E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
This study is currently recruiting participants.
Verified February 2013 by Eisai Inc.
Sponsor:
Eisai Inc.
Collaborator:
PharmaBio Development Inc.
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01332266
First received: April 7, 2011
Last updated: February 22, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to determine whether patients with Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck who receive either E7050 administered with Cetuximab or Cetuximab alone experience greater benefit
| Condition | Intervention | Phase |
|---|---|---|
|
Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck |
Drug: E7050 Drug: Cetuximab |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck |
Resource links provided by NLM:
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Safety Parameters- Adverse Events [ Time Frame: until study termination; 3 years ] [ Designated as safety issue: Yes ]
- Phase Ib: to determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with cetuximab in patients with platinum-resistant, recurrent and/or metastatic squamous cell carcinoma for the head and neck (SCCHN);
- Phase II: to evaluate the safety and tolerability of E7050 administered in combination with cetuximab compared with cetuximab alone in patients with platinum-resistant, recurrent and/or metastatic SCCHN.
- Safety Parameter- concomitant medications [ Time Frame: until study termination; 3 years ] [ Designated as safety issue: Yes ]
- Phase Ib: to determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with cetuximab in patients with platinum-resistant, recurrent and/or metastatic squamous cell carcinoma for the head and neck (SCCHN);
- Phase II: to evaluate the safety and tolerability of E7050 administered in combination with cetuximab compared with cetuximab alone in patients with platinum-resistant, recurrent and/or metastatic SCCHN.
- Safety Parameter- Lab tests [ Time Frame: Day 1 and every 28 days until study termination; 3 years ] [ Designated as safety issue: Yes ]
- Phase Ib: to determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with cetuximab in patients with platinum-resistant, recurrent and/or metastatic squamous cell carcinoma for the head and neck (SCCHN);
- Phase II: to evaluate the safety and tolerability of E7050 administered in combination with cetuximab compared with cetuximab alone in patients with platinum-resistant, recurrent and/or metastatic SCCHN.
- Safety Parameter- ECGs [ Time Frame: Screening and 28 days after end of therapy; 3 years ] [ Designated as safety issue: Yes ]
- Phase Ib: to determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with cetuximab in patients with platinum-resistant, recurrent and/or metastatic squamous cell carcinoma for the head and neck (SCCHN);
- Phase II: to evaluate the safety and tolerability of E7050 administered in combination with cetuximab compared with cetuximab alone in patients with platinum-resistant, recurrent and/or metastatic SCCHN.
Secondary Outcome Measures:
- Efficacy Parameter [ Time Frame: • Time Frame: Time to progression (TTP) - until the date of first documented progression of such patient's disease or death for 3 years ] [ Designated as safety issue: No ]
Phase Ib: To determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with cetuximab in patients with platinum-resistant, recurrent and/or metastatic SCCHN;
Phase II: To evaluate the safety and tolerability of E7050 when administered in combination with cetuximab as compared with cetuximab alone in patients with platinum-resistant, recurrent and/or metastatic SCCHN..
- Efficacy Parameter [ Time Frame: Overall survival (OS) - until the date of first documented progression of such patient's disease or death for 3 years ] [ Designated as safety issue: No ]
Phase Ib: To determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with cetuximab in patients with platinum-resistant, recurrent and/or metastatic SCCHN;
Phase II: To evaluate the safety and tolerability of E7050 when administered in combination with cetuximab as compared with cetuximab alone in patients with platinum-resistant, recurrent and/or metastatic SCCHN.
- Efficacy Parameter [ Time Frame: Overall response rate (ORR) - until the date of first documented progression of such patient's disease or death for 3 years ] [ Designated as safety issue: No ]
Phase Ib: To determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with cetuximab in patients with platinum-resistant, recurrent and/or metastatic SCCHN;
Phase II: To evaluate the safety and tolerability of E7050 when administered in combination with cetuximab as compared with cetuximab alone in patients with platinum-resistant, recurrent and/or metastatic SCCHN.
| Estimated Enrollment: | 95 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Active Comparator; Phase IB: Cohort 1,2,and 3
Phase Ib: Cohort 1; 200 mg E7050 + 250 mg/m2 cetuximab Cohort 2; 300 mg E7050 + 250 mg/m2 cetuximab Cohort 3; 400mg E7050 + 250mg/m2 cetuximab Phase II: Arm 1; MTD E7050 + 250 mg cetuximab Arm 2; 250 mg cetuximab Interventions: Drug cetuximab |
Drug: E7050
E7050 given orally at 200, 300, or 400 mg once daily.
Drug: Cetuximab
Cetuximab is given at an initial dose of 400 mg/m2 given as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a dose of 250 mg/m2 given as a 1-hour IV infusion on Day 8, Day 15, and Day 22 of Cycle 1, and Day 1, Day 8, Day 15, and Day 22 of each subsequent cycle.
|
|
Active Comparator: Phase II
Phase II: Arm 1; MTD E7050 + 250 mg/m2 cetuximab Arm 2; 250 mg/m2 cetuximab |
Drug: E7050
E7050 given orally at 200, 300, or 400 mg once daily.
Drug: Cetuximab
Cetuximab is given at an initial dose of 400 mg/m2 given as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a dose of 250 mg/m2 given as a 1-hour IV infusion on Day 8, Day 15, and Day 22 of Cycle 1, and Day 1, Day 8, Day 15, and Day 22 of each subsequent cycle.
|
Detailed Description:
This open-label, multicenter, randomized study will consist of a Phase Ib: a safety run-in period with 3 ascending doses of E7050 in combination with Cetuximab; and a Phase II portion: a randomized 2-arm period. Approximately 95 patients with Platinum-Resistant Squamous Cell Carcinoma of the head and neck will be enrolled in the study (10-15 patients in the Phase Ib portion and 80 patients in the Phase II portion). Patients will only participate in either the Phase Ib or the Phase II portion of the study.
In the phase II portion, Patients will receive study treatment (E7050 plus Cetuximab or Cetuximab alone) for approximately six 28-day cycles (24 weeks). Beyond 24 weeks, patients who are experiencing clinical benefit may continue E7050 plus cetuximab, cetuximab alone or E7050 alone (Arm 1), or may continue cetuximab alone (Arm 2), depending on the original randomization treatment arm, for as long as clinical benefit is sustained and the treatment is well tolerated.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Platinum-resistant (defined as failure to respond to treatment with a platinum agent or recurrence of disease after initial response to platinum within 12 months of completing therapy), locally advanced, recurrent and/or metastatic SCCHN, which is untreatable by surgical resection or radiation therapy;
- ECOG PS of 0-2;
- Blood pressure must be well-controlled. Patients must have no history of hypertensive crisis or hypertensive encephalopathy; Adequate end organ function
Exclusion Criteria
- Nasopharyngeal tumors;
- Previously received E7050, anti-cmet, anti-angiogenic therapy, or anti-EGFR therapy (prior anti-angiogenic/EGFR therapy is permitted in Phase Ib only. Prior cetuximab is permitted if administered in combination with radiation;
- Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
- Palliative radiotherapy is not permitted throughout the study period;
- Clinically significant hemoptysis;
- Serious non-healing wound, ulcer, or active bone fracture;
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for a major surgical procedure during the course of the study;
- Clinically significant gastrointestinal bleeding within 6 months prior to first dose.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332266
Locations
| United States, Arizona | |
| Arizona Oncology Associates, PC - CASA | Recruiting |
| Tucson, Arizona, United States, 85715 | |
| Contact: Nina Davis 520-290-2510 ndavis@acresearch.com | |
| Contact: Carmen King 520-290-2510 cking@acresearch.com | |
| Principal Investigator: Manuel Modiano | |
| United States, Florida | |
| Florida Cancer Specialists - Colonial | Active, not recruiting |
| Fort Myers, Florida, United States, 33905 | |
| Florida Cancer Specialists | Not yet recruiting |
| St. Petersburg, Florida, United States, 33705 | |
| Contact: Christine Biermeier 727-216-1143 cbiermeier@flcancer.com | |
| Principal Investigator: Joseph Mace | |
| United States, Massachusetts | |
| Tufts University School of Medicine | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Elizabeth Grimm 617-636-8501 egrimm@tuftsmedicalcenter.org | |
| Principal Investigator: Pamela Smith | |
| United States, Missouri | |
| Washington University | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: William Chapman 314-362-6904 kjwillia1@dom.wustl.edu | |
| Contact: Jessica Ley (314) 362-6904 jley@dom.wustl.edu | |
| Principal Investigator: Douglas Adkins | |
| United States, Ohio | |
| Mercy Cancer Center at St. Anne | Recruiting |
| Toledo, Ohio, United States, 43623 | |
| Contact: Molly McCormick, MD 419-251-4919 molly_mccormick@mhsnr.org | |
| Principal Investigator: Nasfat Shehadeh, MD | |
| United States, Oklahoma | |
| Peggy & Charles Stephenson Oklahoma Cancer Ctr | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Toni Davis 405-271-4022 toni-davis@ouhsc.edu | |
| Contact: Kelsey Williams (405) 271-4022 kelsey-williams@ouhsc.edu | |
| Principal Investigator: Carla Kurkijan | |
| United States, Tennessee | |
| Tennessee Oncology | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Gina Courtney 615-329-7274 gina.courtney@scresearch.net | |
| Contact: John Snyder (615) 329-7274 john.snyder@scresearch.net | |
| Principal Investigator: David Spigel | |
| United States, Washington | |
| Medical Oncology Associates, P.S. | Recruiting |
| Spokane, Washington, United States, 99208 | |
| Contact: Vicki Townsend 509-462-2273 townsendv@nwrm.com | |
| Contact: Monika Chaudhry 509-462-2273 chaudhrym@nwrm.com | |
| Principal Investigator: Arvind Chaudhry | |
| Korea, Republic of | |
| Chonnam National University Hwasun Hospital | Recruiting |
| Hwasun-gun, Jeollanam, Korea, Republic of, 519-763 | |
| Contact: Ji Hyun Moon +82 61 379 7632 moonjh1207@daum.net | |
| Contact: Se Min Na +82 61 379 7632 9835@naver.com | |
| Principal Investigator: Ik Joo Chung | |
| Pusan National University Hospital | Recruiting |
| Busan, Korea, Republic of, 602-739 | |
| Contact: Ok ran Ryu angelhood98@naver.com | |
| Principal Investigator: Young Jin Choi | |
| National Cancer Center | Recruiting |
| Goyang-si Gyeonggi-do, Korea, Republic of, 410-769 | |
| Contact: HyunJu Kim +82 31 920 1621 aspirite@hanmail.net | |
| Contact: SanEun Lee +82 31 920 1621 piaspia@ncc.re.kr | |
| Principal Investigator: Tak Yun | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Elisabet Kim 82230103217 florence@amc.seoul.kr | |
| Contact: Soo-Yeon Park 82230103217 shyunpk@amc.seoul.kr | |
| Principal Investigator: Sung-Bae Kim | |
| Severence Hospital, Yonsei University Health System | Recruiting |
| Seoul, Korea, Republic of, 123-752 | |
| Contact: Ji yeon Lee +82 2 2228 8126 mjjo@yuhs.ac | |
| Principal Investigator: Byoung Chul Cho | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Heekyoung Koo +82 2 2072 0832 kooheekyoung@gmail.com | |
| Principal Investigator: Se-Hoon Lee | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Jeeyoon Kim +82 2 3410 3438 jyoon55.kim@samsung.com | |
| Contact: Enumi Seo +82 2 3410 3438 eunmika.se@samsung.com | |
| Principal Investigator: Myung-Ju Ahn | |
| Ukraine | |
| SI Dnipropetrovsk Medical Academy of MOHU | Recruiting |
| Dnipropetrovsk, Ukraine, 49102 | |
| Contact: Igor Bondarenko 380562585372 oncology@dsma.dp.ua | |
| Principal Investigator: Igor Bondarenko | |
| Don.SMU Ch.of Hosp.Ther.o.t bas.of Instit.of Urg.& Rec. Surg. | Recruiting |
| Donetsk, Ukraine, 83099 | |
| Contact: Svitlana Dolzhenko 380623127257 s_dolzhenko@mail.ru | |
| Principal Investigator: Oleg Malyeyev | |
| Municipal Clinical Medical and Prophylactic Institution Donetsk Regional Antitumor Centre | Recruiting |
| Donetsk, Ukraine, 83092 | |
| Contact: Stanislav Zolotukhin 380622236693 atanislaw.zolotukhin@gmail.com | |
| Principal Investigator: Stanislav Zolotukhin | |
| SE S.P. Grygoriev Institute of Medical Radiology of AMS U | Recruiting |
| Kharkiv, Ukraine, 61024 | |
| Contact: Oksana Tarasova 380577041414 oksana-tarasova-@mail.ru | |
| Principal Investigator: Oksana Tarasova | |
| St.In.,Inst.of Otolaryngology,n.a.O.S.Kolomyychenko of AMSU | Not yet recruiting |
| Kyiv, Ukraine, 3057 | |
| Contact: Irina Zarytska 380444831539 zirina2@bigmir.net | |
| Principal Investigator: Dmytro Zabolotnyi | |
| RMI Sumy Regional Clinical Oncological Dispensary | Not yet recruiting |
| Sumy, Ukraine, 40005 | |
| Contact: Oleksandr Vynnychenko 380542781306 vynnychenkool@ukr.net | |
| Principal Investigator: Ihor Vynnychenko | |
| SHEE Uzhgorod NU Ch.of Rad Diagnost Meth,Clin Oncol,Anesthes,Inten Care & Emerg Med of PE Faculty | Recruiting |
| Uzhgorod, Ukraine, 88000 | |
| Contact: Yevgeniy Hotko 380312642145 yhotko@gmail.com | |
| Principal Investigator: Yevgeniy Hotko | |
| United Kingdom | |
| UCL Cancer Institute | Recruiting |
| London, Greater London, United Kingdom, NW1 2BU | |
| Contact: Martin Forster 448451555000 martin.forster@cancer.ucl.ac.uk | |
| Principal Investigator: Martin Forster | |
| The Christie NHS Foundation Trust | Recruiting |
| Manchester, Greater Manchester, United Kingdom, M20 4BX | |
| Contact: Andrew Sykes 441614463000 andrew.sykes@christie.nhs.uk | |
| Principal Investigator: Andrew Sykes | |
| Beatson West of Scotland Cancer Centre | Not yet recruiting |
| Glasgow, Strathclyde, United Kingdom, G12 0YN | |
| Contact: Claire Paterson 441413017068 claire.paterson2@ggc.scot.nhs.uk | |
| Principal Investigator: Claire Paterson | |
Sponsors and Collaborators
Eisai Inc.
PharmaBio Development Inc.
Investigators
| Study Director: | Melissa J Versola, RN | Innovation Quintiles |
More Information
No publications provided
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01332266 History of Changes |
| Other Study ID Numbers: | E7050-702, 2011-000773-31 |
| Study First Received: | April 7, 2011 |
| Last Updated: | February 22, 2013 |
| Health Authority: | United States: Food and Drug Administration Ukraine: Ministry of Health |
Keywords provided by Eisai Inc.:
|
Cancer, head and neck, squamous cell carcinoma of the head and neck, phase I, phase II |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Neoplasms by Site Cetuximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013