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

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01363024
• Collaborator: (none)
• Enrollment: 24
• Locations: 5
• Arm: 1
• Duration (Months): 19
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: MFGR1877S	Phase 1

Study Design

• Study Type: Interventional
• 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: Aug 1, 2011
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: MFGR1877S; Intravenous escalating dose

Outcome Measures

Primary Outcome Measures

1. Incidence of dose dose limiting toxicities (DLTs) by NCI CTCAE, v4.0 [Days 1-28 of Cycle 1]

2. Nature of dose limiting toxicities (DLTs) by NCI CTCAE, v4.0 [Days 1-28 of Cycle 1]

Secondary Outcome Measures

1. Incidence of adverse events by NCI CTCAE, v4.0 [Up to 1 year]

2. Nature of adverse events by NCI CTCAE, v4.0 [Up to 1 year]

3. Severity of adverse events by NCI CTCAE, v4.0 [Up to 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Scottsdale	Arizona	United States	85258
2		Santa Monica	California	United States	90404
3		Aurora	Colorado	United States	80045
4		Chicago	Illinois	United States	60637
5		Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Genentech, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01363024
• Other Study ID Numbers: MFG4991g; GO27817
• First Posted: Jun 1, 2011
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Genentech, Inc.: Solid Cancers
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Nov 2, 2016