A Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally Daily to Subjects With Solid Tumors

July 24, 2017 updated by: GlaxoSmithKline

A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally Daily to Subjects With Solid Tumors

This clinical study is being conducted at two sites to determine the optimum dose, safety, and tolerability of oral daily GSK1363089 treatment in adults with solid tumors. This study is no longer recruiting subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed solid tumor which is metastatic or unresectable with no known effective treatment measures,
  • ECOG performance status of </= 2.
  • Adequate bone marrow reserve, hepatic, renal, and cardiovascular function,
  • Negative pregnancy test.

Exclusion Criteria:

  • Anticancer therapy within 30 days of the start of treatment,
  • Received radiation to =25% of bone marrow within 30 days of treatment.
  • Known brain metastasis,
  • Uncontrolled intercurrent illness,
  • HIV positive,
  • Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Cohort 1 will include 60 milligram (mg) of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.
Drug: GSK1363089 (formerly XL880)
GSK1363089 will be available as solid capsules with dose unit of 20, 100 and 200 mg. Subjects will administer GSK1363089 capsules orally
Experimental: Cohort 2
Cohort 2 will include 120 mg of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.
Drug: GSK1363089 (formerly XL880)
GSK1363089 will be available as solid capsules with dose unit of 20, 100 and 200 mg. Subjects will administer GSK1363089 capsules orally
Experimental: Cohort 3
Cohort 3 will include 240 mg of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.
Drug: GSK1363089 (formerly XL880)
GSK1363089 will be available as solid capsules with dose unit of 20, 100 and 200 mg. Subjects will administer GSK1363089 capsules orally
Experimental: Cohort 4
Cohort 4 will include 480 mg of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.
Drug: GSK1363089 (formerly XL880)
GSK1363089 will be available as solid capsules with dose unit of 20, 100 and 200 mg. Subjects will administer GSK1363089 capsules orally
Experimental: Cohort 5
Cohort 5 will include 960 mg of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.
Drug: GSK1363089 (formerly XL880)
GSK1363089 will be available as solid capsules with dose unit of 20, 100 and 200 mg. Subjects will administer GSK1363089 capsules orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of daily oral administration of GSK1363089 in subjects with solid tumors
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma pharmacokinetics (PK) of daily GSK1363089 in subjects with solid tumors, pharmacodynamic effects of daily GSK1363089, Long-term safety and tolerability of daily GSK1363089, Tumor response after daily administration of GSK1363089
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2006

Primary Completion (Actual)

May 2, 2009

Study Completion (Actual)

November 9, 2009

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MET111648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Dataset Specification
    Information identifier: MET111648
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: MET111648
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: MET111648
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: MET111648
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: MET111648
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: MET111648
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: MET111648
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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