Non-Small Cell Lung CancerPhase 2NCT01676714
Study of Dovitinib and Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer
A Phase 2 study testing Dovitinib in people with Non-Small Cell Lung Cancer and Colorectal Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to find out if dovitinib is an effective treatment for patients with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on anti-vascular endothelial growth factor (VEGF) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Colorectal Cancer
- What is being tested?
- Dovitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jun 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed non-small cell lung cancer or colorectal cancer for which no potentially curative treatment options are available
- Any number of prior treatment regimens are allowed
- Immediate prior treatment regimen must have included an anti-VEGF agent. Acceptable anti-VEGF therapy includes bevacizumab, sunitinib, or sorafenib. For other anti-VEGF therapies, contact the principal investigator.
- Last dose administered of bevacizumab must be at least 21-days but not more than 56-days from enrollment.
- Last dose of anti-VEGF tyrosine kinase inhibitor must be at least 7-days but not more than 56-days from enrollment.
- Willingness to consent to research biopsy
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- Measurable disease by RECIST 1.1 criteria
- Available tumor site amenable to core needle biopsy as determined by the treating investigator. Any questions regarding suitability of site for biopsy will be adjudicated by the principal investigator.
- Zubrod (ECOG) performance status 0 or 1
- Age ≥ 18 years old
- Patients who give a written informed consent
- Patients must have the following laboratory values:
- Platelets ≥ 100 x 109/L
- Absolute neutrophil count ≥ 1.5 x 109/L Hemoglobin > 9 g/dL
- Serum total bilirubin: ≤ 1.5 x upper limit of normal ULN
- ALT and AST ≤ 3.0 x ULN ( with or without liver metastases)
- Serum creatinine ≤ 1.5 x ULN or serum creatinine >1.5 - 3 x ULN
Who cannot join
- Patients with known brain metastases
- Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer
- Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies that have not resolved to NCI CTCAE grade 1 or less.
- Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study drug, or who have side effects that have not resolved to NCI CTCAE grade 1 or less.
- Patients who have received targeted therapy ≤ 1 week prior to starting study drug, or who have not recovered from the side effects of such therapy
- Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or ≤ 2 weeks prior to starting study drug in the case of localized radiotherapy or who have not recovered from radiotherapy toxicities
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- Patients who have undergone major surgery, open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
- Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
- Impaired cardiac function or clinically significant cardiac diseases
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib
- Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Known diagnosis of human immunodeficiency virus infection
- Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin
- Other concurrent severe and/or uncontrolled concomitant medical conditions
- Pregnant or breast-feeding women
- Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception.
- Fertile males not willing to use contraception, as stated above
- Patients unwilling or unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Comprehensive Cancer Center
Sacramento, California, 95817
About this study
Official title: Phase II Study of Dovitinib and Pilot Study of Fibroblast Growth Factor Receptor Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer Previously Treated With Anti-Vascular Endothelial Growth Factor Therapy
The purpose of this study is to find out if dovitinib is an effective treatment for patients with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on anti-vascular endothelial growth factor (VEGF) treatment.
Read the detailed description
The purposes of this study are 1) to evaluate the clinical efficacy of dovitinib and 2) to prospectively estimate the prevalence of fibroblast growth factor (FGF) signaling alterations in patients with advanced non-squamous non small cell lung cancer (NSCLC) or advanced CRC who have progressed on anti-VEGF treatment. Additionally, the investigators will make exploratory initial observations of the relationship between FGF signaling alterations and the clinical activity of dovitinib. This trial is expected to provide key biologic information that will inform the clinical development of dovitinib and provide initial evaluation of the analytic characteristics of these potential predictive biomarkers of its efficacy.
- Conditions
- Non-Small Cell Lung Cancer, Colorectal Cancer
- Being tested
- Dovitinib
- Keywords
- Dovitinib, Fibroblast Growth Factor Receptor Biomarkers, Anti-Vascular Endothelial Growth Factor Therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DovitinibDrug
Also called TK1258
| Study group | Role | What they receive |
|---|---|---|
| Dovitinib | Experimental | 500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops. Receives: Drug: Dovitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Up to 100 months
Secondary outcomes (3)
Disease Control Rate
The total number of patients who demonstrate a response to treatment. Measured by RECIST 1.1 criteria.
Measured: From start of treatment, up to 8 weeks
Progression Free Survival
The length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From start of treatment until the date of death from any cause, assessed up to 100 months
Number of Patients Who Experienced Treatment Related Toxicities
Toxicities will be summarized by the type, severity (by NCI CTCAE), time of onset, duration, and outcome. Toxicity will be graded according to the NCI CTCAE version 4.0.
Measured: Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startFeb 2013
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Thomas Semrad, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676714
- Sponsor's protocol ID
- UCDCC#231
- Other IDs
- 344991, CTKI258AUS21T
- Status last verified
- Jan 2018
- First submitted
- 27 Aug 2012
- Last updated
- 10 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Dovitinib and Pilot Study of Fibroblast Growth Factor Receptor Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer Previously Treated With Anti-Vascular Endothelial Growth Factor Therapy
- ClinicalTrials.gov ID
- NCT01676714
- Acronym / sponsor ID
- UCDCC#231
- Conditions
- Non-Small Cell Lung Cancer, Colorectal Cancer
- Keywords
- Dovitinib, Fibroblast Growth Factor Receptor Biomarkers, Anti-Vascular Endothelial Growth Factor Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Feb 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if dovitinib is an effective treatment for patients with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on anti-vascular endothelial growth factor (VEGF) treatment.
Detailed description
The purposes of this study are 1) to evaluate the clinical efficacy of dovitinib and 2) to prospectively estimate the prevalence of fibroblast growth factor (FGF) signaling alterations in patients with advanced non-squamous non small cell lung cancer (NSCLC) or advanced CRC who have progressed on anti-VEGF treatment. Additionally, the investigators will make exploratory initial observations of the relationship between FGF signaling alterations and the clinical activity of dovitinib. This trial is expected to provide key biologic information that will inform the clinical development of dovitinib and provide initial evaluation of the analytic characteristics of these potential predictive biomarkers of its efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dovitinib | Experimental | Drug: Dovitinib500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed non-small cell lung cancer or colorectal cancer for which no potentially curative treatment options are available
- Any number of prior treatment regimens are allowed
- Immediate prior treatment regimen must have included an anti-VEGF agent. Acceptable anti-VEGF therapy includes bevacizumab, sunitinib, or sorafenib. For other anti-VEGF therapies, contact the principal investigator.
- Last dose administered of bevacizumab must be at least 21-days but not more than 56-days from enrollment.
- Last dose of anti-VEGF tyrosine kinase inhibitor must be at least 7-days but not more than 56-days from enrollment.
Key exclusion criteria (18 listed)
- Patients with known brain metastases
- Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer
- Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies that have not resolved to NCI CTCAE grade 1 or less.
- Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study drug, or who have side effects that have not resolved to NCI CTCAE grade 1 or less.
- Patients who have received targeted therapy ≤ 1 week prior to starting study drug, or who have not recovered from the side effects of such therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DovitinibAlso: TK1258 | Drug | Dovitinib |
Primary outcome
Overall Response Rate
Time frame: Up to 100 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
3 secondary outcomes
Disease Control Rate
Time frame: From start of treatment, up to 8 weeks
Progression Free Survival
Time frame: From start of treatment until the date of death from any cause, assessed up to 100 months
Number of Patients Who Experienced Treatment Related Toxicities
Time frame: Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Semrad, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dovitinib in people with Non-Small Cell Lung Cancer and Colorectal Cancer, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.