Clinical trial · Interventional
Comparison of Biomarker Modulation by Inhibition of EGFR and/or SRC Family
Comparison of Biomarker Modulation by Inhibition of EGFR and/or Src Family Kinases Using Erlotinib and Dasatinib in Head and Neck Lung Cancers
NCT00779389CI-TRIAL-00020519completedPhase 1ClinicalTrials.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 central hypothesis to be tested in this study is that dual blockade of EGFR and Src pathways or proteins are distinct compared to inhibition of either kinase alone in head and neck and lung cancers.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib + Placebo | Drug | — | UNRESOLVED |
| Erlotinib | Drug | Erlotinib | ALIAS |
| Erlotinib plus Dasatinib | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Erlotinib 150 mg
- interventionNames
- Drug: Erlotinib
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Dasatinib + placebo
- interventionNames
- Drug: Dasatinib + Placebo
- type
- EXPERIMENTAL
- label
- Arm C
- description
- Erlotinib (150 mg) plus Dasatinib (100 mg) for 14-21 days.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically or cytologically confirmed, head and neck or lung cancers
* Any NSCLC histology is eligible. Stages I, II, IIIA (T3N1 only) or recurrent NSCLC that will be managed with surgery are eligible.
* Primary tumors of any head and neck (oral cavity, oropharynx, hypopharynx, or larynx) or lung site will be included.
* Surgical resection of head and neck or lung must be planned, either as primary treatment or salvage. Patients must have tissue available prior to receiving drug(s).
* Age greater then 18 years.
* ECOG performance status 0-2.
* Women of childbearing potential (WOCBP) must have:
1. A negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration
2. Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped.
3. Ability to take oral medication (dasatinib must be swallowed whole).
4. Concomitant Medications
* Patients agrees to discontinue St. Johns Wort while receiving dasatinib therapy (discontinue St. Johns Wort at least 5 days before starting dasatinib).
* Patient agrees that IV biphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
* Adequate hematologic, renal and hepatic function.
* Have signed written informed consent including a HIPPA form according to institutional guidelines.
Exclusion Criteria:
* Subjects who fail to meet the above criteria.
* Prior therapy for head and neck or lung cancers is allowed, with the exception of EGFR inhibitors. Any systemic therapy should have been completed at least 30 days prior to study enrollment.
* Pregnancy or breastfeeding. Women (patients or partners of male patients) of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy.
* Any unresolved chronic toxicity grade greater or equal to 2 from previous anticancer therapy (except alopecia and anemia).
* Acute hepatitis, known HIV, or active uncontrolled infection.
* Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment.
* Prior treatment with an EGFR inhibitor (tyrosine kinase inhibitor).
* Cardiac Symptoms; any of the following should be considered for exclusion:
1. History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (Coumadin). Patients whose therapy is changed to heparin is eligible.
2. History of any other cancer except basal cell carcinoma of the skin.
3. Concurrent medical condition which may increase the risk of toxicity, including:
\* Pleural or pericardial effusion of any grade
4. History of significant bleeding disorder unrelated to cancer, including:
* Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease).
* Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).
* Ongoing or recent (≤ 3 months) significant gastrointestinal bleeding.
5. Concomitant Medications, any of the following should be considered for exclusion:
\* Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
6. Women who:
* are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug,
* have a positive pregnancy test at baseline, or
* are pregnant or breastfeeding.
7. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.References
Publications (3)
- DERIVEDBauman JE, Duvvuri U, Gooding WE, Rath TJ, Gross ND, Song J, Jimeno A, Yarbrough WG, Johnson FM, Wang L, Chiosea S, Sen M, Kass J, Johnson JT, Ferris RL, Kim S, Hirsch FR, Ellison K, Flaherty JT, Mills GB, Grandis JR. Randomized, placebo-controlled window trial of EGFR, Src, or combined blockade in head and neck cancer. JCI Insight. 2017 Mar 23;2(6):e90449. doi: 10.1172/jci.insight.90449. PMID 28352657
- DERIVEDVan Allen EM, Lui VW, Egloff AM, Goetz EM, Li H, Johnson JT, Duvvuri U, Bauman JE, Stransky N, Zeng Y, Gilbert BR, Pendleton KP, Wang L, Chiosea S, Sougnez C, Wagle N, Zhang F, Du Y, Close D, Johnston PA, McKenna A, Carter SL, Golub TR, Getz G, Mills GB, Garraway LA, Grandis JR. Genomic Correlate of Exceptional Erlotinib Response in Head and Neck Squamous Cell Carcinoma. JAMA Oncol. 2015 May;1(2):238-44. doi: 10.1001/jamaoncol.2015.34. PMID 26181029
- DERIVEDGross ND, Bauman JE, Gooding WE, Denq W, Thomas SM, Wang L, Chiosea S, Hood BL, Flint MS, Sun M, Conrads TP, Ferris RL, Johnson JT, Kim S, Argiris A, Wirth L, Nikiforova MN, Siegfried JM, Grandis JR. Erlotinib, erlotinib-sulindac versus placebo: a randomized, double-blind, placebo-controlled window trial in operable head and neck cancer. Clin Cancer Res. 2014 Jun 15;20(12):3289-98. doi: 10.1158/1078-0432.CCR-13-3360. Epub 2014 Apr 11. PMID 24727329