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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00493155
Recruitment Status : Completed
First Posted : June 28, 2007
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: RG1530 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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."
Study Start Date : October 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Experimental: 1 Drug: RG1530
Administered po at escalating doses (10 cohorts)

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. AEs, laboratory parameters [ Time Frame: Throughout study ]
  2. Plasma levels of R1530 [ Time Frame: Throughout study ]
  3. Tumor assessments [ Time Frame: Every 2 cycles of treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00493155

United States, Massachusetts
Boston, Massachusetts, United States, 02114-2696
Boston, Massachusetts, United States, 02115
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
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00493155     History of Changes
Other Study ID Numbers: NO18674
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016