Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Lactoferrin

Immunomodulating Agents

polysaccharide-K

Talactoferrin alfa

Talactoferrin alfa (talactoferrin or TLF, also known as recombinant human lactoferrin, rhLF or talactoferrinum alfa) is a recombinant version of the glycoprotein expressed in and purified from Aspergillus niger var. awamori. Talactoferrin is structurally and functionally similar to native human lactoferrin. The structural equivalence of talactoferrin to native human lactoferrin has been demonstrated by a comparison of the 3-dimensional structure, molecular weight, biological activity and other physicochemical properties, and is known to differ only in the nature of glycosylation.

Placebo contains the same phosphate-based buffer used as the diluent for the talactoferrin solution. In addition, the placebo will contain FD\&C/EU grade dyes suitable for oral use to mimic the color of the vialed drug product.

Talactoferrin

Placebo

The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens.

Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer

FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens

Agennix

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Yenyun Wang, MD

Rajesh Malik, MD

Karen Reckamp

Missak Haigentz

Jeffrey Crawford

Davey Daniel

David Spigel

The purpose of the study is to determine whether the combination of talactoferrin, carboplatin and paclitaxel improves progression free survival and overall survival in patients with non-small cell lung cancer compared to the combination of paclitaxel and carboplatin alone

Safety and Efficacy of Talactoferrin in Addition to Standard Chemotherapy in Patients With Non-small Cell Lung Cancer

FORTIS-C: A Phase 3, Randomized, Placebo-controlled Study of Oral Talactoferrin in Combination With Carboplatin and Paclitaxel as First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Proteasome Inhibitors

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Immunologic Factors

Prospectively enrolled cohort of patients receiving single maintenance therapy with an immunomodulatory drug after Autologous Stem Cell Transplant for Multiple Myeloma

Prospectively enrolled cohort of patients receiving double maintenance therapy with the combination of an immunomodulatory drug and a proteasome inhibitor after Autologous Stem Cell Transplant for Multiple Myeloma.

This observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT

Autologous Stem Cell Transplant

ASCT recipients receiving maintenance therapy consisting of an Immunomodulatory agent (IMID) after ASCT transplant

Immunomodulatory Agent

ASCT recipients receiving maintenance therapy with a proteasome inhibitor in combination with an immunomodulatory drug after ASCT transplant

Proteasome Inhibitor

Garrett Welch

Garret Welch

Doris Hansen, MD

Melissa Alsina, MD

Rachid Baz, MD

Brandon Blue, MD

Jason Brayer, MD, PhD

Hien D Liu, MD

Jose Ochoa, MD

Taiga Nishihori, MD

Ken Shain, MD, PhD

Omar Castaneda, MD

Ciara Freeman, MD

The purpose of the study is to determine outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post Autologous Stem Cell Transplant (ASCT).

This non-interventional, cohort prospective research study will assess outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post ASCT.

Minimal Residual Disease (MRD) testing by Clonoseq will be performed in the peripheral blood of the patients at the same time points that MRD testing will be done in the bone marrow in addition to at 6 and 18 months.

Investigators will examine the impact gut microbiota on MRD status and racial ethnic differences in study population. Stool samples will be collected at baseline and 1- and 2-years post Autologous Stem Cell Transplant.

Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant

To determine rate of MRD conversion (positive to negative) in MM patients receiving an immunomodulatory drug in combination with a proteasome inhibitor as maintenance therapy 1-year post transplant.

PFS is defined as time from transplant to disease progression, death or last follow-up date, whichever comes first. PFS will be estimated by Kaplan-Meier method and 95% confidence interval

MRD testing by NGS Clonoseq in peripheral blood of participants and correlate with same testing in bone marrow

Adaptive Biotechnologies

H. Lee Moffitt Cancer Center and Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer	NCT00707304	Non Small Cell ...	Talactoferrin Placebo	18 Years -	Agennix
Safety and Efficacy of Talactoferrin in Addition to Standard Chemotherapy in Patients With Non-small Cell Lung Cancer	NCT00706862	Non Small Cell ...	Talactoferrin Placebo	18 Years -	Agennix
Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant	NCT05271630	Multiple Myelom...	Autologous Stem... Immunomodulator... Proteasome Inhi...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer	NCT00707304	Non Small Cell ...	Talactoferrin Placebo	18 Years -	Agennix
Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer	NCT00707304	Non Small Cell ...	Talactoferrin Placebo	18 Years -	Agennix
Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant	NCT05271630	Multiple Myelom...	Autologous Stem... Immunomodulator... Proteasome Inhi...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

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