Last updated: 11/07/2018 17:38:16
A Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally Daily to Subjects With Solid Tumors
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally Daily to Subjects with Solid Tumors
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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
Timeframe: 2 years
Secondary outcomes:
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
Timeframe: 1 year
Interventions:
Enrollment:
37
Primary completion date:
2009-02-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Shapiro, McCallum, Adams, Sherman, Weller, Swann, Keer, Miles, Mueller, LoRusso. A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of Once Daily Oral Foretinib, a Multikinase Inhibitor, in Subjects with Solid Tumors. Invest New Drugs. 2013;31(3):742-50
Medical condition
Solid Tumours
Product
foretinib
Collaborators
Not applicable
Study date(s)
August 2006 to November 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Histologically confirmed solid tumor which is metastatic or unresectable with no known effective treatment measures,
- ECOG performance status of </= 2.
- Anticancer therapy within 30 days of the start of treatment,
- Received radiation to =25% of bone marrow within 30 days of treatment.
Inclusion and exclusion criteria
Inclusion criteria:
- Histologically confirmed solid tumor which is metastatic or unresectable with no known effective treatment measures,
- ECOG performance status of
- 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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2009-02-05
Actual study completion date
2009-09-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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