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Clinical Trial 19575

Cancer Type: Neurologic Oncology
Interventions:Depatuxizumab Mafodotin; Naphazoline; Prednisolone Acetate; Temodal (Temozolomide); Temozolomide

Study Type: Supportive Care
Phase of Study: Phase III
Investigators:

  • Hsiang-Hsuan (Michael) Yu

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Phase 3b Study for Management of Ocular Side Effects in Subjects with EGFR-Amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)

Summary

Objective

Primary Objective:Estimate the percentage of subjects in each prophylactic treatment arm who require a change in OSE management due to inadequate control of OSEs. Secondary Objective:Assess the effects of intervention with bandage contact lenses (BCL) on visual acuity and OSE symptom severity for those subjects who require intervention due to inadequate control of OSEs.

Inclusion Criteria

  • Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.
  • Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification and be supratentorial in location.
  • Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.
  • Participant has a Karnofsky performance status (KPS) of 70 or higher.
  • Participant has adequate bone marrow, renal, and hepatic function.
  • Electrocardiogram without evidence of acute cardiac ischemia > Participant has a life expectancy of 3 months of more.

  • Exclusion Criteria

  • Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.
  • Participant has hypersensitivity to any component of TMZ or dacarbazine.
  • Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) prior to Study Day 1.
  • Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
  • Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.
  • Participant has a history of herpetic keratitis.
  • Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.
  • Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.
  • Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).