A Study of MNRP1685A in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors

NCT00954642 | Completed Phase 1

• 1 other identifier: ANP4667g
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase Ib, open-label, dose-escalation study of MNRP1685A given by intravenous (IV) infusion as therapy for locally advanced or metastatic solid tumors.

Conditions

Solid Cancers

Keywords

Solid Tumor; Locally Advanced Solid Tumor; Avastin

Outcome Measures

Primary Outcomes (1)

• Incidence and nature of dose-limiting toxicities (DLTs)

  Through study completion or early study discontinuation

Secondary Outcomes (1)

• Pharmacokinetic (PK) parameters of MNRP1685A and bevacizumab, when appropriate, as data allow (total exposure, maximum and minimum serum concentration, clearance, and volume of distribution)

  Through study completion or early study discontinuation

Study Arms (2)

A

EXPERIMENTAL

Drug: bevacizumab; Drug: MNRP1685A

B

EXPERIMENTAL

Drug: bevacizumab; Drug: MNRP1685A; Drug: paclitaxel

Interventions

bevacizumab DRUG

Intravenous repeating dose

A; B

MNRP1685A DRUG

Escalating intravenous dose

A; B

paclitaxel DRUG

Intravenous repeating dose

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adequate hematologic and end organ function
• Evaluable disease or measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST)
• Agreement to use an effective form of contraception for the duration of the study
• Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen
• Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy; a maximum of two prior chemotherapy regimens is allowed

You may not qualify if:

• Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks or 5 half-lives (for systemic agents), whichever is shorter, prior to initiation of study treatment with the following exceptions: hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists or antagonists for prostate cancer; herbal therapy \> 1 week prior to Day 1; hormone-replacement therapy or oral contraceptives; palliative radiotherapy for bone metastases \> 2 weeks prior to Day 1
• Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava
• Leptomeningeal disease as a manifestation of the current malignancy
• Active infection requiring IV antibiotics
• Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs, inhaled corticosteroids, or the equivalent of ≤ 10 mg/day prednisone
• Bisphosphonate therapy for symptomatic hypercalcemia
• Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
• Known human immunodeficiency virus (HIV) infection
• Known primary CNS malignancy, or untreated or active CNS metastases
• Pregnancy, lactation or breast feeding
• Inadequately controlled hypertension
• History of hypertensive crisis or hypertensive encephalopathy
• History of myocardial infarction or unstable angina within 6 months prior to Day 1
• New York Heart Association (NYHA) Class II or greater CHF
• History of stroke or transient ischemic attack (TIA) within 6 months prior to Day 1

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Interventions

Bevacizumab; vesencumab; Paclitaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Rainer Brachmann, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 7, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 17, 2017

Record last verified: 2017-05