Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Waldenstrom Macroglobulinemia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphoma, Non-Hodgkin

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Diffuse Large B-Cell Lymphoma

Primary Central Nervous System Lymphoma

Richter Syndrome

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Amino Acids

Venetoclax

Acalabrutinib

Zanubrutinib

Rituximab

Pirtobrutinib

Ibrutinib

Idelalisib

Antineoplastic Agents, Immunological

Immunologic Factors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Dose Escalation and determination of MTD; multiple dose levels of pirtobrutinib to be evaluated

Non-blastoid MCL patients treated with a prior BTK-inhibitor containing regimen.

CLL/SLL patients treated with prior therapy, BTK inhibitor naïve.

CLL/SLL patients treated with 2 or more prior regimens, including a BTK inhibitor-containing regimen.

WM patients treated with a prior BTK inhibitor-containing regimen.

MZL patients treated with a prior BTK inhibitor-containing regimen.

Defined as CLL/SLL or NHL not otherwise specified in Cohorts 1 through 6, inclusive of CLL/SLL, Richter's transformation, or low grade NHL with transformation, blastoid MCL, and patients with history of CNS involvement or primary CNS lymphoma. In the event the Sponsor electively closes Cohorts 2-4 prior to completion, patients with CLL/SLL who are ineligible to participate in or unable to access late phase studies of pirtobrutinib may be eligible to enroll in this cohort Diffuse large B-cell lymphoma (DLBCL) is excluded. MCL without prior BTK inhibitor treatment is excluded. Patients enrolling to Cohort 7 must have received one or more prior therapies or have no available approved therapy with demonstrated clinical benefit with the exception of untreated Richter's transformation, which is allowed.

Relapsed/Refractory CLL will receive the recommended Phase 2 dose of pirtobrutinib in combination with venetoclax

Relapsed/Refractory CLL will receive the recommended Phase 2 dose of pirtobrutinib in combination with venetoclax and rituximab

Patients to receive the recommended Phase 2 dose of pirtobrutinib

Donald Tsai, MD, PhD

This is an open-label, multi-center Phase 1/2 study of oral LOXO-305 (pirtobrutinib) in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.

This study includes 3 parts: Phase 1 (pirtobrutinib monotherapy dose escalation and dose expansion), Phase 1b (pirtobrutinib combination therapy dose expansion), and Phase 2 (pirtobrutinib monotherapy dose expansion). In Phase 1, patients will be enrolled using an accelerated titration design. The starting dose of pirtobrutinib in oral tablet form is 25 mg/day (e.g., 25 mg once daily \[QD\]). Once the MTD and/or RP2D is identified in Phase 1 dose escalation, enrollment will continue to Phase 1 dose expansion and can commence to Phase 1b (Arms A and B). For Phase 2, patients will be enrolled to one of seven Phase 2 dose expansion cohorts depending on tumor histology and prior treatment history. Cycle length will be 28 days.

A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL

A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)

Individual EORTC symptom scores range from 1 (not at all) to 4 (very much) with higher scores representing more severe symptom severity.

EORTC physical function item scores range from 1 (not at all) to 4 (very much) with higher scores indicating poorer functioning.The total EORTC physical functioning score ranges from 0-100 where a higher score indicates higher/healthier level of functioning.

Eli Lilly and Company

Loxo Oncology, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Nervous System Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Adenoma

Colonic Neoplasms

Breast Neoplasms

Lung Diseases

Thyroid Neoplasms

Thyroid Diseases

Head and Neck Neoplasms

Sarcoma

Endocrine Gland Neoplasms

Protein-Energy Malnutrition

Thyroid Cancer, Papillary

Respiratory Tract Diseases

Central Nervous System Neoplasms

Thoracic Neoplasms

Fibrosarcoma

Respiratory Tract Neoplasms

Bronchial Neoplasms

Carcinoma, Bronchogenic

Nervous System Neoplasms

Endocrine System Diseases

Myofibromatosis

Neoplasms, Connective and Soft Tissue

Adenocarcinoma

Adenocarcinoma, Papillary

Neoplasms, Glandular and Epithelial

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Papillary Thyroid Carcinoma

Thyroid Cancer, Medullary

Infantile Myofibromatosis

Herbal and Botanical

Cola

Phase 1- Dose Escalation and determination of MTD; multiple dose levels of LOXO-292 to be evaluated; Phase 2 - The MTD/recommended dose from Phase 1

LOXO-292

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Leo Mascarenhas

Margaret Macy

Ramamoorthy Nagasubramanian

Steven DuBois

Emily Greengard

Julia Glade Bender

Brian Turpin

Frank Balis

Alberto Pappo

Tanya Watt

Stephanie Fetzko

Douglas Hawkins

David Ziegler

Martin Campbell

Daniel Alexander Morgenstern

Karstend Nysom

Charlotte Rigaud

Cornelis Van Tilburg

Michela Casanova

Atushi Manabe

Ayumu Arakawa

Shuhei Karakawa

Katsutsugu Umeda

HyoungJin Kang

Raquel Hladun

Sara Stoneham

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.

This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, participants will be enrolled using a rolling 6 dose escalation scheme. The starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160 milligrams (mg) twice a day (BID). Once the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) is identified, participants will be enrolled to one of four phase 2 dose expansion cohorts depending on tumor histology and tumor genotype. Cycle length will be 28 days.

A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors

Tumor stage is described according to the Tumor, Node, Metastasis (TNM)Classification of malignant tumors of the Union for International Cancer Control (UICC)

Tumor margins after surgery are classified into four groups using the International Cancer Control (UICC)-R classification and the Intergroup Rhabdomyosarcoma Staging (IRS) systems: 1) Complete tumor resection with histologically free margins, 2) Macroscopic resection but invaded margins on histology, 3)Macroscopic residual tumor and 4) Distant metastatic tumor.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL	NCT03740529	Chronic Lymphoc... Waldenstrom Mac... Mantle Cell Lym... Marginal Zone L... B-cell Lymphoma Small Lymphocyt...	Pirtobrutinib Venetoclax Rituximab	18 Years -	Eli Lilly and Company
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors	NCT03899792	Medullary Thyro... Infantile Myofi... Infantile Fibro... Papillary Thyro... Soft Tissue Sar...	LOXO-292	6 Months - 21 Years	Eli Lilly and Company
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors	NCT03899792	Medullary Thyro... Infantile Myofi... Infantile Fibro... Papillary Thyro... Soft Tissue Sar...	LOXO-292	6 Months - 21 Years	Eli Lilly and Company
A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL	NCT03740529	Chronic Lymphoc... Waldenstrom Mac... Mantle Cell Lym... Marginal Zone L... B-cell Lymphoma Small Lymphocyt...	Pirtobrutinib Venetoclax Rituximab	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for loxo

Every month we try and update this database with for loxo cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for loxo

Every month we try and update this database with for loxo cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for loxo cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.