Clinical Trial Details
Braintumor Website

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NCT02933736 : Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients
PhaseEarly Phase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria

- One prior resection of histologically-diagnosed WHO Grade III or IV glioma, or WHO
grade II or III meningioma.

- MRI evidence of disease recurrence

- For gliomas, archival tissue much demonstrate (a) RB positivity on
immunohistochemistry OR no RB mutations on next-gen sequencing (NGS), (b) Chromosome
9p21.3 deletion on FISH OR CDKN2A/B/C loss on array CGH.

- For meningiomas, archival tissue much demonstrate (a) RB positivity on
immunohistochemistry OR no RB mutations on next-gen sequencing (NGS).

- Eastern Cooperative Oncology Group (ECOG) performance status =2

- Patients = 18 years of age

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

- Patient has voluntarily agreed to participate by giving written informed consent.

(Written informed consent for the protocol must be obtained prior to any screening
procedures. If consent cannot be expressed in writing, it must be formally documented and
witnessed, ideally via an independent trusted witness.)

- Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests and other procedures.

- 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 ribociclib. Exception to this criterion: patients with
any grade of alopecia are allowed to enter the treatment.

- The following laboratory criteria have been met:

- Absolute neutrophil count (ANC) =1.5 x 109/L

- Hemoglobin (Hgb) = 9 g/dL

- Platelets =100 x 109/L

- Potassium, total calcium (corrected for serum albumin), magnesium, and sodium
within normal limits for the institution or corrected to within normal limits
with supplements before first dose of study medication.

- INR =1.5

- Serum creatinine < 1.5 mg/dL or creatinine clearance > 50 mL/min

- In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) < 2.5 x ULN. If the patient has liver metastases, ALT and
AST < 5 x ULN

- Serum total bilirubin < ULN, or < 3.0 x ULN in patients with well-documented Gilbert's
syndrome.Patient with available standard 12-lead ECG with the following parameters at
screening (defined as the mean of the triplicate ECGs):

- QTcF interval at screening < 450 msec (using Fridericia's correction)

- Resting heartrate 50-90 bpm

- Must be able to swallow ribociclib capsules/tablets

Exclusion Criteria:

- Archival tissue not available for research use.

- Archival tumor not Rb-positive status

- No prior radiotherapy

- Co-morbid condition(s) that, at the opinion of the investigator, prevent safe surgical

- Active infection or fever > 38.5°C

- Patients with known hypersensitivity to any of the excipients of ribociclib

- Prior therapy with ribociclib.

- Patient has a concurrent malignancy or malignancy within 3 years prior to starting
study drug, with the exception of adequately treated, basal or squamous cell
carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled
nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).

- History of HIV infection.

- Other concurrent severe and/or uncontrolled medical condition that would, in the
investigator's judgment, cause unacceptable safety risks, contraindicate patient
participation in the clinical study or compromise compliance with the protocol.

- Clinically significant, uncontrolled heart disease and/or cardiac repolarization

- Currently receiving any of the following medications and cannot be discontinued 7 days
prior to starting study drug:

- Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit
hybrids, pummelos, star-fruit, and Seville oranges

- That have a narrow therapeutic window and are predominantly metabolized through

- Herbal preparations/medications, dietary supplements.

- Currently receiving or has received systemic corticosteroids =2 weeks prior to
starting study drug, or who have not fully recovered from side effects of such
treatment. (The following uses of corticosteroids are permitted: single doses, topical
applications, inhaled sprays, eye drops or local injections

- Currently receiving warfarin or other coumarin-derived anticoagulant for treatment,
prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or
fondaparinux is allowed.

- Participation in a prior investigational study within 30 days prior to enrollment or
within 5 half-lives of the investigational product, whichever is longer.

- Major surgery within 14 days prior to starting study drug or has not recovered from
major side effects.

- Has not recovered from all toxicities related to prior anticancer therapies to
NCI-CTCAE version 4.03 Grade <1 (Exception: alopecia).

- Child-Pugh score B or C.

- History of non-compliance to medical regimen or inability to grant consent.

- 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.]

- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of contraception
during dosing and for 3 months after the last dose of study treatment. 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.

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

- 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.

- Note: Oral contraceptives are allowed but should be used in conjunction with a
barrier method of contraception due to unknown effect of drug-drug interaction.

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 ago. 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.

- Sexually active males unless they use a condom during intercourse while taking drug and
for 21 days after stopping treatment and should not father a child in this period. A condom
is required to be used also by vasectomized men in order to prevent delivery of the drug
via seminal fluid.
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