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

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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



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


- 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.

Inclusion Criteria


- 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


- 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


- 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)

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and toxicity evaluated according to the NCI CTCAE version 3.0

Outcome Time Frame:

Every 3 weeks

Safety Issue:


Principal Investigator

Gerald Batist, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jewish General Hospital


Canada: Health Canada

Study ID:




Start Date:

April 2005

Completion Date:

September 2006

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms