A Study of IMGN901 for Patients With Advanced Solid Tumors and Extensive Stage Small Cell Lung Cancer

NCT01237678 | Terminated Phase 1 Results DMC

• 1 other identifier: Immunogen 0007
• Study Type: interventional
• Target: 181
• Locations: 4 countries
• Sites: 48

Brief Summary

The purpose of this study is to test safety and efficacy of this combination treatment (IMGN901, carboplatin and etoposide) in patients with solid tumors and extensive stage small cell lung cancer.

Conditions

Small Cell Lung Cancer

Keywords

Immunogen; Lung; Small Cell Lung Cancer; Carboplatin; ADC

Outcome Measures

Primary Outcomes (3)

• Occurrence of Dose Limiting Toxicities (DLT)

  The primary outcome measure for Phase I was 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. For the purposes of dose escalation and determination of MTD, DLTs were defined as AEs or abnormal laboratory values related to study treatment which occurred in Cycle 1 of the Dose Escalation phase, including any AEs that resulted in failure to meet the criteria for re-treatment. The following events were considered DLTs (using the most current version of CTCAE): febrile neutropenia; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding; ≥ Grade 3 peripheral neuropathy; ≥ Grade 3 vomiting, nausea, or diarrhea that persisted despite the use of optimal therapy; other ≥ grade 3 non-hematologic toxicity (with the exception of brief fatigue i.e. ≤ 72 hours and alopecia)

  21 days (Cycle 1)

• Progression Free Survival (PFS) in Phase II

  The primary outcome measure for Phase II was to determine the efficacy of IMGN901 in combination with carboplatin/etoposide chemotherapy as first-line treatment for patients with extensive stage small cell lung cancer. PFS was defined as the time from enrollment until objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. Only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented as the primary objective of this phase of the study was to compare PFS in the experimental arm (triplet combination) against historical PFS rates for carboplatin and etoposide. The control arm was planned primarily to reliably assess the safety of IMGN901 and to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed.

  From randomization to objective tumor progression or death (up to post-treatment follow-up 28 days after last dose, up to 22 months)

• Maximum Tolerated Dose (MTD) of IMGN901

  A primary outcome measure for Phase I was to determine the maximum tolerated dose (MTD) of IMGN901 when administered in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone in patients with solid tumors. The MTD was determined based on DLTs that occurred during Cycle 1.

  21 days (Cycle 1)

Secondary Outcomes (4)

• Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  From the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment (up to 22 months)

• Progression Free Survival (PFS) Rate at 6 Months

  6 months

• Median Overall Survival (OS) in Phase II

  From the time of enrollment until death on study due to any cause (up to post-treatment follow-up 28 days after last dose, up to 22 months)

• Overall Survival (OS) Rate at 12 Months

  12 months

Study Arms (2)

IMGN901 with carboplatin and etoposide

EXPERIMENTAL

Patients will receive IMGN901 along with carboplatin and etoposide for up to 6 cycles and then be able to continue on IMGN901 alone until no further benefit or toxicity.

Drug: IMGN901

Carboplatin and Etoposide

ACTIVE COMPARATOR

Patients will receive Carboplatin and etoposide for up to 6 cycles.

Drug: Carboplatin and Etoposide

Interventions

IMGN901 DRUG

Phase 2 regimen is IMGN901, Carboplatin, and Etoposide. IMGN901 to be given on days 1 and 8 every 21 days.

Also known as: BB-10901, Lorvotuzumab mertansine

IMGN901 with carboplatin and etoposide

Carboplatin and Etoposide DRUG

Patients assigned to Arm 2 were to receive carboplatin at the same AUC as utilized in Arm 1

Also known as: Toposar®, VePesid®, Etopophos®

Carboplatin and Etoposide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Pregnant or lactating females

Sponsors & Collaborators

• ImmunoGen, Inc.: lead

Study Sites (48)

Arizona Cancer Center @ UMC North

Tucson, Arizona, 85719, United States

Location

UCLA Oncology Center

Los Angeles, California, 90095, United States

Location

St. Joseph's Hospital

Orange, California, 92868, United States

Location

UCLA Hematology

Pasadena, California, 91105, United States

Location

UCLA Oncology Clinic

Santa Monica, California, 90404, United States

Location

UCLA Santa Clarita Valley Cancer Center

Valencia, California, 91355, United States

Location

UCLA Oncology Center

Westlake Village, California, 91361, United States

Location

Yale Medical Center

New Haven, Connecticut, 06510, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Holy Cross Hospital Bienes Comprehensive Cancer Center

Fort Lauderdale, Florida, 33308, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Johnson Therurer Cancer Center at Hackensack

Hackensack, New Jersey, 07601, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Oklahoma University

Oklahoma City, Oklahoma, 73104-5417, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

UPMC Cancer Centers East, Oxford Drive

Monroeville, Pennsylvania, 15146, United States

Location

UPMC Cancer Center St. Margaret

Pittsburgh, Pennsylvania, 15215, United States

Location

Univeristy of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC Cancer Center at UPMC Passavant (HOA)

Pittsburgh, Pennsylvania, 15237, United States

Location

South Carolina Oncology Associates

Columbia, South Carolina, 29210, United States

Location

University of Tennessee Medical Center Cancer Institute

Knoxville, Tennessee, 37920, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

UTHSC at San Antonio

San Antonio, Texas, 78229, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

Juravinski Cancer Center

Hamilton, Ontario, L8V 5C2, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

St. Mary's Hospital

Montreal, Quebec, H3T 1M5, Canada

Location

Royal Victoria

Montreal, Quebec, QC H3G, Canada

Location

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu y Sand Pau

Barcelona, 08041, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario

Madrid, 28222, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Royal Sussex Hospital

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

University College of London

London, England, NM12BU, United Kingdom

Location

The Christie Hospital

Withington, Manchester, M20 4BX, United Kingdom

Location

Royal Marsden

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Royal Marsden, London

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

lorvotuzumab mertansine; Carboplatin; Etoposide; etoposide phosphate

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Dr. Richard Bates, Sr. Manager, Publications
• Organization: ImmunoGen Inc.

Richard.Bates@immunogen.com

781 895 0196

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 18, 2018
• Results First Posted: January 18, 2018

Record last verified: 2017-12

Locations

CA (5); ES (6); US (32); GB (5)