Clinical trial · Interventional
Talabostat in Treating Patients With Metastatic Kidney Cancer
A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma
NCT00489710CI-TRIAL-00068992withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): safety reasons
Summary
Brief summary (as posted)
RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well talabostat works in treating patients with metastatic kidney cancer.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzyme inhibitor therapy | Biological | — | UNRESOLVED |
| flow cytometry | Diagnostic Test | — | UNRESOLVED |
| laboratory biomarker analysis | Diagnostic Test | — | UNRESOLVED |
| non-specific immune-modulator therapy | Biological | — | UNRESOLVED |
| talabostat mesylate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Talabostat
- description
- Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles
- interventionNames
- Drug: talabostat mesylate
- Biological: enzyme inhibitor therapy
- Diagnostic Test: flow cytometry
- Diagnostic Test: laboratory biomarker analysis
- Biological: non-specific immune-modulator therapy
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- After 9 and 12 evaluable patients (126 to 168 days of total treatment). Each course is 14 days and repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- description
- Evaluable patients are those that have completed 4 cycles of treatment.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria * Pathologic diagnosis of renal cell carcinoma (clinical confirmation of metastatic disease required) * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * Progressed after ≥ 1 multikinase inhibitor regimen (i.e., sorafenib tosylate or sunitinib malate) * No history of central nervous system or brain metastasis * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Absolute neutrophil count (ANC) ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8.5 g/dL (no packed red blood cell transfusions within the past 4 weeks) (epoetin alfa support allowed) * Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (unless due to Gilbert's syndrome) * aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3 times ULN * Creatinine \< 2.0 mg/dL * No active serious infections * No other malignancy within the past 5 years except basal cell or nonmetastatic squamous cell skin cancer or carcinoma in situ of the cervix * No comorbidity or concurrent condition that would interfere with protocol assessments or procedures * No ongoing coagulopathy * At least 4 weeks since prior systemic therapy and recovered * Prior radiotherapy allowed as long as the lesion treated is not used to assess response * No prior radiotherapy to \> 50% of the bone marrow * No prior radiotherapy to index lesions unless there is clearly progressive disease within the irradiated area OR measurable disease outside the irradiated area Exclusion Criteria * History of CNS or brain metastasis * Pregnant, nursing or planning on becoming pregnant * Active serious infections * Malignancy within the past 5 years except basal cell or nonmetastatic squamous cell skin cancer or carcinoma in situ of the cervix * comorbidity or concurrent condition that would interfere with protocol assessments or procedures
References
Publications (0)
Data not yet available
No reference posted for this study.