Clinical trial · Interventional
AEG35156 and Docetaxel in Treating Patients With Solid Tumors
A Phase I Study of AEG35156 in Combination With Docetaxel in Patients With Solid Tumors
NCT00357747CI-TRIAL-00068557completedPhase 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 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AEG35156 | Drug | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AEG35156 plus docetaxel
- interventionNames
- Drug: AEG35156
- Drug: docetaxel
Primary outcomes (5)
- measure
- Safety and toxicity evaluated according to the NCI CTCAE version 3.0
- timeFrame
- Every 3 weeks
- measure
- Response and progression using RECIST criteria
- timeFrame
- Every 6 weeks
- measure
- 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
- timeFrame
- Every 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 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 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
References
Publications (0)
Data not yet available
No reference posted for this study.