852A

Jeffrey Miller, MD

Study 1493-852A is a phase 1 study with the primary objective of determining safety and the highest tolerated dose of an experimental immune response modifier administered intravenously to patients with solid organ tumors not responsive to currently available treatments. The secondary objective of the study is to monitor the tumor response to this form of treatment.

Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors

Phase I, Open Label Safety, Pharmacokinetic, and Pharmacodynamic Dose Escalation/De-escalation Study of 852A Administered Intravenously to Subjects With Refractory Solid Organ Tumors

Pfizer

Masonic Cancer Center, University of Minnesota

Jeffrey Miller, M.D.

Antineoplastic Agents

All Drugs and Chemicals

Lisavanbulin

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

BAL101553

Marc Engelhardt, MD

First in human, open-label, sequential dose escalation and expansion study of intravenous BAL101553 in adult patients with advanced solid tumors.

An Open-Label Study of Intravenous BAL101553 in Adult Patients With Solid Tumors

An Open-Label Phase I/IIa Study of Intravenous BAL101553 in Adult Patients With Advanced Solid Tumors

First-cycle dose limiting toxicities (DLT)

Incidence of adverse events, laboratory abnormalities, clinically significant changes in vital signs or ECG assessments

BAL101553 and BAL27862 PK parameters including (but not limited to): Cmax (maximum observed plasma concentration), AUC (area under the concentration time curve), half-life, volume of distribution

Exploratory assessment of baseline levels and change from baseline in the number of circulating tumor cells and other biomarkers

Basilea Pharmaceutica

Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Recurrence

Adenocarcinoma

Sarcoma

Mesothelioma

Mesothelioma, Malignant

Uterine Neoplasms

Carcinoid Tumor

Soft Tissue Sarcoma

Malignant Mesothelioma

Karl Williams, M.D.

The purpose of this research study is to collect information from patient's medical records that had a test called ChemoFx® ordered and to understand how doctors may have used the results of the ChemoFx® to treat patients with cancer.

While studies support the clinical use of ChemoFx® in cancer patients, additional data are needed to further assess the utilization of this product in clinical practice. Such post-market data and information could be employed for product improvement as well as for the development of standards and regulations. This is a multicenter registry study of 3,000 patients with solid tumors. The study is not randomized, nor is it interventional in that the treating physician is free to choose how to employ ChemoFx® results in the clinical management of individual patients. Sites will be selected by Precision's clinical trials team based on past commercial usage of ChemoFx®.

Subjects who may be enrolled in this study are those who have been diagnosed with a solid tumor malignancy and for whom ChemoFx® has been ordered. ChemoFx® is ordered through the normal commercial process and is therefore billed to the patient's medical insurance.

All subjects will be appropriately consented before any study-specific data are collected. A limited dataset of patient demographics, oncology history, and therapeutic intervention will be collected in addition to ChemoFx® assay usage. Subjects will be treated based on the medical judgment of their treating physician(s). Patient survival data will be collected up to five years following the ChemoFx® commercial order. Additional disease progression data may be collected by Precision's CRAs at participating sites.

Optional Cell Research

Informed consent will be obtained to document subject's consent to use excess cells remaining in Precisions' commercial laboratory for additional research. This portion of the study may involve DNA, RNA, and proteomic research. To ensure the anonymity of each subject, any identifiers that would link the sample to the subject will be removed. The samples would then have gene expression profiling and or quantitative protein expression analysis performed. The goal of the research would be to identify a set of informative genes, intermediaries, and proteins and develop predictive algorithm(s) that seek to link the expression level of the gene, gene signature, intermediary, or protein to the clinical outcome of the patient. This portion of the study does not require any additional subject procedures. Neither physicians nor their patients will receive the results of the research performed. Results will not be placed in the subjects health care records and will not affect their medical care.

DNA, RNA, and proteomic research will be conducted on excess tissue cells.

A Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study

A Multicenter, Post-Market Follow-up Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study

Precision Therapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors	NCT00095160	Neoplasms	852A	18 Years -	Masonic Cancer Center, University of Minnesota
An Open-Label Study of Intravenous BAL101553 in Adult Patients With Solid Tumors	NCT01397929	Solid Organ Tum...	BAL101553	18 Years -	Basilea Pharmaceutica
An Open-Label Study of Intravenous BAL101553 in Adult Patients With Solid Tumors	NCT01397929	Solid Organ Tum...	BAL101553	18 Years -	Basilea Pharmaceutica
A Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study	NCT01271959	Solid Organ Tum...		18 Years -	Precision Therapeutics

Spots Global Cancer Trial Database for solid organ tumors