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A Phase Ib/II Study of CYT997 in Combination With Carboplatin in Relapsed Glioblastoma Multiforme

Phase 1/Phase 2
18 Years
Not Enrolling
Glioblastoma Multiforme

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Trial Information

A Phase Ib/II Study of CYT997 in Combination With Carboplatin in Relapsed Glioblastoma Multiforme

Inclusion Criteria:

- Patients must have histologically-confirmed glioblastoma multiforme that has
progressed after initial surgery, radiation therapy and temozolomide chemotherapy.

- Measurable tumour must be present on gadolinium-enhanced MRI

- At least 3 months must have elapsed from completing radiation to minimize the
possibility of pseudo-progression.

- At least 4 weeks since prior chemotherapy (6 weeks if the last regimen included
bischloroethylnitrosourea (BCNU) or Chloroethyl-Cyclohexyl-NitrosoUrea (CCNU)).

- Age ≥ 18 years.

- If patients are taking steroids, the dose must be stable for = 7 days.

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

- Life expectancy of greater than 2 months.

- Patients must have adequate organ and marrow function as defined below:

- Absolute neutrophil count = 1.5 × 109/L

- Platelet count = 100 × 109/L

- Total bilirubin within normal limits

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 5 × upper
limit of normal (ULN)

- Creatinine within normal limits OR creatinine clearance = 60 mL/min/1.73 m2 for
patients with creatinine levels above normal

- Normal left ventricular ejection fraction on a gated blood pool scan or

- Must agree to use adequate contraceptive measures if indicated

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

Exclusion Criteria:

- Patients who have received any other investigational agent in the preceding four
weeks prior to commencing therapy in this study.

- Patients who have been previously treated with carboplatin.

- Patients who have been previously treated with bevacizumab or other anti-angiogenesis
or vascular-disrupting agents

- Patients who are receiving enzyme-inducing anticonvulsant drugs (EIACD) such as
phenytoin or carbamazepine.

- Patients with a history of allergic reactions attributed to compounds of similar
chemical composition to CYT997 or other agents used in the study.

- Patients with uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia
or psychiatric illness/social situations that would limit compliance with study

- Pregnant or lactating women.

- Patients with immune deficiency, including HIV-positive patients.

- Patients with uncontrolled diarrhoea despite optimal medication and those with any
history of acute gastrointestinal bleeding.

- Patients who are unable or unwilling to undergo MRI scanning

- Patients with the following conditions/treatments will be excluded:

- Myocardial infarction (MI) or stroke within 6 months

- History of stroke or transient ischemic attacks (TIAs)

- Unstable angina pectoris or acute ischemic changes on ECG

- History of diabetic retinopathy

- Symptomatic peripheral arterial disease o Major surgery in the last 4 weeks

- Evidence of intra-tumoural haemorrhage on imaging, except for stable grade-1
post-operative haemorrhage.

- Current therapeutic anti-coagulation with warfarin or a heparin (excludes
lowdose prophylactic heparin).

- Uncontrolled hypertension

- The need for any anti-arrhythmic drugs

- Presence of luminal stenosis of 50% or more in any of the extracranial or
intracranial arteries supplying the brain, as measured by magnetic resonance
angiography (MRA) at baseline.

- Patients with a baseline prolongation of the QTc interval of Common Terminology
Criteria (CTC) grade 1 (QTc > 0.45- 0.47 sec) or greater.

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

- Left ventricular ejection fraction (LVEF) < 45% as determined by multigated
acquisition (MUGA) scan or echocardiogram;

- complete left bundle branch block;

- obligate use of a cardiac pacemaker;

- congenital long QT syndrome;

- history or presence of ventricular tachyarrhythmia;

- presence of unstable atrial fibrillation (ventricular response > 100 bpm)
Patients with stable atrial fibrillation are eligible, provided they do not meet
any of the other cardiac exclusion criteria;

- clinically significant resting bradycardia (< 50 bpm);

- right bundle branch block + left anterior hemiblock (bifascicular block);

- angina pectoris = 3 months prior to starting study drug;

- acute MI = 3 months prior to starting study drug; or

- other clinically significant heart disease (e.g., congestive heart failure
(CHF), uncontrolled hypertension, history of labile hypertension, or history of
poor compliance with an antihypertensive regimen).

- Patients currently receiving treatment with medications known to prolong the QTc
interval and/or to induce Torsades de Pointes arrhythmia.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of escalating doses of CYT997 when given in combination with standard carboplatin therapy (Phase Ib component)

Outcome Time Frame:

Ongoing throughout therapy up until 30 days after last dose of CYT997

Safety Issue:


Principal Investigator

Jason Lickliter, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Frankston Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

June 2011

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma multiforme
  • Glioma
  • Phase Ib/II
  • CYT997
  • Glioblastoma