Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies

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Brief Title

Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies

Official Title

A Phase II, Multicenter, Single-Arm Study of Oral Ceritinib in Adult Patients With ALK and ROS1 Activated Gastrointestinal Malignancies

Brief Summary

      The available data indicate that Ceritinib has substantial anti-tumor activity in patients
      with anaplastic lymphoma kinase (ALK) and ROS1 rearranged non-small cell lung cancer (NSCLC).
      This trial will investigate the potential of Ceritinib in patients with advanced
      gastrointestinal malignancies with ALK and ROA1 rearrangement, and for whom there is no
      available therapeutic option.

Detailed Description

      This is a single-arm, open-label, multicenter, phase II study of ceritinib in adult patients
      with ALK- and ROS1 activated colorectal, cholangiocarcinoma, pancreatic, hepatic, gastric, or
      esophageal adenocarcinoma. An estimated 500 patients will be screened for ALK and ROS1 by
      fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) per institutional
      standard of care (SOC), and/or ALK/ROS1 by next-generation sequencing (NGS). At least 30
      identified patients will be treated with ceritinib per protocol. Treatment with ceritinib
      will continue until patient experiences unacceptable toxicity that precludes further
      treatment, discontinues treatment at the discretion of the investigator or patient, starts a
      new anticancer therapy and/or dies.

      Male and female patients aged 18 or over that have colorectal adenocarcinoma,
      cholangiocarcinoma, pancreatic, hepatocellular, gastric or esophageal adenocarcinoma that
      contain an activated ALK gene due to rearrangement, mutation, amplification, translocation or
      other mechanisms. Patients must have been pretreated with cytotoxic chemotherapy.

Study Phase

Phase 2

Study Type


Primary Outcome

Clinical Benefit Rate (CBR) of ceritinib, as defined as the percentage of patients who have achieved complete response, partial response, and stable disease at 2 months per RECIST 1.1) to ceritinib by investigator assessment

Secondary Outcome

 Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Colorectal Adenocarcinoma



Study Arms / Comparison Groups

Description:  Phase II, single-arm study of oral ceritinib in adult patients with ALK and ROS1 activated gastrointestinal malignancies


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

December 2015

Completion Date

March 29, 2018

Primary Completion Date

March 29, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Histologically or cytologically confirmed diagnosis of inoperable colorectal
             adenocarcinoma, pancreatic, hepatocellular, cholangiocarcinoma, small bowel, gastric
             or esophageal adenocarcinoma that carries an activated ALK or ROS1 pathway

          2. Age 18 years or older at the time of informed consent.

          3. Patients must have received at least 1 line of cytotoxic chemotherapy

          4. Patients must have archival tissue sample available, collected either at the time of
             diagnosis or any time since.

             - If archival tissue is unavailable, patient must be eligible and willing to undergo a
             fresh tissue biopsy

          5. Patients must have recovered from all toxicities related to prior anticancer therapies
             to grade ≤ 2 (CTCAE v 4.03) provided that concomitant medication is given prior to
             initiation of treatment with LDK378, except for patients with grade 2 nausea/vomiting
             and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to
             participate in the study. Additionally, patients with any grade of alopecia are
             allowed on treatment.

          6. Cohort Expansion Phase: Patient must have measurable lesions as defined by RECIST
             version 1.1 criteria.

          7. ECOG performance status 0-2

          8. Patients must have normal organ and marrow function as defined below: Bone marrow
             function defined as the following: An absolute neutrophil count ≥ (ANC) 1,500/mcl.
             Platelets ≥ 75,000/mcl. Hemoglobin ≥ 8 g/dl.

          9. Renal function defined as the following: Serum creatinine less than or equal to 1.5 x
             institutional upper limit normal (ULN). Calculated or measured creatinine clearance
             (CrCL) ≥ 30 mL/min

         10. Hepatic function defined as the following: Serum total bilirubin < 1.5 x ULN. AST
             (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 3.0 x ULN. Serum albumin ≥ 2.5 g/dl. If
             liver involvement, AST, ALT, and alkaline phosphatase ≤ 5.0 x ULN.

         11. Serum amylase ≤ 2 x ULN and serum lipase ≤ 1 x ULN

         12. Fasting plasma glucose ≤175 mg/dL (≤9.8 mmol/L)

         13. Patient must have the following laboratory values or have the following laboratory
             values corrected with supplements to be within normal limits at screening:

               -  Potassium ≥ lower limit of normal (LLN)

               -  Magnesium ≥ LLN

               -  Phosphorus ≥ LLN

               -  Total calcium (corrected for serum albumin) ≥ LLN

         14. A male subject of fathering potential must use an adequate method of contraception to
             avoid conception throughout the study [and for up to 12 weeks after the last dose of
             study drug] to minimize the risk of pregnancy. If the partner is pregnant or
             breastfeeding, the subject must use a condom. A condom is required to be used also by
             vasectomized men in order to prevent delivery of the drug via seminal fluid.

         15. Women of childbearing potential (WOCBP) must be using an adequate method of
             contraception to avoid pregnancy throughout the study and for up to 12 weeks after the
             last dose of study drug to minimize the risk of pregnancy. WOCBP must have a negative
             serum or urine pregnancy test within 72 hours before the start of the investigational
             product. Highly effective contraception methods include:

               -  Total abstinence (when this is in line with the preferred and usual lifestyle of
                  the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal,
                  post-ovulation methods) and withdrawal are not acceptable methods of

               -  Female sterilization (have had surgical bilateral oophorectomy with or without
                  hysterectomy) or tubal ligation at least six weeks before taking study treatment.
                  In case of oophorectomy alone, only when the reproductive status of the woman has
                  been confirmed by follow up hormone level assessment.

               -  Male sterilization (at least 6 months prior to screening) with the appropriate
                  post-vasectomy documentation of the absence of sperm in the ejaculate. For female
                  subjects on the study the vasectomized male partner should be the sole partner
                  for that subject.

               -  Combination of any two of the following (a+b or a+c or b+c):

               -  Use of oral, injected or implanted hormonal methods of contraception or other
                  forms of hormonal contraception that have comparable efficacy (failure rate <
                  1%), for example hormone vaginal ring or transdermal hormone contraception.

               -  Placement of an intrauterine device (IUD) or intrauterine system (IUS).

             Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault
             caps) with spermicidal foam/gel/film/cream/vaginal suppository.

             In case of use of oral contraception, women should have been stable on the same pill
             for a minimum of 3 months before taking study treatment.

             Women are considered post-menopausal and not of child bearing potential if they have
             had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile
             (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral
             oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior
             to screening. In the case of oophorectomy alone, only when the reproductive status of
             the woman has been confirmed by follow up hormone level assessment is she considered
             not of child bearing potential.

         16. Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          1. Patients who have had chemotherapy or radiotherapy within 3 weeks (4 weeks for
             radiotherapy to the lung fields and 6 weeks for nitrosoureas or mitomycin C) prior to
             entering the study or those who have not recovered from adverse events due to agents
             administered more than 4 weeks earlier.

          2. Patients with known hypersensitivity to any of the excipients of ceritinib
             (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and
             magnesium stearate)

          3. Prior therapy with ceritinib or other ALK or ROS1 inhibitor agents

          4. Patients who are currently receiving treatment with warfarin sodium (Coumadin®) or any
             other coumarin-derivative anti-coagulants.

          5. Patients with symptomatic CNS metastases who are neurologically unstable or have
             required increasing doses of steroids within the 1 week prior to study entry to manage
             CNS symptoms.

          6. Impairment of GI function or GI disease that may significantly alter the absorption of

          7. History of pancreatitis or history of increased amylase or lipase that was due to
             pancreatic disease.

          8. 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).

          9. Cardiac conditions as follows:

               -  Active coronary artery disease, unstable or newly diagnosed angina or myocardial
                  infarction less than 6 months prior to first study drug administration.

               -  Class II-IV New York Heart Association (NYHA) congestive heart failure.

               -  Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or

               -  QTc (Frederica) prolongation > 470 msec.

               -  Subjects with valvular heart disease CTCAE (Version 4.0) Grade 2.

               -  Known left ventricular ejection fraction (LVEF) < 50%.

               -  Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mm Hg
                  and/or Diastolic Blood Pressure (DBP) ≥ 100 mm Hg, with or without
                  anti-hypertensive medication

         10. 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 LDK378 and for the
             duration of participation:

               -  Medication with a known risk of prolonging the QT interval or inducing Torsades
                  de Pointes (please refer to

               -  Strong inhibitors or strong inducers of CYP3A4/5 (please refer to

               -  Medications with a low therapeutic index that are primarily metabolized by
                  CYP3A4/5, and/or CYP2C9 (please refer to

               -  Therapeutic doses of warfarin sodium (Coumadin) or any other coumarin-derived
                  anti-coagulant. Anti-coagulants not derived from warfarin are allowed (e.g.,
                  dabigatran, rivaroxaban, apixaban).

               -  Unstable or increasing doses of corticosteroids

               -  Enzyme-inducing anti-convulsive agents

               -  Herbal supplements

         11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris (Canadian
             Cardiovascular Society grade II-IV despite medical therapy), cardiac arrhythmia,
             active bleeding diatheses, or psychiatric illness/social situations that would limit
             compliance with study requirements.

         12. Major surgical procedure, open biopsy, or significant traumatic injury less than 4
             weeks or those who receive minor surgical procedures (e.g. core biopsy or fine needle
             aspiration) within 1 week from first dose of first study drug administration.

         13. Known inability to swallow up to five LDK378 capsules daily.

         14. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive hCG laboratory test.




18 Years - N/A

Accepts Healthy Volunteers



Christopher Lieu, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Criterium, Inc.


 University of Colorado, Denver

Study Sponsor

Christopher Lieu, MD, Principal Investigator, Criterium Inc., d.b.a. Academic GI Cancer Consortium (AGICC)

Verification Date

March 2018