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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00357747

AEG35156 and Docetaxel in Treating Patients With Solid Tumors

A Phase 1 study testing AEG35156 and docetaxel in people with Unspecified Adult Solid Tumor, Protocol Specific, run by NCIC Clinical Trials Group at 3 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

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AEG35156 may help docetaxel work better by making tumor cells more sensitive to the drug. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
AEG35156 and docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesCanada
Study dates
9 Jun 2005to 7 Jun 2010
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor
  • Locally advanced, metastatic, or recurrent disease that is refractory to standard curative therapy or for which no curative therapy exists
  • Clinically and/or radiographically documented disease
  • Docetaxel single-agent therapy must be a reasonable treatment option
  • No newly diagnosed CNS metastases
  • Previously treated, intracranial disease that has been stable for ≥ 6 months allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin normal
  • Creatinine normal
  • AST and ALT ≤ 1.5 times upper limit of normal
  • PT or INR normal
  • PTT normal
  • No known bleeding disorder
  • No preexisting peripheral neuropathy ≥ grade 2
  • No prior serious allergic reaction to taxanes (e.g., paclitaxel or docetaxel)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious illness or medical condition that would be aggravated by treatment or preclude study requirements, including any of the following:
  • Serious uncontrolled infection
  • Significant cardiac dysfunction
  • Significant neurological disorder

PRIOR CONCURRENT THERAPY:

  • No more than 2 prior chemotherapy regimens for metastatic or recurrent disease
  • No more than 1 prior adjuvant chemotherapy regimen
  • No more than 1 prior taxane-containing regimen
  • At least 4 weeks since prior chemotherapy and recovered
  • At least 4 weeks since prior external-beam radiotherapy provided < 30% of marrow-bearing areas are irradiated*
  • At least 4 weeks since prior investigational agents or new anticancer therapy
  • At least 2 weeks since prior hormonal therapy or immunotherapy
  • At least 2 weeks since prior surgery and recovered
  • No prior nephrectomy
  • No concurrent anticoagulant therapy in therapeutic doses
  • Nontherapeutic dose anticoagulant therapy (e.g., 1 mg warfarin once daily) allowed
  • No other concurrent experimental drugs or anticancer therapy
  • No other concurrent cytotoxic therapy or radiotherapy
  • Small-volume, nonmyelosuppressive palliative radiotherapy allowed NOTE: *Exceptions are made for prior low-dose non-myelosuppressive radiotherapy

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • McGill University - Dept. Oncology

    Montreal, Quebec, H2W 1S6

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Phase I Study of AEG35156 in Combination With Docetaxel in Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AEG35156 may help docetaxel work better by making tumor cells more sensitive to the drug.

PURPOSE: This phase I trial is studying the side effects and best dose of AEG35156 when given together with docetaxel in treating patients with solid tumors.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose and define the recommended phase II dose of AEG35156 in combination with docetaxel in patients with solid tumors.

Secondary

  • Determine the qualitative and quantitative toxicities of AEG35156 and docetaxel and define duration and reversibility of those toxicities.
  • Determine the pharmacokinetic profile of this regimen.
  • Assess, preliminarily, the antitumor activity of this regimen in patients with measurable disease.
  • Assess the pharmacodynamic effects of AEG35156 administration on X-linked inhibitor of apoptosis protein (XIAP) levels and apoptosis in peripheral blood mononuclear cells and, in selected patients, in tumor tissue.
  • Evaluate M30/M65 cytokeratin 18 level, a marker of apoptosis/necrosis of epithelial tumors, in these patients.

OUTLINE: This is a multicenter, open-label, dose-escalation study of AEG35156.

Patients receive AEG35156 IV continuously on days -2 and -1. Patients then receive AEG35156 IV continuously over 24 hours on days 1, 8, and 15. Beginning with course 2, patients also receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of AEG35156 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Blood is collected at baseline and periodically during study treatment for pharmacokinetic and pharmacodynamic assessment.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Being tested
AEG35156, docetaxel
Keywords
unspecified adult solid tumor, protocol specific

What participants receive

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

  • AEG35156Drug

    After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.

  • docetaxelDrug

    After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.

Study groups in NCT00357747
Study groupRoleWhat they receive
AEG35156 plus docetaxelExperimentalNot described
Receives: Drug: AEG35156; Drug: docetaxel

What is being measured

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

  1. Safety and toxicity evaluated according to the NCI CTCAE version 3.0

    Measured: Every 3 weeks

  2. Response and progression using RECIST criteria

    Measured: Every 6 weeks

  3. Response duration measured from the time complete response or partial response (whichever is first recorded) is documented until the first date that recurrent or progressive disease is objectively documented

    After completion of protocol therapy, patients with PR/CR ongoing assessed q3 months until relapse.

    Measured: Every 3 months

  4. Stable disease duration measured from the time of start of therapy until the criteria for progression are met

    After completion of protocol therapy, patients with ongoing SD assess q 3months until progression.

    Measured: Every 3 months

  5. Pharmacokinetics

    Measured: cycle 1 and 2

Timeline

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

  1. First posted27 Jul 2006 (estimated)
  2. Study start9 Jun 2005
  3. Primary completion26 Sep 2006
  4. Study completion7 Jun 2010

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00357747
Sponsor's protocol ID
I166
Other IDs
CAN-NCIC-IND166, CDR0000481440
Status last verified
Apr 2020
First submitted
26 Jul 2006
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AEG35156 and docetaxel in people with Unspecified Adult Solid Tumor, Protocol Specific, run by NCIC Clinical Trials Group at 3 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?

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 4 Aug 2023. 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. 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 and toxicity evaluated according to the NCI CTCAE version 3.0 (time frame: Every 3 weeks). The study lists 5 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 NCT00357747.

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 4 Aug 2023.

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