Neoplasms

All Conditions

Rare Diseases

Sarcoma

Liposarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Adipose Tissue

Soft Tissue Sarcoma

orally day 1-10 each 28-day cycle, 3 cycles

RO5045337

Clinical Trials

This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.

A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery

Hoffmann-La Roche

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Multiple escalating oral doses, Days 1-5 (1-3) of each 28-day cycle, up to 6 cycles

60 mg/m2 (75 mg/m2, 50 mg/m2) iv on Day 1 of each 28-day cycle, up to 6 cycles

doxorubicin

This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.

A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma

A Multi-center, Open-label Phase IB Study of Escalating Doses of RO5045337, an Oral Small Molecule MDM2 Antagonist, in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Blast Crisis

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

This study will determine the maximum tolerated dose of RO5045337 and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with hematologic neoplasms. A first cohort of patients will receive the starting dose of 20mg/m2/day orally, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. Different formulations of RO5045337 will be tested and the food effect evaluated. The anticipated time on study treatment is until disease progression or intolerable toxicity.

A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.

An Open Label Study to Investigate the Maximum Tolerated Dose of RO5045337 in Patients With Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myelogenous Leukemia (CML) in Blast Phase, or Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL / SCLL)

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Chronic Myeloproliferative Disorders

Participants will continue the most similar dose and formulation available (which does not exceed the MTD or the maximum safely administered dose for that formulation during Phase 1) and the same schedule of RO5045337 treatment that they were receiving at the time of transitioning from their respective parent clinical study protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).

Participants will receive RO5045337 orally in doses ranging from 20 milligram per square meter (mg/m\^2) to 1800 mg/m\^2 daily, and up to 1500 mg dose twice daily on a variety of schedules including daily for up to 20 days and weekly dosing for 3 weeks in 28 day cycles until disease progression or unacceptable toxicity with maximum treatment duration of 24 months.

This open-label, extension study is designed to provide continuing treatment with RO5045337 to participants who have completed parent studies NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296). Participants are eligible to participate in this study if they have completed required Phase 1 study assessments for primary objectives of respective parent protocol and are having evidence of clinical benefit (as defined by the parent protocol). Participants will continue the most similar dose and formulation available (which does not exceed the maximum tolerated dose \[MTD\] or the maximum safely administered dose for that formulation during Phase 1) and the same schedule of RO5045337 treatment that they were receiving at the time of transitioning from the parent clinical study protocol.

An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies

A Multi-Center, Open-Label, Extension Study of RO5045337 (MDM2 Antagonist) Administered Orally in Patients Treated With RO5045337 on Previous Roche-Sponsored Phase 1 Cancer Studies

Spots Global Cancer Trial Database for ro5045337

Every month we try and update this database with for ro5045337 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery	NCT01143740	Sarcoma	RO5045337	18 Years -	Hoffmann-La Roche
A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma	NCT01605526	Sarcoma	RO5045337 doxorubicin	18 Years -	Hoffmann-La Roche
A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.	NCT00623870	Hematologic Neo...	RO5045337	18 Years -	Hoffmann-La Roche
A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery	NCT01143740	Sarcoma	RO5045337	18 Years -	Hoffmann-La Roche
An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies	NCT01677780	Myelogenous Leu...	RO5045337	18 Years -	Hoffmann-La Roche
An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies	NCT01677780	Myelogenous Leu...	RO5045337	18 Years -	Hoffmann-La Roche
A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.	NCT00623870	Hematologic Neo...	RO5045337	18 Years -	Hoffmann-La Roche

Spots Global Cancer Trial Database for ro5045337

Every month we try and update this database with for ro5045337 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 ro5045337 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.