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Glioblastoma MultiformePhase 1/2NCT00650949

Efficacy Study of CYT997 in Combination With Carboplatin in Glioblastoma

A Phase 1/2 study testing CYT997 and Carboplatin in people with Glioblastoma Multiforme, run by Gilead Sciences at 4 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study seeks to (i) determine the safe dose of CYT997 when given in combination with carboplatin in patients with relapsed glioblastoma multiforme (glioma) and (ii) to determine whether the combination of CYT997 with carboplatin is a useful treatment for glioma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma Multiforme
What is being tested?
CYT997 and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesAustralia
Study dates
Nov 2009to Jun 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 echocardiogram
  • Must agree to use adequate contraceptive measures if indicated
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • 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 requirements.
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  • 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.

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Monash Medical Centre

    Melbourne, Victoria, 3168

  • Gold Coast Hospital

    Southport, Queensland, 4215

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

About this study

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

This study seeks to (i) determine the safe dose of CYT997 when given in combination with carboplatin in patients with relapsed glioblastoma multiforme (glioma) and (ii) to determine whether the combination of CYT997 with carboplatin is a useful treatment for glioma.

Being tested
CYT997, Carboplatin
Keywords
Glioblastoma multiforme, Glioma, Phase Ib/II, CYT997
Medical subject headings
Glioblastoma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CYT997Drug

    Escalating doses (100mg/m^2 to 150mg/m^2), 24-hour intravenous infusion on Day 2 of a 21-day cycle (Phase Ib component). Dose selected in Phase Ib component to be used for Phase II component.

  • CarboplatinDrug

    Intravenous infusion over 1 hour at area under the concentration-time curve (AUC)=5 on Day 1 of a 21-day cycle

Study groups in NCT00650949
Study groupRoleWhat they receive
CYT997ExperimentalNot described
Receives: Drug: CYT997; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

  2. Progression-free survival at 6 months (PFS-6) utilising the dose of CYT997 identified in the Phase Ib component of this study (Phase II component)

    Measured: 6 months after initiation of therapy

Secondary outcomes (5)

  1. Objective response rate (ORR)

    Measured: Response is measured every second cycle of therapy

  2. Overall survival

    Measured: Baseline to study completion

  3. Safety and tolerability

    Measured: Measured continuously from study commencement through to 30 days after last dose of CYT997

  4. Effects on pharmacodynamic markers of vascular disruption and tumour apoptosis

    Measured: Measured during first cycle of therapy

  5. Pharmacokinetic analysis of carboplatin and CYT997 in combination

    Measured: Assessed during first cycle of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2008 (estimated)
  2. Study startNov 2009
  3. Primary completionJun 2011
  4. Study completionJun 2011

Why it stopped: Strategic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00650949
Sponsor's protocol ID
CCL08001
Status last verified
Apr 2013
First submitted
27 Mar 2008
Last updated
3 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CYT997 and Carboplatin in people with Glioblastoma Multiforme, run by Gilead Sciences at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of escalating doses of CYT997 when given in combination with standard carboplatin therapy (Phase Ib component) (time frame: Ongoing throughout therapy up until 30 days after last dose of CYT997). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00650949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.

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