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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00372736

AEG35156 and Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Solid Tumors

A Phase 1 study testing AEG35156, docetaxel and protein expression analysis 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 years and older
What is being tested?
AEG35156, docetaxel and protein expression analysis
Type of treatment
Injection or infusion
How many people
27 participants
Where
3 sitesCanada
Study dates
27 Jul 2006to 6 Jan 2012
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

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 radiologically documented disease
  • Treatment with single-agent docetaxel is a reasonable treatment option
  • No newly diagnosed CNS metastases
  • Previously treated and stable (≥ 6 months) intracranial disease allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • PT or INR and PTT normal
  • Creatinine normal
  • Bilirubin normal
  • AST and ALT ≤ 1.5 times upper limit of normal (ULN)
  • Gamma-glutamyl transferase ≤ 3 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No underlying serious illness or medical condition that might be aggravated by treatment or might interfere with study treatment, including, but not limited to, the following:
  • Serious uncontrolled infection
  • Significant cardiac dysfunction
  • Significant neurological disorder that would impair the ability to obtain informed consent
  • No known bleeding disorders
  • No prior serious allergic reaction to taxane (paclitaxel or docetaxel)
  • No pre-existing peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior chemotherapy and recovered
  • At least 2 weeks since prior hormonal therapy or immunotherapy
  • At least 4 weeks since prior external-beam radiotherapy to < 30% of marrow-bearing areas
  • Low-dose, nonmyelosuppressive radiotherapy allowed
  • At least 2 weeks since prior surgery and recovered
  • More than 4 weeks since prior investigational agents or new anticancer therapy
  • No prior nephrectomy
  • No other concurrent chemotherapy
  • No concurrent radiotherapy
  • Small-volume, non-myelosuppressive palliative radiotherapy allowed
  • No other concurrent experimental drugs or anticancer therapy
  • No concurrent therapeutic dose anticoagulant therapy
  • Non-therapeutic dose anticoagulant therapy (i.e., 1 mg daily oral warfarin) allowed

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 Given as a 2 Hour Intravenous Infusion in Combination With Docetaxel in Patients With Solid Tumours

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 locally advanced, metastatic, or recurrent solid tumors.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose and define a recommended phase II dose of AEG35156 in combination with docetaxel in patients with locally advanced, metastatic, or recurrent solid tumors.

Secondary

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

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

Patients receive AEG35156 IV over 2 hours on days -1, 0, 1, 8, and 15 during course 1 and on days 1, 8, and 15 of all subsequent courses. Patients also receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days 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. Additional patients receive AEG35156 at the recommended phase II dose (RPTD).

Blood is drawn periodically for pharmacokinetic and pharmacodynamic studies. Samples are examined by flow cytometry, immunoenzyme methods, and reverse transcriptase-polymerase chain reaction for biological markers. Tumor tissue (archival and fresh) is collected from patients treated at the RPTD and examined by immunohistochemical methods and biological marker analysis.

After completion of study treatment, all patients are followed at 4 weeks. Patients with response or stable disease ongoing are followed every 3 months thereafter until relapse/progression. Patients with protocol-related toxicity also followed q 3 months until resolution to ≤ grade 2.

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

Being tested
AEG35156, docetaxel, protein expression analysis, reverse transcriptase-polymerase chain reaction, flow cytometry
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.

  • protein expression analysisGenetic

    Cycle 1: Pre-dose on Days -2, 1, 8 and 15; repeat every 2-4 days if LFTs > 5 x ULN1 Cycle 2: Prior to each infusion; repeat every 2-4 days if LFTs > 5 x ULN1

  • reverse transcriptase-polymerase chain reactionGenetic

    Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.

  • flow cytometryOther

    Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.

  • immunoenzyme techniqueOther

    Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.

  • immunohistochemistry staining methodOther

    The plasma concentration/ time data will be analysed using non-compartmental methods. The pharmacokinetic parameters to be determined for AEG35156 include the maximum observed plasma concentration (Cmax), the half-life (T1/2), and mean residence time (MRT).

  • laboratory biomarker analysisOther

    The plasma concentration/ time data will be analysed using non-compartmental methods. The pharmacokinetic parameters to be determined for AEG35156 include the maximum observed plasma concentration (Cmax), the half-life (T1/2), and mean residence time (MRT).

What is being measured

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

  1. Maximum tolerated dose of AEG35156 in combination with docetaxel

    Doses of AEG35156 escalated as shown in protocol section 4.3 in patient cohorts given a fixed dose of docetaxel. MTD defined as that dose level at which ≥ 2/6 patients experienced DLT (as defined in protocol section 4.6)

    Measured: 2-3 years

  2. Recommended phase II dose

    RPTD for AEG35156 defined as one dose lower than MTD

    Measured: 2-3 years

Secondary outcomes (5)

  1. Toxicities

    Toxicities evaluated according to NCI CTCAE v3.0

    Measured: Every 3 weeks

  2. Pharmacokinetic profile

    Venous blood samples for determination of AEG35156 concentration obtained on all patients during cycle 1 and 2 as per protocol section 17.2

    Measured: Each cycle

  3. Antitumor activity

    All patients with measurable disease at baseline evaluated for response using RECIST criteria as described in protocol section 10.0

    Measured: Every 6 weeks

  4. Pharmacodynamic effects of AEG35156 on X-linked inhibitor of apoptosis levels and apoptosis in peripheral blood mononuclear cells and tumor tissue

    Venous blood samples collected for PD studies as described in protocol Section 17.0. Fresh tissue biopsies also collected in patients entered at the RPTD.

    Measured: Each cycle

  5. M30/M65 cytokeratin 18 level

    Venous blood samples collected for determination of M30/M65 cytokeratin 18 and nucleosomal DNA as described in protocol section 17.0

    Measured: Each cycle

Timeline

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

  1. First posted7 Sep 2006 (estimated)
  2. Study start27 Jul 2006
  3. Primary completion24 Mar 2009
  4. Study completion6 Jan 2012

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00372736
Sponsor's protocol ID
I166B
Other IDs
CAN-NCIC-IND166B, CDR0000486837
Status last verified
Apr 2020
First submitted
6 Sep 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, docetaxel and protein expression analysis 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?

Maximum tolerated dose of AEG35156 in combination with docetaxel (time frame: 2-3 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 NCT00372736.

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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