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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01363024
First received: May 27, 2011
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Solid Tumour
Drug: MFGR1877S
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Phase I Dose-Escalation Trial Evaluating the Safety and Pharmacokinetics of MFGR1877S in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence of dose dose limiting toxicities (DLTs) by NCI CTCAE, v4.0 [ Time Frame: Days 1-28 of Cycle 1 ] [ Designated as safety issue: No ]
  • Nature of dose limiting toxicities (DLTs) by NCI CTCAE, v4.0 [ Time Frame: Days 1-28 of Cycle 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events by NCI CTCAE, v4.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Nature of adverse events by NCI CTCAE, v4.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Severity of adverse events by NCI CTCAE, v4.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: MFGR1877S
Intravenous escalating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01363024

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
Santa Monica, California, United States, 90404
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Tennessee
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Genentech
Investigators
Study Director: Isabelle A. Rooney, M.B., Ch.B. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01363024     History of Changes
Other Study ID Numbers: MFG4991g, GO27817
Study First Received: May 27, 2011
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Solid Cancers

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014