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AzTrials

NeoplasmsPhase 1NCT00487786

Safety Study of an Antisense Product in Prostate, Ovarian, NSCL, Breast or Bladder Cancer

A Phase 1 study testing OGX-427 and Docetaxel in people with Neoplasms, run by Achieve Life Sciences at 3 sites in 2 countries.

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

This study is for patients with cancer who have failed potentially curative treatments or for whose disease a curative treatment does not exist. OGX-427 is an antisense product that inhibits expression of one of the heat shock proteins. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
OGX-427 and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
3 sitesin 2 countries
Study dates
Jun 2007to Oct 2011
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

  • Age ≥ 18 years at time of consent.
  • Histologically or cytologically confirmed diagnosis of one of the following: adenocarcinoma of the breast, ovary, or prostate, any NSCLC or bladder cancer.
  • Must have metastatic disease. Prostate cancer patients must be hormone refractory.
  • Must have failed therapies that are potentially curative; failed/refused standard therapy known to prolong survival or progression-free survival; or failed/refused therapy, that in the view of the investigator, would be beneficial in improvement of symptoms
  • Patients enrolled into Cohorts 6 and 7 (OGX 427 in combination with docetaxel) must have disease that has a possibility of responding to docetaxel.
  • A minimum of 28 days must have elapsed between any major surgery, the last dose of chemotherapy, radiotherapy (except limited fields-see #7 below), radioisotope, immunotherapy or experimental agent and enrollment onto the study. Note: Patients on hormone or estrogen therapy and steroids for treatment of their disease may remain on therapy.
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  • A minimum of 7 days must have elapsed between a single fraction of ≤ 800 cGy to a limited field or conventional radiotherapy to a limited non marrow-bearing field such as an extremity or orbit and enrollment onto the study.
  • Recovery from all toxicities of prior therapy including chemotherapy, radiation therapy, immunotherapy and experimental agents to ≤ grade 2 by NCI CTCAE, version 3.0.
  • If not treated with bilateral orchiectomy, patients with HRPC must be willing to continue luteinizing hormone releasing hormone (LHRH) analogues throughout the study.
  • If taking opioid medication, patient must be willing to continue on the same opioid medication that they are on at enrollment through the PK/ECG evaluations during Cycle 1.
  • Karnofsky score of ≥60%.
  • Various laboratory requirements.
  • Must be willing to use effective contraception during and for 3 months following treatment if of child bearing potential.
  • Must be willing to undergo pharmacokinetic blood draws and frequent ECG monitoring on Days 1 and 2 of Cycle 1.
  • Must provide written, informed consent.

Who cannot join

  • More than three cytotoxic chemotherapy regimens.
  • Current treatment with any anticancer agent including but not limited to trastuzumab, aromatase inhibitors, or tamoxifen. Steroids, bisphosphonates and female hormone replacement therapy are allowed.
  • Documented central nervous system (CNS) metastasis or carcinomatous meningitis.
  • For patients in Cohorts 6 and 7, prior history of a serious allergic reaction to docetaxel; any chemotherapy containing Cremophor EL (used in drugs such as cyclosporine, etoposide, teniposide); or polysorbate 80 (the diluent for docetaxel).
  • Current pregnancy or lactation.
  • Current second malignancy except for non melanoma skin cancers, superficial bladder cancer, early cervical cancer or early prostate cancer not requiring treatment.
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  • Uncontrolled and/or serious medical conditions such as, but not limited to, active infection, symptomatic congestive heart failure, unstable angina, significant cardiac arrhythmia, significant neurological dysfunction, history of myocardial infarction or stroke within the 3 months prior to enrollment or any other condition which the Investigator feels would preclude protocol therapy.
  • Concomitant participation in another clinical trial of an experimental drug, vaccine or device.
  • Prior high dose chemotherapy requiring stem cell rescue.
  • Atrial fibrillation, left bundle branch block, or obligatory use of a cardiac pacemaker.
  • Currently on a drug known to increase the QTc duration.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Canada2 sites

  • Juravinski Cancer Center

    Hamilton, Ontario, L8V 5C2

  • BC Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

United States1 site

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase 1 Study Evaluating A Second Generation Antisense Oligonucleotide (OGX 427) That Inhibits Heat Shock Protein 27 (Hsp27

This study is for patients with cancer who have failed potentially curative treatments or for whose disease a curative treatment does not exist.

OGX-427 is an antisense product that inhibits expression of one of the heat shock proteins. Decreasing this heat shock protein (Hsp27) should result in down regulation of pathways implicated in cancer progression and development of resistance to treatment.

Read the detailed description

This study is for patients with breast, prostate, ovarian, non-small cell lung (NSCL) or bladder cancer who have failed potentially curative treatments or for whose disease a curative treatment does not exist.

OGX-427 is a second-generation ASO that inhibits expression of Hsp27. Hsp27 is one of the heat shock proteins. Hsp27 increases with cell stress, including cytotoxic chemotherapy, radiation therapy and hormone therapy and has been shown to inhibit cell death. Thus, decreasing Hsp27 as a cancer therapy is attractive as a therapy as it should result in down regulation of pathways implicated in cancer progression and development of resistance to treatment.

A number of in vitro and in vivo pharmacological studies have demonstrated that OGX-427 has single-agent activity in reducing Hsp27, inhibiting cell growth and inducing cell death in several human cancer cell lines. OGX-427 has also demonstrated chemosensitizing activity in studies using cell lines and animal models in combination with several cytotoxic drugs, including docetaxel.

Docetaxel (Taxotere®) has anticancer activity in breast, prostate, ovarian, non-small cell lung and bladder cancer. Docetaxel has been approved by Health Canada and the Food and Drug Administration for the treatment of patients with breast, prostate, ovarian and non-small cell lung cancer.

Conditions
Neoplasms
Being tested
OGX-427, Docetaxel
Keywords
Antisense, Heat Shock Protein
Medical subject headings
Neoplasms

What participants receive

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

  • OGX-427Drug

    OGX-427 injection at 200mg, 400mg, 600mg, 800mg or 1000mg once a week until withdrawn

  • DocetaxelDrug

    Also called Taxotere

    injection - 75 mg/M2 IV on Day 1 every 21 days for cohorts 6 \& 7 only, together with appropriate dose of OGX-427 until withdrawn from study

Study groups in NCT00487786
Study groupRoleWhat they receive
AExperimentalEach patient receives OGX-427
Receives: Drug: OGX-427; Drug: Docetaxel

What is being measured

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

  1. • To determine the maximum tolerated dose (MTD) of OGX-427 when administered as a single agent, up to a 1000 mg dose level.

    Measured: approximately 2 years

  2. • To further evaluate the safety profile at one dose level below the MTD derived for OGX-427 administered as a single agent and at the MTD level when OGX 427 is administered in combination with a taxane chemotherapy (docetaxel).

    Measured: approximately 2 years

Secondary outcomes (6)

  1. To determine the pharmacokinetic profile of OGX-427 when used as a single agent and when used in combination with a taxane.

    Measured: approximately 2 years

  2. To determine whether OGX-427 alone or when co-administered with a taxane alters ECG intervals and morphology.

    Measured: approximately 2 years

  3. To document objective responses and disease stabilization when OGX-427 is administered either alone or in combination with a taxane.

    Measured: approximately 2 years

  4. To assess for a biologically effective dose(s) of OGX-427 that inhibits Hsp27 and other related protein levels in patient's serum.

    Measured: approximately 2 years

  5. To assess for a biologically effective dose(s) of OGX-427 when used as a single agent that reduces serum PSA levels in patients with HRPC.

    Measured: approximately 2 years

  6. To estimate a biological dose with an acceptable toxicity profile for further evaluation in Phase 2 studies

    Measured: approximately 2 years

Timeline

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

  1. First posted19 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionJun 2011
  4. Study completionOct 2011

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00487786
Sponsor's protocol ID
OGX-427-01
Status last verified
Apr 2014
First submitted
15 Jun 2007
Last updated
18 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Chi KN, Yu EY, Jacobs C, Bazov J, Kollmannsberger C, Higano CS, Mukherjee SD, Gleave ME, Stewart PS, Hotte SJ. A phase I dose-escalation study of apatorsen (OGX-427), an antisense inhibitor targeting heat shock protein 27 (Hsp27), in patients with castration-resistant prostate cancer and other advanced cancers. Ann Oncol. 2016 Jun;27(6):1116-1122. doi: 10.1093/annonc/mdw068. Epub 2016 Feb 18.

    PubMed 27022067

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OGX-427 and Docetaxel in people with Neoplasms, run by Achieve Life Sciences at 3 sites in 2 countries.

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 15 inclusion and 11 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 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada, United States. 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?

• To determine the maximum tolerated dose (MTD) of OGX-427 when administered as a single agent, up to a 1000 mg dose level. (time frame: approximately 2 years). 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 NCT00487786, which also lists 1 linked publication.

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 18 Jan 2016.

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