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First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors (IMGN-0401)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT01609556
First received: May 30, 2012
Last updated: October 12, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to test IMGN853 in patients with FOLR-1 positive tumors.

Condition Intervention Phase
FOLR-1 Positive Solid Tumors
Drug: IMGN853
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • Determine Maximum Tolerated Dose and Recommended Phase 2 Dose of IMGN853 [ Time Frame: During study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the safety and tolerability of IMGN853 [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetics of IMGN853 [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Assess IMGN853 pharmacodynamic activity [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Characterize the immunogenicity of IMGN853 [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Describe any preliminary evidence of IMGN853 antitumor activity [ Time Frame: During the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 205
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMGN853 Drug: IMGN853
Dose escalation study. Dosing on day 1 of every 21 day cycle.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Criteria for Selection of Patient Population Inclusion Criteria

  • Patients with advanced solid tumor that is refractory to standard treatment, for which no standard treatment is available, or the patient refuses standard therapy.
  • ≥ 18 years old at the time of informed consent.
  • ECOG Performance Status 0 or 1.
  • Patients must have adequate hematologic and organ function.
  • Patients must be willing and able to sign the informed consent form, and to follow the study visit schedule and other protocol requirements.
  • Women of childbearing potential and men must agree to use effective contraceptive methods while on study and for at least twelve weeks after the last dose of study drug.
  • Women of childbearing potential must have a negative pregnancy test prior to the first dose of study treatment.

Exclusion Criteria

  • Grade >1 neuropathy
  • Any active or chronic corneal disorder and Sjogren's syndrome.
  • Serious concurrent illness:
  • Any other concomitant anti-cancer treatment.
  • Women of childbearing potential who are pregnant or breast feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609556

Locations
United States, Kansas
University of Kansas Medical Center Research Institute
Fairway, Kansas, United States, 66205
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02062
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
CTRC at the University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H4A3J1
Sponsors and Collaborators
ImmunoGen, Inc.
  More Information

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT01609556     History of Changes
Other Study ID Numbers: IMGN853-0401 
Study First Received: May 30, 2012
Last Updated: October 12, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by ImmunoGen, Inc.:
FOLR solid tumors

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on December 09, 2016