Kidney Cancer Clinical Trial
Official title:
A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma
Verified date | August 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 30, 2007 |
Est. primary completion date | May 30, 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 120 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Dose-limiting toxicity | Any grade 3-4 non-haematological or grade 4 haematological toxicity at least possibly related to treatment | From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | |
Secondary | Adverse events | Adverse events as assessed by NCI CTCAE v3.0 | From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
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