Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

LGH447

Novartis Pharmaceuticals

This is a multi-center, open-label, dose escalation, Phase 1 study of oral LGH447 in Japanese patients with relapsed and/or refractory multiple myeloma for which no standard effective treatment options exist.

The study consists of a dose escalation part to estimate the maximum tolerated dose and/or the recommended dose for expansion and a dose expansion part to further assess safety and preliminary anti-cancer activity of LGH447 at the maximum tolerated dose and/or the recommended dose for expansion.

Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies

A Multi-center, Open-label, Dose Escalation, Phase 1 Study of Oral LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies

Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients

Adverse events, serious adverse events, changes in laboratory values, and electrocardiograms

PK parameters such as AUC, Cmax, Tmax, T1/2. Cycle = 28 days

Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.

LM716

This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.

This is a phase I, open-label, dose-escalation study to establish the MTD and/or RDE of LJM716 as single agent in Japanese patients that have advanced solid tumors. The study consists of a dose escalation part and a dose expansion part.

A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Renal Cell

Adenocarcinoma

Neoplasms, Glandular and Epithelial

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

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Lapatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Pazopanib monotherapy or in combination with lapatinib

pazopanib

GSK Clinical Trials

This is a two part phase I study in Japanese patients that will determine the safety, tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination with lapatinib.

Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors

A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors

The safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), and changes in vital signs and laboratory values.

The pharmacokinetic parameters AUC0-24, AUC0-inf (Day 1 only), Cmax, tmax, and t1/2 of pazopanib and its four metabolites. To determine if target trough plasma concentration of pazopanib of 20,000 ng/ml is achieved.

Assessments of tumor response will be obtained every 9 weeks and will be recorded as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).

GlaxoSmithKline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies	NCT02160951	Multiple Myelom...	LGH447	18 Years -	Novartis
A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors	NCT01911936	Neoplasms	LM716	18 Years -	Novartis
A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors	NCT01911936	Neoplasms	LM716	18 Years -	Novartis
Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors	NCT00516672	Carcinoma, Rena...	pazopanib Lapatinib	20 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for japanese patients,