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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety Parameters- Adverse Events

Outcome Description:

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.

Outcome Time Frame:

until study termination; 3 years

Safety Issue:

Yes

Principal Investigator

Melissa J Versola, RN

Investigator Role:

Study Director

Investigator Affiliation:

Innovation Quintiles

Authority:

United States: Food and Drug Administration

Study ID:

E7050-702

NCT ID:

NCT01332266

Start Date:

May 2011

Completion Date:

October 2014

Related Keywords:

  • Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
  • Cancer, head and neck, squamous cell carcinoma of the head and neck, phase I, phase II
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Tufts University School of MedicineBoston, Massachusetts  02111
Florida Cancer SpecialistsFort Myers, Florida  33901
Washington UniversitySt. Louis, Missouri  63110
Tennessee OncologyNashville, Tennessee  37203
Peggy & Charles Stephenson Oklahoma Cancer CtrOklahoma City, Oklahoma  73104
Arizona Oncology Associates, PC - CASATucson, Arizona  85715
Florida Cancer Specialists - ColonialFort Myers, Florida  33905
Mercy Cancer Center at St. AnneToledo, Ohio  43623
Medical Oncology Associates, P.S.Spokane, Washington  99208