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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00493155
First received: June 27, 2007
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This study will determine the maximum tolerated dose, and assess the safety, tol erability and pharmacokinetics of R1530 administered orally to patients with adv anced or metastatic solid tumors. R1530 will be administered daily for 14 days a t the starting dose; this dose will be escalated in subsequent cohorts of patien ts, after a satisfactory assessment of safety and tolerability of the previous d ose, until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression, and the target sample size is <100 indiv iduals.


Condition Intervention Phase
Neoplasms
Drug: RG1530
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "An Open-label, Multiple Ascending Dose Study to Determine the Maximum Tolerated Dose of R1530 in Patients With Advanced Solid Tumors."

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Plasma levels of R1530 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Tumor assessments [ Time Frame: Every 2 cycles of treatment ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: October 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RG1530
Administered po at escalating doses (10 cohorts)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493155

Locations
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02114-2696
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Nevada
Las Vegas, Nevada, United States, 89135
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00493155     History of Changes
Other Study ID Numbers: NO18674
Study First Received: June 27, 2007
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014