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A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Cancers

Thank you

Trial Information

A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors


Inclusion Criteria:



- 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

Inclusion Criteria Unique to Arm A:

- 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

Inclusion Criteria Unique to Arm B:

- Histologically or cytologically documented, incurable, locally advanced, or
metastatic solid malignancy; a maximum of two prior chemotherapy regimens is allowed

Exclusion Criteria:

- 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

- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or
recent peripheral arterial thrombosis) within 6 months prior to Day 1

- History of hemoptysis within 1 month prior to Day 1

- Evidence of bleeding diathesis or significant coagulopathy in the absence of stable
therapeutic anticoagulation

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1 or anticipation of need for major surgical procedure during the course
of the study

- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to Day 1

- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
within 6 months prior to Day 1

- Clinical signs or symptoms of gastrointestinal obstruction or requirement for
parenteral hydration, parenteral nutrition, or tube feeding because of an active
gastrointestinal condition

- Evidence of abdominal free air not explained by paracentesis or recent surgical
procedure

- Serious, non-healing wound, active gastrointestinal ulcer, or untreated bone fracture

- Intrathoracic lung carcinoma of squamous cell histology

- Grade ≥ 2 sensory neuropathy

- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that, in the investigator's opinion, gives 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

- Known hypersensitivity to recombinant human antibodies

Exclusion Criterion Unique to Arm B:

- Known significant hypersensitivity to paclitaxel or other drugs using the vehicle
cremophor

Type of Study:

Interventional

Study Design:

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and nature of dose-limiting toxicities (DLTs)

Outcome Time Frame:

Through study completion or early study discontinuation

Safety Issue:

No

Principal Investigator

Rainer Brachmann, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

ANP4667g

NCT ID:

NCT00954642

Start Date:

August 2009

Completion Date:

Related Keywords:

  • Solid Cancers
  • Solid Tumor
  • Locally Advanced Solid Tumor
  • Avastin

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