NCT00400296

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2005

Typical duration for phase_1

Geographic Reach
1 country

4 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

May 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.5 years

First QC Date

November 15, 2006

Last Update Submit

November 1, 2016

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • AEs, laboratory parameters.

    Throughout study

Secondary Outcomes (1)

  • Pharmacokinetic and pharmacodynamic profiles of R547

    Throughout study

Study Arms (1)

1

EXPERIMENTAL
Drug: RG547

Interventions

RG547DRUG

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

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;
  • locally advanced or metastatic solid tumors;
  • measurable or evaluable disease.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

New Brunswick, New Jersey, 08901, United States

Location

Unknown Facility

Charlotte, North Carolina, 28203, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.

    PMID: 19238148DERIVED

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

November 15, 2006

First Posted

November 16, 2006

Study Start

May 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(4)