel resection or gastric bypass surgery or inability to swallow up to five ceritinib capsules daily
Ongoing GI adverse events > grade 2 (e.g. nausea, vomiting, or diarrhea) at start of study.
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to start of treatment and for the duration of participation:
Medication with a significant known risk of prolonging the QT interval or inducing Torsades de Pointes http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm
Strong inhibitors or strong inducers of CYP3A4/5 http://medicine.iupui.edu/flockhart/table.htm or http://www.druginteractioninfo.org
Therapeutic doses of warfarin sodium (Coumadin) or coumadin-derived anti-coagulant.
Enzyme-inducing anticonvulsive agents
Herbal supplements

Where it is running

Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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