Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363024
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE May 27, 2011
First Posted Date  ICMJE June 1, 2011
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE August 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
  • Incidence of dose dose limiting toxicities (DLTs) by NCI CTCAE, v4.0 [ Time Frame: Days 1-28 of Cycle 1 ]
  • Nature of dose limiting toxicities (DLTs) by NCI CTCAE, v4.0 [ Time Frame: Days 1-28 of Cycle 1 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
  • Incidence of adverse events by NCI CTCAE, v4.0 [ Time Frame: Up to 1 year ]
  • Nature of adverse events by NCI CTCAE, v4.0 [ Time Frame: Up to 1 year ]
  • Severity of adverse events by NCI CTCAE, v4.0 [ Time Frame: Up to 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Evaluating the Safety and Pharmacokinetics of MFGR1877S in Patients With Advanced Solid Tumors
Official Title  ICMJE An Open-Label, Multicenter, Phase I Dose-Escalation Trial Evaluating the Safety and Pharmacokinetics of MFGR1877S in Patients With Advanced Solid Tumors
Brief Summary This is a multicenter, open-label, dose-escalation study to assess the safety, tolerability and Pharmacokinetics of MGFR1877S.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE Drug: MFGR1877S
Intravenous escalating dose
Study Arms  ICMJE Experimental: A
Intervention: Drug: MFGR1877S
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2013)
24
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2011)
38
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01363024
Other Study ID Numbers  ICMJE MFG4991g
GO27817 ( Other Identifier: Hoffmann-La Roche )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Isabelle A. Rooney, M.B., Ch.B. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP