Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Talabostat in Treating Patients With Metastatic Kidney Cancer

This study has been withdrawn prior to enrollment.
(Terminated for safety reasons)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Nebraska Identifier:
First received: June 20, 2007
Last updated: May 7, 2013
Last verified: May 2013

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.

Condition Intervention Phase
Kidney Cancer
Drug: talabostat mesylate
Procedure: diagnostic procedure
Procedure: enzyme inhibitor therapy
Procedure: flow cytometry
Procedure: laboratory biomarker analysis
Procedure: non-specific immune-modulator therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: At progression or death from any cause ]
    Kaplan-Meier method

  • Objective response rate [ Time Frame: At 9 and 12 evaluable patients ]
    Evaluable patients are those that have completed 4 cycles of treatment.

Secondary Outcome Measures:
  • Dose-limiting toxicity [ Time Frame: At end of each course ]
  • Adverse events as assessed by NCI CTCAE v3.0 [ Time Frame: At end of each course ]

Enrollment: 0
Study Start Date: December 2006
Study Completion Date: May 2007
Arms Assigned Interventions
Experimental: Talabostat
Talabostat 600 mcg PO QD x 14 days (21 day cycle); 2 cycles
Drug: talabostat mesylate Procedure: diagnostic procedure Procedure: enzyme inhibitor therapy Procedure: flow cytometry Procedure: laboratory biomarker analysis Procedure: non-specific immune-modulator therapy

Detailed Description:



  • 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.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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 syndrome)
  • 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00489710

Sponsors and Collaborators
University of Nebraska
National Cancer Institute (NCI)
Principal Investigator: Ralph Hauke, MD University of Nebraska
  More Information

Responsible Party: University of Nebraska Identifier: NCT00489710     History of Changes
Other Study ID Numbers: 401-05
CDR0000549510 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: June 20, 2007
Last Updated: May 7, 2013

Keywords provided by University of Nebraska:
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017