Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01972750 : Dovitinib (TKI258) in the Treatment of Patients With Relapsed Glioblastoma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Subjects, male or female, Age ? 18 years

- First or second recurrence of histologically confirmed glioblastoma

- A Performance Scale of Karnofsky > 60%, ECOG ? 2 or WHO < 2

- Patients must have been on no steroids or a stable dose of steroids for at least 5
days before the baseline MRI scan

- Prior treatment with radiotherapy and temozolomide and a maximum of two prior
chemotherapies is permitted

- Chemotherapy must have been completed at least 4 weeks prior to study inclusion if
prior temozolomide and 6 weeks if prior nitrosoureas or mitomycin c.

- No radiotherapy within the 4 weeks prior to the diagnosis of progres-sion.

- Treatment with investigational drugs must have been completed at least 30 days prior
to study inclusion if prior small molecules and at least 30 days if prior antibodies
(e.g. bevacizumab)

- Patient may have been operated for recurrence. If operated residual and measurable
disease after surgery is not required but surgery must have confirmed the recurrence
a post-surgery. MRI should be available within 48 hours following surgery

- Surgery completed at least 2 weeks before study inclusion and pa-tients should have
fully recovered

- Craniotomy or intracranial biopsy site must be adequately healed free of drainage or
cellulitis, and the underlying cranioplasty must appear intact at the time of study
inclusion.

- Adequate organ function as described below:

- Adequate bone marrow reserve: ANC ? 1.5 x 10^9/L, Platelets ? 100 x 10^9/L,
Haemoglobin > 9 g/dL

- Adequate liver function: Total bilirubin ? 1.5 x ULN (excepted for patients with
Gilbert's syndrome), ALT and AST ? 3.0 x ULN

- Adequate renal function: Creatinine ? 1.5 x ULN

- For non operated patients recurrent disease must be at least one bi-dimensionally
measurable contrast-enhancing lesion with clearly de-fined margins by MRI scan, with
minimal diameters of 10 mm, visible on 2 or more axial slices 5 mm apart, based on
MRI scan done within two weeks prior to study inclusion.

- Patients who require anti-convulsant therapy must be taking non-enzyme inducing
antiepileptic drugs (non-EIAED). Patients previously on EIAED must be switched to
non-EIAED and stable at least 2 weeks prior to study inclusion and be stable on a
constant dose.

- No non tumor related surgery or other invasive procedures (major sur-gical procedure,
open biopsy or significant traumatic injury) within 4 weeks prior to study inclusion,
or anticipation of the need for major surgery during the course of the study
treatment.

- No core biopsy or other minor surgical procedure within 7 days prior to
randomization. Placement of a central vascular access device (CVAD) if performed at
least 5 days prior to study treatment administration is allowed.

- Before patient study inclusion and study related procedures (that would not have been
performed as part as standard care), written in-formed consent must be given
according to ICH/GCP, and nation-al/local regulations.

- Subjects with the ability to follow study instructions and likely to attend and
complete all required visits

Exclusion Criteria:

General Exclusion Criteria:

- Subjects not able to give consent

- Subject without legal capacity who is unable to understand the nature, scope,
significance and consequences of this clinical trial

- Known history of hypersensitivity to the investigational drug or to drugs with a
similar chemical structure

- Simultaneously participation in another clinical trial or participation in any
clinical trial involving administration of an investigational medicinal product
within 30 days prior to clinical trial beginning

- Subjects with a physical or psychiatric condition which at the investigator's
discretion may put the subject at risk, may confound the trial results, or may
interfere with the subject's participation in this clinical trial

- Known or persistent abuse of medication, drugs or alcohol

Indication specific exclusion criteria:

- Evidence of current/active intratumor hemorrhage by MRI

- More than two relapses

- Elongation of corrected QT-time (QTc) > 450 ms (male patients) and ? 460 ms (female
patients), respectively

- Patients with any clinically significant medical or surgical condition which,
according to investigators´ discretion, should preclude participation - i.e. severe
renal disease, severe pancreatic disease, active or uncontrolled infection,
uncontrolled diabetes, active or chronic liver disease (cirrhosis, chronic active
hepatitis or chronic persistent hepatitis) - hepatitis B or C virus carriers with
normal liver function tests, can be included.

- Patients with impaired cardiac function or clinically significant cardiac diseases,
including any of the following:

- History or presence of serious uncontrolled ventricular arrhythmi-as

- Bradycardia (<60/min): i) Clinically significant resting bradycardia (=> 40/min)
with syncopes or chronotropic incompetence or ii) asymptomatic bradycardia with
a heart rate < 40/min and/or paus-es in ventricular rate > 3 s

- LVEF assessed by 2-D echocardiogram (ECHO) < 50% or lower limit of normal (which
ever is higher)

- Any of the following within 6 months prior to starting TKI258:

- Myocardial infarction (MI),

- severe/unstable angina,

- Coronary Artery Bypass Graft (CABG),

- Congestive Heart Failure (CHF),

- Cerebrovascular Accident (CVA),

- Transient Ischemic Attack (TIA)

- Uncontrolled hypertension defined by a SBP ? 160 mm Hg and/or DBP ? 100 mm Hg, with
or without anti-hypertensive medication. Initiation or adjustment of antihypertensive
medication(s) is allowed prior to starting Dovitinib (TKI258)

- Patients with impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of TKI258 (e.g. severe ulcer-ative diseases,
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or extensive (>1m)
small bowel resection, inability to swal-low oral medications). Prior partial
gastrectomy is not an exclusion cri-terion.

- Patients with prior complete gastrectomy

- Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count ?1.5 x
109 /L or platelet count ? 100 x 109 /L or re-quiring regular blood transfusions to
maintain haemoglobin > 9g/dL

- Serum bilirubin ? 1.5 x ULRR (except for patients with known docu-mented cases of
Gilbert's Syndrome)

- ALT or AST ? 2.5 x ULRR.

- Serum creatinine > 1.5 x ULRR or a creatinine clearance of ? 50 mL/min calculated by
Cockcroft-Gault

- Unresolved toxicity > CTCAE grade 1 from previous anti-cancer thera-py (including
radiotherapy) except alopecia (if applicable)

- Patients with another primary malignancy within 3 years prior to start-ing the study
drug, with the exception of adequately treated in-situ car-cinoma of the uterine
cervix, or completely excised (R0 resection) ba-sal or squamous cell carcinoma of the
skin

- Known diagnosis of human immunodeficiency virus (HIV) infection. HIV testing is not
mandatory

- Other concomitant anti-cancer therapy except steroids

- Patients who are currently receiving anticoagulation treatment with therapeutic doses
of warfarin or equivalent anticoagulants (e.g., coumadin, rivaroxaban, apixaban,
dabigatran) or receive antiplatelet agents (e.g., high dose aspirin or clopidogrel or
other) or have an INR >1.5. Treatment with acetylsalicyclic acid 100 mg daily or
prophylactic use of low molecular weight heparin (LMWH) is allowed.

- Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or
intrapelvic) ? 4 weeks prior to starting TKI258 or who have not recovered from the
adverse effects of such therapy

- Patients with a history of pulmonary embolism (PE), or untreated deep venous
thrombosis (DVT) within the past 6 months

- Inability to undergo MRI

- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up scheduled visits (at the
discretion of the investigator)

Exclusion criteria regarding special restrictions for females:

- Current or planned pregnancy or nursing women

- Positive pregnancy test (blood-test) prior to receiving IMP

- Females of childbearing potential, who are not using and not willing to use medically
highly reliable methods of contraception for the entire study duration (such as
injectable, or implantable contraceptives, or intrauterine contraceptive devices)
unless they are surgically sterilized / hysterectomized or there are any other
criteria considered sufficiently reliable by the investigator in individual cases

- Males, who are not using and/or not willing to use an effective form of barrier
conception for the entire study duration (such as male con-doms) unless they are
surgically vasectomised or there are any other criteria considered sufficiently
reliable by the investigator in individual cases.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01972750      |      Link to official Clinicaltrials.gov listing
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