Clinical trial NCT02914327 (phase 1, status: withdrawn)
Conditions: cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: snx-5422 plus ibrutinib
SMILES: NC1=NC=NC2=C1C(=NN2[C@@H]1CCCN(C1)C(=O)C=C)C1=CC=C(OC2=CC=CC=C2)C=C1
Reason stopped: 
    lack of enrollment
  
Eligibility criteria:

        Inclusion Criteria:

          -  Males or non-pregnant, non-breastfeeding females 18 years-of-age or older

          -  A diagnosis of CLL as defined by IWCLL 2008 criteria and currently on treatment with
             ibrutinib without evidence of disease progression.

          -  No more than 4 prior lines of anti leukemia therapy (not including ibrutinib)

          -  Presence of mutated BTK in ≥ 4% of peripheral blood or bone marrow CLL cells, or ≥1%
             and rising on two separate measurements obtained at least 28 days apart.

          -  Life expectancy of at least 9 months

          -  Karnofsky performance score 70

          -  Adequate baseline laboratory assessments

          -  Signed informed consent form

          -  Recovered from toxicities of previous anticancer therapy to CTCAE Grade ≤ 1 with the
             exception of alopecia

          -  Subjects with reproductive capability must agree to practice adequate contraception
             methods.

        Exclusion Criteria:

          -  Subjects experiencing toxicity with ibrutinib

          -  Prior treatment with any Hsp90 inhibitor.

          -  Major surgery or significant traumatic injury within 4 weeks of starting study
             treatment.

          -  Conventional chemotherapy or radiation within 4 weeks.

          -  The need for treatment with medications with clinically-relevant metabolism by the
             cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of
             SNX-5422

          -  Screening ECG QTc interval 470 msec for females, 450 msec for males.

          -  At increased risk for developing prolonged QT interval unless corrected to within
             normal limits prior to first dose of SNX-5422

          -  Patients with chronic diarrhea or with Grade 2 or greater diarrhea despite appropriate
             medical management.

          -  Gastrointestinal diseases or conditions that could affect drug absorption

          -  Gastrointestinal diseases that could alter the assessment of safety, including
             irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic
             coloproctitis.

          -  History of documented adrenal dysfunction not due to malignancy.

          -  History of chronic liver disease.

          -  Active hepatitis A or B.

          -  Current alcohol dependence or drug abuse.

          -  Use of an investigational treatment (except for ibrutinib) from 30 days prior to the
             first dose

          -  Glaucoma, retinitis pigmentosa, macular degeneration, or any retinal changes detected
             by ophthalmological examination that are considered clinically important by examiner.

          -  Psychological or social reasons that would hinder or prevent compliance with the
             requirements of the protocol or compromise the informed consent process.