Last updated: 11/07/2018 05:18:42
Hypertension and LFT elevations among Tyrosine Kinase inhibitor users
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Cohort study to document background rates of hypertension and Liver Function Test (LFT) elevations in users of Tyrosine Kinase inhibiting drugs-Varian Oncology Database
Trial description: A retrospective cohort study using the Varian Medical Oncology database will be performed to address these objectives. The primary objective of this project is to examine the background rates of hypertension and liver function test (LFT) abnormalities in cancer patients treated with tyrosine kinase inhibitors (TKIs). The secondary objective is to examine the rates of the following outcomes in this patient population: thromboembolic events (venous and arterial), hemorrhagic events, renal failure/renal insufficiency, adrenal insufficiency, hand and foot syndrome, hypothyroidism, mucositis, bowel perforation, and other lab abnormalities (pancreatic enzyme elevations, creatinine, and cytopenias).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Incidence rate of new onset hypertension among patients with normal BP at baseline. Hypertension defined as either systolic BP >150 mmHg or diastolic BP increases to >100 mmHg during follow-up.
Timeframe: The period from the index date (date of first TKI use) to the last visit before the database cut-off (July 31, 2008).
Secondary outcomes:
Incidence rate of elevated LFT among patients with normal LFT at baseline. Elevations defined at various upper limit of normal thresholds. Maximum elevation attained and proportion of patients returning to normal on and off TKI exposure also described.
Timeframe: The period from the index date (date of first TKI use) to the last visit before the database cut-off (July 31, 2008).
Incidence rates of thromboembolic events, hemorrhagic events, renal failure/renal insufficiency, adrenal insufficiency, hand and foot syndrome, hypothyroidism, mucositis, bowel perforation,pancreatic enzyme elevations, creatinine elevations, and cytopeni
Timeframe: The period from the index date (date of first TKI use) to the last visit before the database cut-off (July 31, 2008).
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Beth L. Nordstrom, PhD, MPH; Kathy H. Fraeman, SM; Weixiu Luo, MD, MS; Sumitra Shantakumar, PhD, Sarah H. Landis, PhD. Liver Function Test Abnormalities in Patients Treated with Small Molecule Tyrosine Kinase Inhibitors. International Society for Pharmacoepidemiology Annual Meeting, Brighton, UK, August 2010 (Abstract)
Landis S, Nordstrom B, Sansbury L, Shantakumar S, St. Lawrence S, Fraeman K, Nelson J. Tyrosine Kinase Inhibiting Drugs and Disruptions in Liver Function in an Oncology Setting: Comparisons of Two Population-based Databases . J Cancer Epidemiol. 2013;13(Article ID 358285):
Medical condition
Cancer, Neoplasms
Product
lapatinib
Collaborators
Not applicable
Study date(s)
October 2008 to February 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Adult patients (age ≥18 years) with any cancer diagnosed between January 1, 2000 and April 30, 2008 who have been treated with 1 one or more of the following TKI agents—erlotinib, gefitinib, dasatinib, imatinib, nilotinib, lapatinib, cetuximab, trastuzumab, or panitumumab.
- Patients with multiple primary cancer diagnoses will be excluded.
Inclusion and exclusion criteria
Inclusion criteria:
- Adult patients (age ≥18 years) with any cancer diagnosed between January 1, 2000 and April 30, 2008 who have been treated with 1 one or more of the following TKI agents—erlotinib, gefitinib, dasatinib, imatinib, nilotinib, lapatinib, cetuximab, trastuzumab, or panitumumab.
Exclusion criteria:
- Patients with multiple primary cancer diagnoses will be excluded.
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
Not applicable
Actual study completion date
2012-06-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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