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OpenTrials
Completed

NCT Number: NCT00400296

A Study of R547 in Patients With Advanced Solid Tumors.

This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is <100 individuals.

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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

Aurora, Colorado, United States

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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;
  • locally advanced or metastatic solid tumors;
  • measurable or evaluable disease.

Exclusion criteria

  • prior chemotherapy, radiotherapy or immunotherapy within 3 weeks of start of study;
  • prior history of CNS metastases with disease progression;
  • patients taking strong inhibitors and/or inducers of CYP3A4.

Treatment and study plan

RG547

Drug

Administered iv on days 1 and 8 of a 3 week cycle at escalating doses to successive groups of patients until MTD is reached.

Primary outcomes

  1. AEs, laboratory parameters.

    Time frame: Throughout study

Secondary outcomes

  1. Pharmacokinetic and pharmacodynamic profiles of R547

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Multiple Ascending Dose (MAD) Study of R547 Administered as an Intravenous Infusion on a Weekly Schedule in Patients With Advanced Solid Tumors

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 16, 2006
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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