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A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine in Combination With Carboplatin/Etoposide in Patients With Advanced Solid Tumors Including Extensive Stage Small Cell Lung Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer

Thank you

Trial Information

A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine in Combination With Carboplatin/Etoposide in Patients With Advanced Solid Tumors Including Extensive Stage Small Cell Lung Cancer


Inclusion Criteria:



- Patients must be 18 years old

- Patients must have been diagnosed with small-cell lung cancer (SCLC) and extensive
disease

- ECOG performance status of 0, 1, or 2

- No prior systemic chemotherapy for the treatment of SCLC

Exclusion Criteria:

- Pregnant or lactating females

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:

Occurrence of Dose Limiting Toxicities (DLT)

Outcome Description:

Phase 1: to determine the maximum tolerated dose (MTD) and characterize the dose limiting toxicities (DLT) of IMGN901 when administered in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone in patients with solid tumors. Phase 2: to determine the efficacy of IMGN901 in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone versus carboplatin/etoposide chemotherapy as first-line treatment for patients with extensive stage small cell lung cancer.

Outcome Time Frame:

30 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

Immunogen 0007

NCT ID:

NCT01237678

Start Date:

November 2010

Completion Date:

July 2015

Related Keywords:

  • Small Cell Lung Cancer
  • Immunogen
  • Lung
  • Small Cell Lung Cancer
  • Carboplatin
  • ADC
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
University Hospitals of ClevelandCleveland, Ohio  44106
Sibley Memorial HospitalWashington, District of Columbia  20016
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Anne Arundel Medical CenterAnnapolis, Maryland  21401
Greater Baltimore Medical CenterBaltimore, Maryland  21204
South Carolina Oncology AssociatesColumbia, South Carolina  29201
University of FloridaGainesville, Florida  32610-0277
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Oregon Health and Science UniversityPortland, Oregon  97201
Northwest Medical SpecialtiesTacoma, Washington  98405
Sarah Cannon Research InstituteNashville, Tennessee  37203
Oklahoma UniversityTulsa, Oklahoma  74104
UCLA Oncology CenterLos Angeles, California  90095
St. Joseph's HospitalOrange, California  92868
Arizona Cancer Center @ UMC NorthTucson, Arizona  85719
Holy Cross Hospital Bienes Comprehensive Cancer CenterFort Lauderdale, Florida  33308
Johnson Therurer Cancer Center at HackensackHackensack, New Jersey  07601
UTHSC at San AntonioSan Antonio, Texas  78229
UCLA HematologyPasadena, California  91105
UCLA Oncology ClinicSanta Monica, California  90404
UCLA Santa Clarita Valley Cancer CenterValencia, California  91355
Yale Medical CenterNew Haven, Connecticut  06510
Bayview Medical CenterBaltimore, Maryland  21224
UPMC Cancer Centers East, Oxford DriveMonroeville, Pennsylvania  15146
UPMC Cancer Center at UPMC Passavant (HOA)Pittsburg, Pennsylvania  15237
UPMC Cancer Center St. MargaretPittsburg, Pennsylvania  15215
Univeristy of Pittsburg Medical CenterPittsburgh, Pennsylvania  15232
University of Tennessee Medical Center Cancer InstituteKnoxville, Tennessee  37920