A Multiple Ascending Dose Study of R1530 in Patients With Advanced Solid Tumors.

Hoffmann-La Roche48 enrolled

Overview

This study will determine the maximum tolerated dose, and assess the safety, tolerability and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid tumors. R1530 will be administered daily for 14 days at the starting dose; this dose will be escalated in subsequent cohorts of patients, after a satisfactory assessment of safety and tolerability of the previous dose, until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

RG1530DRUG

Administered po at escalating doses (10 cohorts)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients, \>=18 years of age; * cancer not amenable to curative treatment (ie advanced and/or metastatic); * measurable or evaluable disease; * adequate cardiac, hepatic and renal function. Exclusion Criteria: * patients with known CNS metastases; * serious cardiovascular illness or other medical conditions; * prior chemotherapy, radiotherapy or immunotherapy within 28 days of start of treatment , or hormone therapy within 14 days of start of treatment; * inability to swallow oral medications, or impaired gastrointestinal absorption.

Locations (6)

Unnamed facility

Boston, Massachusetts, United States

Unnamed facility

Boston, Massachusetts, United States

Unnamed facility

Boston, Massachusetts, United States

Unnamed facility

Detroit, Michigan, United States

Outcomes

Primary Outcomes

Maximum tolerated dose

Time frame: Throughout study

Secondary Outcomes

AEs, laboratory parameters

Time frame: Throughout study

Plasma levels of R1530

Time frame: Throughout study

Tumor assessments

Time frame: Every 2 cycles of treatment

Data from ClinicalTrials.gov

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