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OpenTrials
Completed

NCT Number: NCT00559533

A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors

This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, 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. The anticipated time on study treatment is until disease progression or intolerable toxicity.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients, >=18 years of age;
  • solid tumor malignancies;
  • failed prior therapies, or no standard therapy available;
  • ECOG performance status of 0-2.

Exclusion criteria

  • patients receiving any other agent or therapy to treat their malignancy;
  • pre-existing gastrointestinal disorders which may interfere with absorption of drugs;
  • clinically significant cardiovascular disease.

Treatment and study plan

RO5045337

Drug

Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)

Primary outcomes

  1. MTD and associated dose schedule

    Time frame: Every 28 days

Secondary outcomes

  1. Clinical response

    Time frame: Event driven

  2. Dose-limiting toxicities.

    Time frame: Throughout study

  3. Pharmacokinetic profile

    Time frame: Throughout study

  4. Comparison safety and tolerability of daily versus twice daily dosing regimens

    Time frame: approximately 18 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Nov 16, 2007
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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