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History of Changes for Study: NCT02227940
Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer
Latest version (submitted July 20, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 26, 2014 None (earliest Version on record)
2 January 23, 2015 Recruitment Status, Arms and Interventions, Study Status, Contacts/Locations, Conditions and Oversight
3 February 25, 2015 Study Description, Study Status, Eligibility, Arms and Interventions, Study Design and Conditions
4 June 15, 2015 Arms and Interventions, Outcome Measures, Study Status, Eligibility, Study Description and Oversight
5 July 21, 2015 Study Status and Sponsor/Collaborators
6 July 28, 2015 Eligibility, Study Description, Sponsor/Collaborators and Study Status
7 August 14, 2015 Study Status and Sponsor/Collaborators
8 September 1, 2015 Study Description, Study Status and Sponsor/Collaborators
9 March 1, 2016 Study Status
10 August 16, 2016 Contacts/Locations and Study Status
11 September 28, 2016 Study Status, Contacts/Locations, Arms and Interventions and Conditions
12 November 1, 2016 Study Status
13 March 28, 2017 Study Status
14 April 11, 2017 Study Status, Arms and Interventions, Contacts/Locations and Conditions
15 April 24, 2017 Study Status
16 June 21, 2017 Study Status
17 October 5, 2017 Study Status
18 December 26, 2017 Study Status
19 February 20, 2018 Study Status
20 June 14, 2018 Study Status
21 December 3, 2018 Study Status
22 January 31, 2019 Study Status
23 March 26, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
24 April 4, 2019 Study Status
25 February 4, 2020 Recruitment Status and Study Status
26 March 3, 2020 Study Status
27 July 20, 2022 Sponsor/Collaborators, Study Status and Study Identification
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Study NCT02227940
Submitted Date:  August 26, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: I 248813
Brief Title: Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer
Official Title: A Phase I Study of Ceritinib (LDK378), a Novel ALK Inhibitor, in Combination With Gemcitabine-Based Chemotherapy in Patients With Advanced Solid Tumors
Secondary IDs: NCI-2014-01766 [Registry Identifier: CTRP (Clinical Trial Reporting Program)]
I 248813 [Roswell Park Cancer Institute]
P30CA016056 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: August 2014
Overall Status: Not yet recruiting
Study Start: September 2014
Primary Completion: June 2017 [Anticipated]
Study Completion:
First Submitted: August 26, 2014
First Submitted that
Met QC Criteria:
August 26, 2014
First Posted: August 28, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 26, 2014
Last Update Posted: August 28, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Roswell Park Cancer Institute
Responsible Party: Sponsor
Collaborators: National Cancer Institute (NCI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This phase I trial studies the side effects and best dose of ceritinib and combination chemotherapy in treating patients with advanced solid tumors or pancreatic cancer that has spread to other parts of the body. Ceritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ceritinib and more than one drug (combination chemotherapy) may be a better treatment for solid tumors or pancreatic cancer.
Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of ceritinib in combination with gemcitabine (gemcitabine hydrochloride) alone, gemcitabine/nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) and gemcitabine/cisplatin in patients with advanced solid malignancies.

SECONDARY OBJECTIVES:

I. Characterize the safety profile of ceritinib in combination with gemcitabine based chemotherapy in advanced solid malignancies.

II. Determine the pharmacokinetic profile of ceritinib, gemcitabine, nab-paclitaxel, cisplatin and their metabolites when administered in combination in patients with advanced solid tumors.

III. Determine the preliminary efficacy of the study combinations.

TERTIARY OBJECTIVES:

I. Explore tumor biomarkers of efficacy to the study combination.

OUTLINE: This is a dose-escalation study of ceritinib. Patients are assigned to 1 of 3 treatment arms.

ARM I (ADVANCED SOLID TUMORS): Patients receive ceritinib orally (PO) once daily (QD) on days 1-28 and gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II (ADVANCED PANCREATIC CANCER): Patients receive ceritinib PO QD on days 1-28, gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, and paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM III (ADVANCED SOLID TUMORS): Patients receive ceritinib PO QD on days 1-28, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and cisplatin IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

EXPANSION COHORT: Once the MTD of ceritinib has been determined, patients with anaplastic lymphoma kinase positive (ALK+) solid tumors are assigned to 1 of 3 treatment regimens.

ARM IA: Patients who previously progressed on gemcitabine hydrochloride-based therapy receive ceritinib and gemcitabine hydrochloride as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM IIA: Patients receive ceritinib, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation as in Arm II. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM IIIA: Patients receive ceritinib, gemcitabine hydrochloride, and cisplatin as in Arm III. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for at least 4 weeks.

Open or close this module Conditions
Conditions: Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 6
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 108 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm I (ceritinib, gemcitabine hydrochloride)
Patients receive ceritinib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: ceritinib
Given PO
Other Names:
  • LDK378
  • Zykadia
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Experimental: Arm II (ceritinib, gemcitabine hydrochloride, nab-paclitaxel)
Patients receive ceritinib PO QD on days 1-28, gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, and paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: ceritinib
Given PO
Other Names:
  • LDK378
  • Zykadia
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
Other Names:
  • ABI-007
  • nab paclitaxel
  • nab-paclitaxel
  • nanoparticle albumin-bound paclitaxel
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Experimental: Arm III (ceritinib, gemcitabine hydrochloride, cisplatin)
Patients receive ceritinib PO QD on days 1-28, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and cisplatin IV on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: ceritinib
Given PO
Other Names:
  • LDK378
  • Zykadia
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
laboratory biomarker analysis
Correlative studies
Experimental: Arm IA (ceritinib, gemcitabine hydrochloride)
Patients who previously progressed on gemcitabine hydrochloride-based therapy receive ceritinib and gemcitabine hydrochloride as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: ceritinib
Given PO
Other Names:
  • LDK378
  • Zykadia
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Experimental: Arm IIA (ceritinib, gemcitabine hydrochloride, nab-paclitaxel)
Patients receive ceritinib, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation as in Arm II. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: ceritinib
Given PO
Other Names:
  • LDK378
  • Zykadia
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
Other Names:
  • ABI-007
  • nab paclitaxel
  • nab-paclitaxel
  • nanoparticle albumin-bound paclitaxel
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Experimental: Arm IIIA (ceritinib, gemcitabine hydrochloride, cisplatin)
Patients receive ceritinib, gemcitabine hydrochloride, and cisplatin as in Arm III. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: ceritinib
Given PO
Other Names:
  • LDK378
  • Zykadia
Drug: gemcitabine hydrochloride
Given IV
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Open or close this module Outcome Measures
Primary Outcome Measures:
1. MTD and RP2D of ceritinib in combination with gemcitabine hydrochloride alone, defined as the highest dose level at which < 2 of 6 patients experience treatment-related dose limiting toxicity (DLT) (Arms I and IA)
[ Time Frame: Up to day 28 ]

Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v)4.0. The frequency of toxicities will be tabulated for the dose estimated to be the MTD.
2. MTD and RP2D of ceritinib in combination with gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation, defined as the highest dose level at which < 2 of 6 patients experience treatment-related DLT (Arms II and IIA)
[ Time Frame: Up to day 28 ]

Graded according to NCI CTCAE v4.0. The frequency of toxicities will be tabulated for the dose estimated to be the MTD.
3. MTD and RP2D of ceritinib in combination with gemcitabine hydrochloride and cisplatin, defined as the highest dose level at which < 2 of 6 patients experience treatment-related DLT (Arms III and IIIA)
[ Time Frame: Up to day 28 ]

Graded according to NCI CTCAE v4.0. The frequency of toxicities will be tabulated for the dose estimated to be the MTD.
Secondary Outcome Measures:
1. Incidence of adverse events of ceritinib in combination with gemcitabine hydrochloride based chemotherapy in advanced solid malignancies according to NCI CTCAE v4.0
[ Time Frame: Up to 4 weeks after end of treatment ]

Overall safety profile characterized by type, frequency, severity, timing, seriousness and relationship to study treatment. The frequency of toxicities will be tabulated by grade across all dose levels and cycles.
2. Pharmacokinetic parameters of ceritinib and gemcitabine hydrochloride when administered in combination in patients with advanced solid tumors (Arms I and IA)
[ Time Frame: Pre-dose, 0.5, 1-2, 4-5, 6-8, and 24 hours (day 1 of courses 1-2), pre-dose on day 15 of course 1 (ceritinib); prior to end of infusion, 0.5, 1-2, and 4-6 hours post-end of infusion (day 1 of courses 1-2) (gemcitabine hydrochloride) ]

A population pharmacokinetic model will be developed utilizing the pharmacokinetic time points collected, and then used to estimate individual area under the curve (AUC)s or clearance (CL) of ceritinib in combination with gemcitabine hydrochloride. The effects of the cytotoxics on ceritinib pharmacokinetic will be evaluated by the model, along with other patient factors that may explain the interpatient variability in pharmacokinetics, including AUC and observed maximum concentration (Cmax).
3. Pharmacokinetic parameters of ceritinib, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation when administered in combination in patients with advanced solid tumors (Arms II and IIA)
[ Time Frame: Pre-dose, 0.5, 1-2, 4-5, 6-8, and 24 hours (day 1 of courses 1-2), pre-dose on day 15 of course 1 (ceritinib); prior to end of infusion, 0.5, 1-2, and 4-6 hours post-end of infusion (day 1 of courses 1-2) (gemcitabine hydrochloride and nab-paclitaxel) ]

A population pharmacokinetic model will be developed utilizing the pharmacokinetic time points collected, and then used to estimate individual AUCs or CL of ceritinib in combination with gemcitabine hydrochloride and nab-paclitaxel. The effects of the cytotoxics on ceritinib pharmacokinetic will be evaluated by the model, along with other patient factors that may explain the interpatient variability in pharmacokinetics, including AUC and observed Cmax.
4. Pharmacokinetic parameters of paclitaxel albumin-stabilized nanoparticle formulation, and cisplatin when administered in combination in patients with advanced solid tumors
[ Time Frame: Pre-dose, 0.5, 1-2, 4-5, 6-8, and 24 hours (day 1 of courses 1-2), pre-dose on day 15 of course 1 (ceritinib); prior to end of infusion, 0.5, 1-2, and 4-6 hours post-end of infusion (day 1 of courses 1-2) (gemcitabine hydrochloride and cisplatin) ]

A population pharmacokinetic model will be developed utilizing the pharmacokinetic time points collected, and then used to estimate individual AUCs or CL of ceritinib in combination with gemcitabine hydrochloride and cisplatin. The effects of the cytotoxics on ceritinib pharmacokinetic will be evaluated by the model, along with other patient factors that may explain the interpatient variability in pharmacokinetics, including AUC and observed Cmax.
5. Response rate as assessed by the RECIST 1.1
[ Time Frame: Up to 4 weeks after end of treatment ]

Objective tumor response will be tabulated overall (and by dose level if appropriate).
6. Progression free survival
[ Time Frame: Up to 4 weeks after end of treatment ]

Other Outcome Measures:
1. Levels of serum and tumor biomarkers
[ Time Frame: Up to 4 weeks after end of treatment ]

The relationship between ALK positivity and antitumor effects will be analyzed descriptively and simple statistics if need to.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Arm 1: histologically or cytologically confirmed solid tumors that are advanced that gemcitabine-based treatment is considered a clinically appropriate option
  • Arm 2: histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic
  • Arm 3: histologically or cytologically confirmed solid tumors that are advanced that gemcitabine plus cisplatin treatment is considered a clinically appropriate option
  • Arms 1A, 2A and 3A: solid tumor that demonstrate anaplastic lymphoma kinase (ALK) positivity; ALK positivity can be assessed using the assays below, and documentation of ALK positivity using one of the tests below is required
    • Fluorescence in situ hybridization (FISH) test for ALK positivity using the Food and Drug Administration (FDA)-approved FISH test (Abbott Molecular Inc), using Vysis breakapart probes (defined as 15% or more positive tumor cells); OR
    • Harboring a confirmed ALK positivity, as determined by positivity to the Ventana immunohistochemistry (IHC) assay
  • Arms 1A: previously treated with and progressed on gemcitabine-containing therapy
  • Arms 1, 2, 3: patients should have clinically measurable or evaluable malignant disease
  • Arms 1A, 2A, 3A: patients with at least one measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 that have not been previously irradiated
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Life expectancy >= 3 months
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (system international [SI] units 1.5 x 10^9/L)
  • Platelets >= 100,000 cells/mm^3 (SI units 100 x 10^9/L)
  • Hemoglobin >= 9 g/dL (SI units 90 g/L) (in the absence of transfusion within 24 hours prior to dosing)
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =< 3 x upper limit of normal (ULN); in patients with known hepatic involvement, AST and ALT =< 5 x ULN are allowed
  • Total bilirubin =< 1.5 x ULN
  • Calculated or measured creatinine clearance (CrCL) >= 60 mL/min using modified Cockcroft and Gault formula
  • Serum lipase =< 2 x ULN
  • Serum amylase =< 2 x ULN
  • International normalized ratio (INR) =< 1.5; (anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at the first dose of study agent)
  • If urinalysis shows proteinuria, 24 hour urine collection is to be performed and the 24 hour urine protein is to be < 2 grams to be eligible
  • Willing and able to comply with scheduled visits, treatment plan and laboratory tests
  • Ability to understand and willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures
  • Patient must consent to the use of their archival tumor tissue for protocol use if available

Exclusion Criteria:

  • Arms 2, 2A, 3, 3A: patients who previously received > 2 lines of systemic chemotherapy for advanced or metastatic disease
  • Previous pelvic radiation affecting >= 25% of the bone marrow; patients who received whole pelvic radiation are excluded
  • Patients who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosourea, mitomycin-C, targeted therapy and radiation) =< 4 weeks prior to starting study drug, or who have not recovered from side effects of such therapy
  • Patients who have received the last administration of nitrosourea or mitomycin-C =< 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
  • Patients who have had radiotherapy =< 4 weeks prior to starting study drug, or =< 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g., for analgesic purpose or for lytic lesions at risk of fracture), or who have not recovered from radiotherapy toxicities
  • Patients who have received targeted therapy (e.g., sunitinib, sorafenib, pazopanib), except ALK inhibitors, =< 2 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
  • The patient is less than 5 half-lives from prior ALK inhibitor or targeted therapy (for adequate wash-out) without recovery from treatment toxicities to < grade 1 or to their pre-treatment levels
  • Patients with known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
  • Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury =< 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device =< 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
  • Known hypersensitivity or infusion reaction to cisplatin and gemcitabine
  • Patients with known hypersensitivity to any of the excipients of ceritinib (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
  • Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with ceritinib and for the duration of participation:
    • Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes
    • Strong inhibitors or strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/5
    • Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) and/or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9)
    • Therapeutic doses (defined as doses need to achieve target INR > 1.5) of warfarin sodium (Coumadin) or any other Coumadin-derived anti-coagulant; anticoagulants not derived from warfarin are allowed (e.g., dabigatran, rivaroxaban, apixaban)
    • Unstable or increasing doses of corticosteroids
    • Enzyme-inducing anticonvulsive agents
    • Herbal supplements
  • Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study; impaired cardiac function or clinically significant cardiac diseases, including any of the following:
    • Unstable angina within 6 months prior to screening
    • Myocardial infarction within 6 months prior to screening
    • History of documented congestive heart failure (New York Heart Association functional classification III - IV)
    • Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without antihypertensive medication
    • Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening
    • Ventricular arrhythmias; supraventricular and nodal arrhythmias not controlled with medication
    • Other cardiac arrhythmia not controlled with medication
    • Corrected QTc > 450 msec using Fridericia correction on the screening electrocardiogram (ECG)
  • Any active gastrointestinal (GI) impairment which, in the opinion of the investigator, would impair or alter the absorption of ceritinib (e.g., ulcerative colitis, or Crohn's disease)
  • Ongoing GI adverse events > grade 2 (e.g., nausea, vomiting, or diarrhea) at the start of the study
  • History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study compliance
  • Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
  • Pregnant or breast-feeding women
  • Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 3 days prior to starting study treatment
  • Women of child-bearing potential, who are biologically able to conceive, not employing 2 forms of highly effective contraception; male not using at least at least one form of highly effective contraception will be excluded; highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 8 weeks after the end of study treatment; oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study
  • Patients with untreated brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases; patients with brain metastases that have been definitively treated and on stable or decreasing dose of steroid within 4 weeks of starting study treatment will be eligible
Open or close this module Contacts/Locations
Study Officials: Wen Wee Ma
Principal Investigator
Roswell Park Cancer Institute
Locations: United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Contact:Contact: Roswell Park 877-275-7724 ASKRPCI@roswellpark.org
Contact:Principal Investigator: Wen W. Ma
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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