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

Neoplasms Clinical Trial

Official title:

"An Open-label, Multiple Ascending Dose Study to Determine the Maximum Tolerated Dose of R1530 in Patients With Advanced Solid Tumors."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493155
• Other study ID #: NO18674
• Status: Completed
• Phase: Phase 1
• First received: June 27, 2007
• Last updated: November 1, 2016
• Start date: October 2005
• Est. completion date: February 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• RG1530
Administered po at escalating doses (10 cohorts)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose		Throughout study	No
Secondary	AEs, laboratory parameters		Throughout study	No
Secondary	Plasma levels of R1530		Throughout study	No
Secondary	Tumor assessments		Every 2 cycles of treatment	No