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

NCT ID: NCT00493155

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

RG1530

Intervention Type DRUG

Administered po at escalating doses (10 cohorts)

Interventions

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RG1530

Administered po at escalating doses (10 cohorts)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Boston, Massachusetts, United States

Site Status

Boston, Massachusetts, United States

Site Status

Boston, Massachusetts, United States

Site Status

Detroit, Michigan, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NO18674

Identifier Type: -

Identifier Source: org_study_id