A Study of R547 in Patients With Advanced Solid Tumors.

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400296
• Other study ID #: NP18378
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2006
• Last updated: November 1, 2016
• Start date: May 2005
• Est. completion date: November 2008

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• RG547
Administered iv on days 1 and 8 of a 3 week cycle at escalating doses to successive groups of patients until MTD is reached.

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	AEs, laboratory parameters.		Throughout study	No
Secondary	Pharmacokinetic and pharmacodynamic profiles of R547		Throughout study	No