NCT00493155

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2005

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

June 27, 2007

Last Update Submit

November 1, 2016

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

    Throughout study

Secondary Outcomes (3)

  • AEs, laboratory parameters

    Throughout study

  • Plasma levels of R1530

    Throughout study

  • Tumor assessments

    Every 2 cycles of treatment

Study Arms (1)

1

EXPERIMENTAL
Drug: RG1530

Interventions

RG1530DRUG

Administered po at escalating doses (10 cohorts)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Boston, Massachusetts, 02114-2696, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

Las Vegas, Nevada, 89135, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

October 1, 2005

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(6)