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A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma

Phase 2
19 Years
Not Enrolling
Kidney Cancer

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Trial Information

A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma



- Determine the response rate in patients with metastatic renal cell carcinoma treated
with talabostat mesylate.

- Determine the progression-free survival of patients treated with this drug.


- Determine the toxicity of this drug in these patients.

- Correlate changes in specific cytokine levels and peripheral blood flow cytometry with
progression-free survival.

OUTLINE: This is a nonrandomized study.

Patients receive oral talabostat mesylate once daily on days 1-14. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.

Blood samples are obtained from patients at baseline and after each course for biomarker
correlative studies. Samples are analyzed for serum cytokines and chemokines and for T-cell
subsets and NK cells by flow cytometry. Peripheral blood lymphocytes are obtained at
baseline and after course 1 for future assessment by gene microarray analysis.

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

- The following are considered nonmeasurable disease:

- Small lesions (longest diameter < 20 mm by conventional techniques or < 10
mm by spiral CT scan)

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusion

- Lymphangitis cutis or pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Progressed after ≥ 1 multikinase inhibitor regimen (i.e., sorafenib tosylate or
sunitinib malate)

- No history of CNS or brain metastasis


- ECOG performance status 0-2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- 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

- AST and 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


- See Disease Characteristics

- At least 4 weeks since prior systemic therapy and recovered

- Prior radiotherapy allowed as long as the lesion treated is not used to assess

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Description:

Kaplan-Meier method

Outcome Time Frame:

At progression or death from any cause

Safety Issue:


Principal Investigator

Ralph Hauke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

May 2007

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms