Clinical trial · Interventional
Study of Dovitinib and Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer
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
NCT01676714CI-TRIAL-00031140completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dovitinib | Drug | Dovitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dovitinib
- description
- 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.
- interventionNames
- Drug: Dovitinib
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Up to 100 months
- description
- 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.
Secondary outcomes (3)
- measure
- Disease Control Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.