Kidney CancerPhase 2NCT00489710
Talabostat in Treating Patients With Metastatic Kidney Cancer
A Phase 2 study testing talabostat mesylate, enzyme inhibitor therapy and flow cytometry in people with Kidney Cancer, run by University of Nebraska.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 120 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- talabostat mesylate, enzyme inhibitor therapy and flow cytometry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to 30 May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
About this study
Official title: A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma
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.
Read the detailed description
OBJECTIVES:
Primary
- 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.
Secondary
- 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 natural killer (NK) cells by flow cytometry. Peripheral blood lymphocytes are obtained at baseline and after course 1 for future assessment by gene microarray analysis.
- Conditions
- Kidney Cancer
- Being tested
- talabostat mesylate, enzyme inhibitor therapy, flow cytometry, laboratory biomarker analysis, non-specific immune-modulator therapy
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talabostat mesylateDrug
Also called Val-boroPro
enzyme inhibitor therapyBiological
flow cytometryDiagnostic test
laboratory biomarker analysisDiagnostic test
non-specific immune-modulator therapyBiological
| Study group | Role | What they receive |
|---|---|---|
| Talabostat | Experimental | Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles Receives: Drug: talabostat mesylate; Biological: enzyme inhibitor therapy; Diagnostic Test: flow cytometry; Diagnostic Test: laboratory biomarker analysis; Biological: non-specific immune-modulator therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Evaluable patients are those that have completed 4 cycles of treatment.
Measured: 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
Any grade 3-4 non-haematological or grade 4 haematological toxicity at least possibly related to treatment
Measured: From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Adverse events
Adverse events as assessed by NCI CTCAE v3.0
Measured: From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startDec 2006 (estimated)
- Primary completion30 May 2007
- Study completion30 May 2007
Why it stopped: safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ralph Hauke, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489710
- Sponsor's protocol ID
- 0401-05-FB
- Status last verified
- Aug 2023
- First submitted
- 20 Jun 2007
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00489710
- Acronym / sponsor ID
- 0401-05-FB
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: safety reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Dec 2006 (estimated)
- Primary completion
- 30 May 2007 (actual)
- Study completion
- 30 May 2007 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- 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.
Secondary
- 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 natural killer (NK) cells by flow cytometry. Peripheral blood lymphocytes are obtained at baseline and after course 1 for future assessment by gene microarray analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Talabostat | Experimental | Drug: talabostat mesylate, Biological: enzyme inhibitor therapy, Diagnostic Test: flow cytometry, Diagnostic Test: laboratory biomarker analysis, Biological: non-specific immune-modulator therapyTalabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles |
Who may qualify
- Ages
- 19 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| talabostat mesylateAlso: Val-boroPro | Drug | Talabostat |
| enzyme inhibitor therapy | Biological | Talabostat |
| flow cytometry | Diagnostic test | Talabostat |
| laboratory biomarker analysis | Diagnostic test | Talabostat |
| non-specific immune-modulator therapy | Biological | Talabostat |
Primary outcome
Objective response rate
Time frame: 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.
Evaluable patients are those that have completed 4 cycles of treatment.
2 secondary outcomes
Dose-limiting toxicity
Time frame: From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Adverse events
Time frame: From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Hauke, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing talabostat mesylate, enzyme inhibitor therapy and flow cytometry in people with Kidney Cancer, run by University of Nebraska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.