Clinical trial · Interventional
AEG35156 and Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Solid Tumors
A Phase I Study of AEG35156 Given as a 2 Hour Intravenous Infusion in Combination With Docetaxel in Patients With Solid Tumours
NCT00372736CI-TRIAL-00068518completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AEG35156 | Drug | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| flow cytometry | Other | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose of AEG35156 in combination with docetaxel
- timeFrame
- 2-3 years
- description
- 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)
- measure
- Recommended phase II dose
- timeFrame
- 2-3 years
- description
- RPTD for AEG35156 defined as one dose lower than MTD
Secondary outcomes (5)
- measure
- Toxicities
- timeFrame
- Every 3 weeks
- description
- Toxicities evaluated according to NCI CTCAE v3.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.