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TumorsPhase 1NCT00338026

A Phase I Study of ECO-4601 in Patients With Advanced Cancer

A Phase 1 study testing ECO-4601 in people with Tumors and Glioma, run by Thallion Pharmaceuticals at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to determine the maximum tolerated dose (MTD) and the recommended dose for future studies of ECO-4601 administered as a continuous IV infusion for 14 days with 7 days recovery (21 day cycle) in patients with histologically confirmed solid tumors (high grade glioma, colorectal, lung… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumors, Glioma, Colorectal Cancer
What is being tested?
ECO-4601
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesCanada
Study dates
Feb 2006to Aug 2007
Phase
Phase 1
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

  • Informed about the study and consent to participate in the study
  • Clinically or radiologically documented advanced solid malignancy for which no standard therapy is available, or which has failed standard therapy
  • Patients with the following solid tumors: high grade glioma, colorectal, prostate, pancreatic, lung, ovarian and breast carcinoma
  • Age ≥ 18 years of age
  • ECOG ≤ 2
  • Laboratory hematology and biochemistry protocol test result abnormalities ≤ Grade 1, graded using NCI CTCAE version 3.0
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  • Patients with no chemotherapy during the 4 weeks preceding patients' first dose of ECO-4601 (day 1, cycle 1)
  • No other anticancer treatment during the study
  • Patients can be receiving stable or decreasing dose of steroids within 2 weeks prior to patient's signature of the informed consent
  • Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre
  • Previous Therapy
  • Hormonal therapy: Patients may have had prior hormonal therapy provided it is discontinued upon ICF signature
  • Radiation: Patients may have had prior radiation therapy. Patients must have recovered from the acute toxic effects of radiotherapy
  • Previous surgery: Previous surgery is permitted provided that at least 2 weeks have elapsed between major surgery (non-biopsy) and ICF signature

Who cannot join

  • Patients with brain metastases
  • Unlikely to comply with protocol or difficulty to understand the purpose of the study
  • Life expectancy < 12 weeks
  • Clinically significant co-morbid disease, e.g. renal failure, ischemic vascular disease, uncontrolled seizure, dementia
  • Any patient with a potentially curable malignancy who has not yet received appropriate standard therapies
  • Anti seizure drugs known inducers of cytochrome P450
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  • Documented HIV, active hepatitis B or C infections
  • Patients with active or uncontrolled infections or with serious illnesses or medical conditions, which would not permit the patient to be managed according to protocol
  • Pregnant or lactating women; both men and women enrolled on study should be using adequate birth control measures throughout the course of the study. Women of childbearing potential must have a negative serum or urine pregnancy test documented within 14 days prior to registration and at study start
  • Inability or refusal to practice contraception during therapy of ECO-4601, unless patient is surgically sterile or woman is postmenopausal for at least 2 years
  • Patients who have been treated with any investigational drug within 4 weeks of patient's signature of informed consent form, or who are receiving concurrent treatment with other experimental drugs or anti cancer therapy
  • Patients in whom a proper central line cannot be established
  • Concomitant therapy with therapeutic coumadin; patients can be transferred to low molecular weight heparin
  • Patients on low molecular weight heparin for < 2 weeks prior to ICF signature
  • Polysorbate 80 being a major constituent of ECO-4601 and known to cause hypotension, patients with uncontrolled hypotension will be excluded
  • Known hypersensitivity to farnesylated dibenzodiazepinone or any of the formulation components
  • Concomitant Therapy Permitted:
  • Patients may receive ongoing supportive and palliative care (eg: pain control) as clinically indicated throughout the study.
  • Patients can be treated with corticosteroids if medically needed
  • Usage of low molecular weight heparin is allowed
  • Anti seizure products are permitted provided they are not inducers of cytochrome P450.
  • Concomitant Therapy Not Permitted:
  • Other anticancer treatment
  • Other investigational therapy
  • Concomitant therapy with coumadin
  • Cytochrome enzyme inducing anti epileptics
  • G-CSF, GM-CSF and other growth factors may not be used as a substitute for a scheduled dose reduction; however they may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated at the discretion of the investigator. Use of erythropoietin is allowed if treatment has been initiated for ≥ 2 months. Use of growth factors must be documented on case report forms.
  • Hormonal therapy

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Hôpital Charles LeMoyne

    Greenfield Park, Quebec, J4V 2H1

  • Sir Mortimer B. Davis Jewish General Hospital

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

Official title: A Phase I, Dose Finding, Pharmacokinetic, and Safety Study of Continuous IV Infusion of ECO-4601 in Patients With Advanced Cancer Including an Extension Portion to Obtain Safety Data at the Highest Tolerable Dose

The purpose of this study was to determine the maximum tolerated dose (MTD) and the recommended dose for future studies of ECO-4601 administered as a continuous IV infusion for 14 days with 7 days recovery (21 day cycle) in patients with histologically confirmed solid tumors (high grade glioma, colorectal, lung, breast, ovarian, pancreatic and prostate). This study was also designed to determine the clinical pharmacokinetic profile, safety of multiple cycles of administration, and document the antitumor activity of ECO-4601.

Being tested
ECO-4601
Keywords
Solid Tumors, Thallion, TLN-4601, Ecopia, ECO-4601, Patients with histologically confirmed solid tumors:, High Grade Glioma, Colorectal, Lung, Breast, Ovarian, Pancreatic, Prostate
Medical subject headings
Neoplasms, Glioma, Colorectal Neoplasms, Lung Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms

What participants receive

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

  • ECO-4601Drug

    Also called TLN-4601

    Continuous IV infusion for 14 days with 7 days recovery (21 day cycle)

Study groups in NCT00338026
Study groupRoleWhat they receive
ECO-4601ExperimentalNot described
Receives: Drug: ECO-4601

What is being measured

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

  1. Safety/tolerability of ECO-4601

  2. Determination of MTD of ECO-4601

  3. Determination of recommended dose for future studies of ECO-4601

Secondary outcomes (3)

  1. Pharmacokinetics of ECO-4601

  2. Safety of multiple cycles of administration of ECO-4601

  3. Documentation of ECO-4601 antitumor activity as per RECIST criteria

Timeline

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

  1. First posted20 Jun 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionAug 2007
  4. Study completionAug 2007

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00338026
Sponsor's protocol ID
ECO-4601-101
Status last verified
Jul 2008
First submitted
15 Jun 2006
Last updated
15 Jul 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ECO-4601 in people with Tumors and Glioma, run by Thallion Pharmaceuticals at 2 sites in Canada.

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 14 inclusion and 28 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: finished, as of the sponsor's last update on 15 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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/tolerability of ECO-4601. The study lists 3 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 NCT00338026.

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 15 Jul 2008.

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