Trial Evaluating the Safety and Pharmacokinetics of MFGR1877S in Patients With Advanced Solid Tumors

An Open-Label, Multicenter, Phase I Dose-Escalation Trial Evaluating the Safety and Pharmacokinetics of MFGR1877S in Patients With Advanced Solid Tumors

This is a multicenter, open-label, dose-escalation study to assess the safety, tolerability and Pharmacokinetics of MGFR1877S.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: MFGR1877S

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
  • California
    • Santa Monica, California, United States, 90404
  • Colorado
    • Aurora, Colorado, United States, 80045
  • Illinois
    • Chicago, Illinois, United States, 60637
  • Tennessee
    • Nashville, Tennessee, United States, 37203

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Life expectancy >/= 12 weeks
• ECOG performance status of 0 or 1
• Histologic or cytologic documentation of locally advanced, or metastatic solid malignancy that has relapsed after or failed to respond to at least one prior regimen or for which there is no standard therapy
• Evaluable or measurable disease. Prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels (5 ng/mL measured 2 weeks apart) that meet the PSA Working Group criteria for progression prior to initiation of study treatment. Ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN (2 weeks apart prior to initiation of study treatment).
• Adequate hematologic and end organ function
• For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use an effective form of contraception and to continue its use until 90 days after the last dose of study treatment
• Consent to provide archival tissue

Exclusion Criteria:

• Prior use of any monoclonal antibody within 4 weeks before Cycle 1, Day 1
• Experimental therapy within 4 weeks prior to Cycle 1, Day 1
• Palliative radiotherapy within 2 weeks prior to Cycle 1, Day 1
• Prior anti-cancer therapy within 4 weeks prior to Cycle 1, Day 1
• Major surgical procedure or trauma within 4 weeks prior to Cycle 1, Day 1. All wounds must be fully healed on Cycle 1, Day 1.
• Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at screening or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1
• History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are allowed. Patients with a malignancy that has been treated with curative intent will also be allowed if the malignancy has been in remission without treatment for >/= years prior to Cycle 1, Day 1.
• Presence of positive test results for Hepatitis B (Hepatitis B surface antigen [HBsAg] and/or total HB core antibody [anti-HB-c]) or Hepatitis C (Hepatitis C virus [HCV] antibody serology testing). Patients positive for anti-HB-c are eligible only if PCR is negative for HBV DNA.
• Known history of HIV seropositive status
• Primary CNS malignancy, or untreated/active CNS metastases
• Pregnancy, lactation or breastfeeding
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A	Drug: MFGR1877S; Intravenous escalating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of dose dose limiting toxicities (DLTs) by NCI CTCAE, v4.0	Days 1-28 of Cycle 1
Nature of dose limiting toxicities (DLTs) by NCI CTCAE, v4.0	Days 1-28 of Cycle 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events by NCI CTCAE, v4.0	Up to 1 year
Nature of adverse events by NCI CTCAE, v4.0	Up to 1 year
Severity of adverse events by NCI CTCAE, v4.0	Up to 1 year

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Isabelle A. Rooney, M.B., Ch.B., Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: May 31, 2011
• First Posted (ESTIMATE): June 1, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Solid Cancers
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MFG4991g; GO27817 (OTHER: Hoffmann-La Roche)