Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Recurrence

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Immunomodulating Agents

Enzyme Inhibitors

Immunologic Factors

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

talabostat mesylate

enzyme inhibitor therapy

flow cytometry

laboratory biomarker analysis

non-specific immune-modulator therapy

Ralph Hauke, MD

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.

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.

Talabostat in Treating Patients With Metastatic Kidney Cancer

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

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

Any grade 3-4 non-haematological or grade 4 haematological toxicity at least possibly related to treatment

Adverse events as assessed by NCI CTCAE v3.0

University of Nebraska

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

BXCL701 will be administered for one week at a dose of 0.2 mg, twice daily (BID). If BXCL701 is well-tolerated after the first week of treatment, the dose will be increased to 0.3mg BID for a total daily dose of 0.6mg to all patients for the second week of treatment.

BXCL701 tablets dosage strengths include 0.2mg and 0.05mg tablets for oral administration.

Patients are to self-administer the prescribed number of BXCL701 tablets for a total daily dose of 0.6 mg. BXCL701 should not be taken on an empty stomach.

Daily blood pressure monitoring will be performed during the dosing period. Administration of at least 1L of intravenous (IV) fluids is required on Day 1.

On days when pharmacokinetic (PK) assessments are being performed, BXCL701 should be administered at the study center and should be administered at (approximately) the same time of day on each treatment day.

Talabostat Mesylate

A study to assess the biochemical and immunomodulatory effects of BXCL701 in pancreatic cancer.

This is a Phase 0 or "window of opportunity" study where paired specimen analysis, taken before and after drug exposure, will permit the evaluation of target modulation and assessment of immune effector cell infiltration into the tumor and the generation of relevant immune cytokines.

In this study, BXCL701 will be administered at a dose of 0.3 mg, twice daily for a total daily dose of 0.6mg (the previously defined maximum tolerated dose \[MTD\] of the drug), to all patients for a short period of 14 days. This study is designed to assess the biochemical and immunomodulatory effects of BXCL701 in pancreatic cancer.

A Pilot Study of BXCL701 in Patients With Pancreatic Cancer

A Pilot Proof of Mechanism Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases (DPPs), in Patients With Pancreatic Cancer

To measure how BXCL701 effects the tumor by measuring the rate of tumor cell death or the reduction of tumor cell growth. This will be measured by scans and blood work.

assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events

Measure the rate of cancer cell death measured by histological staining methods of post-treatment biopsied tissue.

Genomic analysis is the identification, measurement or comparison of genomic features such as DNA sequence, structural variation, gene expression, or regulatory and functional element annotation at a genomic scale.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Talabostat in Treating Patients With Metastatic Kidney Cancer	NCT00489710	Kidney Cancer	talabostat mesy... enzyme inhibito... flow cytometry laboratory biom... non-specific im...	19 Years - 120 Years	University of Nebraska
A Pilot Study of BXCL701 in Patients With Pancreatic Cancer	NCT04123574	Cancer of Pancr... Cancer of the P... Neoplasms, Panc... Pancreas Cancer Pancreatic Canc...	Talabostat Mesy...	18 Years - 75 Years	BioXcel Therapeutics Inc

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