Trial Evaluating the Safety and Pharmacokinetics of MFGR1877S in Patients With Advanced Solid Tumors
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumor | Drug: MFGR1877S | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: A |
Drug: MFGR1877S
Intravenous escalating dose |
- 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 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363024
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 |
Study Director: | Isabelle A. Rooney, M.B., Ch.B. | Genentech, Inc. |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT01363024 |
Other Study ID Numbers: |
MFG4991g GO27817 ( Other Identifier: Hoffmann-La Roche ) |
First Posted: | June 1, 2011 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Solid Cancers |
Neoplasms |