NCT00489710

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

June 20, 2007

Last Update Submit

August 18, 2023

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancerrecurrent renal cell cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Evaluable patients are those that have completed 4 cycles of treatment.

    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.

Secondary Outcomes (2)

  • Dose-limiting toxicity

    From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

  • Adverse events

    From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Study Arms (1)

Talabostat

EXPERIMENTAL

Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles

Drug: talabostat mesylateBiological: enzyme inhibitor therapyDiagnostic Test: flow cytometryDiagnostic Test: laboratory biomarker analysisBiological: non-specific immune-modulator therapy

Interventions

talabostat mesylateDRUG
Also known as: Val-boroPro
Talabostat
enzyme inhibitor therapyBIOLOGICAL
Talabostat
flow cytometryDIAGNOSTIC_TEST
Talabostat
laboratory biomarker analysisDIAGNOSTIC_TEST
Talabostat
non-specific immune-modulator therapyBIOLOGICAL
Talabostat

Eligibility Criteria

Age19 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +7 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

PT-100 dipeptideFlow Cytometry

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Ralph Hauke, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 21, 2007

Study Start

December 1, 2006

Primary Completion

May 30, 2007

Study Completion

May 30, 2007

Last Updated

August 22, 2023

Record last verified: 2023-08