Last updated: 11/04/2018 09:13:38
A Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally 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 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 GSK1363089 treatment in adults with solid tumors. This study is no longer recruiting subjects.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of GSK1363089 administered orally (up to twelve different doses) to subjects with solid tumors
Timeframe: 3 years
Secondary outcomes:
To evaluate pharmacokinetic (PK) and pharmacodynamic parameters of GSK1363089, radiographically evaluate the effects of GSK1363089 on tumors, evaluate tumor response after repeat administration of GSK1363089
Timeframe: 1 year
Interventions:
Enrollment:
40
Primary completion date:
2008-13-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Eder JP, Shapiro GI, Appleman LJ, Zhu AX, Miles D, Keer H, Cancilla B, Chu F, Hitchcock-Bryan S, Sherman L, Heath EI, Boerner SA, LoRusso PM. A Phase I Study of Foretinib, a Multi-Targeted Inhibitor of c-Met and Vascular Endothelial Growth Factor Receptor 2. [Clin Cancer Res]. 2010;16(13):3507-3516.
Medical condition
Solid Tumours
Product
foretinib
Collaborators
Not applicable
Study date(s)
March 2005 to August 2011
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.
- Chemotherapy within 4-6 weeks of the start of treatment,
- Radiotherapy within 4 weeks of the start 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:
- Chemotherapy within 4-6 weeks of the start of treatment,
- Radiotherapy within 4 weeks of the start of treatment,
- Known brain metastasis,
- Uncontrolled medical disorder such as infection or cardiovascular disease,
- 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
2008-13-05
Actual study completion date
2011-29-08
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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