Clinical trial · Interventional
Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies
A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and MTD of GRN163L in Patients With Refractory or Relapsed Solid Tumor Malignancies
NCT00310895CI-TRIAL-00020330completedPhase 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)
The purpose of this study is to determine the safety and the maximum tolerated dose of GRN163L administration in treating patients with refractory or relapsed solid tumor malignancies.
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 |
|---|---|---|---|
| Solid Tumor Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imetelstat Sodium (GRN163L) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- Treatment Schedule 3 will consist of dosing on Days 1, 4, 8, and 11 of each 21 day cycle (3 weeks equals 1 cycle) and Treatment Schedule 4 will consist of dosing on Day 1 of each 28 day cycle (4 weeks equals 1 cycle)
- interventionNames
- Drug: Imetelstat Sodium (GRN163L)
Primary outcomes (1)
- measure
- Safety, DLT, and MTD
- timeFrame
- Measured during the first cycle of treatment
Secondary outcomes (1)
- measure
- PK profile and disease response
- timeFrame
- Within the first 2 cycles of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Male or female * Measurable or evaluable solid tumor malignancy * Relapsed, refractory, locally advanced, or metastatic disease * Disease refractory to or not amenable to standard therapy * Karnofsky performance status 70-100% * Life expectancy 3 months or greater Exclusion Criteria: * Pregnant or lactating women * Primary central nervous system(CNS) malignancy or active CNS metastases * Hematologic malignancy * Chemotherapy within 4 weeks prior to study * Mitomycin C, nitrosoureas within 6 weeks prior to study * High dose chemotherapy with stem cell support within 6 months prior to study * Signal transduction inhibitors, monoclonal antibodies, etc. within 4 weeks prior to study * Systemic hormonal therapy within 4 weeks prior to study * Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study * Radiotherapy within 4 weeks prior to study * Significant cardiovascular disease * Serious/active infection * Major surgical procedures within 2 weeks
References
Publications (0)
Data not yet available
No reference posted for this study.