Study of TRC105 Combined With Standard-Dose Bevacizumab for Advanced Solid Tumors for Which Bevacizumab is Indicated

NCT ID: NCT01332721

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of the study is to evaluate safety and tolerability and determine a recommended Phase 2 dose for TRC105 when added to standard dose bevacizumab in patients with advanced solid tumors for which bevacizumab is indicated.

Detailed Description

Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in patients with a wide variety of solid tumor types. TRC105, a monoclonal antibody to CD105, is a novel angiogenesis inhibitor that complements bevacizumab in preclinical models. Together, these antibodies may result in more effective angiogenesis inhibition and improved clinical efficacy over that seen with bevacizumab alone. The purpose of the study is to evaluate safety and tolerability and determine a recommended Phase 2 dose for TRC105 when added to standard dose bevacizumab in patients with advanced solid tumors for which bevacizumab is indicated.

Conditions

Adult Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TRC105 and Bevacizumab

Escalating doses of i.v. TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks. Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.

Group Type: EXPERIMENTAL

TRC105 and Bevacizumab

Intervention Type: DRUG

Escalating doses of i.v. TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks. Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.

Interventions

TRC105 and Bevacizumab

Escalating doses of i.v. TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks. Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.

Intervention Type: DRUG

Other Intervention Names

Chimeric Antibody (TRC105) to CD105; Avastin

Eligibility Criteria

Inclusion Criteria

1. Histologically proven advanced or metastatic solid cancer

2. Measurable disease, evaluable disease or elevation of a relevant soluble tumor marker (e.g., CEA, PSA, CA125)

3. Age of 18 years or older

4. ECOG performance status of 0 or 1

5. Resolution of all acute AEs resulting from prior cancer therapies to NCI CTCAE Grade ≤ 1 or baseline (except alopecia)

6. Adequate organ function

7. Willing and able to consent for self to participate in study

Exclusion Criteria

1. Prior treatment with TRC105

2. Serious dose-limiting toxicity related to prior bevacizumab

3. Current treatment on another therapeutic clinical trial

4. Receipt of an investigational agent within 28 days of starting study treatment

5. Prior surgery (including open biopsy) within 28 days of starting the study treatment

6. Prior radiation therapy or systemic therapy within 21 days of starting the study treatment

7. Minor surgical procedures such as fine needle aspirations, Mediport placement or core biopsies within 7 days of study treatment

8. Uncontrolled chronic hypertension defined as systolic > 140 or diastolic > 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry allowed provided that the average of 3 BP readings at a visit prior to enrollment is < 140/90 mm Hg)

9. Symptomatic pericardial or pleural effusions

10. Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2 weeks

11. History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease (except in the expansion cohort at the MTD where brain metastases or primary brain tumors are eligible)

12. Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months

13. Active bleeding or pathologic condition that carries a high risk of bleeding

14. Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy

15. Cardiac dysrhythmias of NCI CTCAE Grade ≥ 2 within the last 28 days

16. Known active viral or nonviral hepatitis

17. Centrally located non-small cell lung cancer (regardless of histologic sub-type), or non-small cell lung cancer of squamous histology.

18. History of hemorrhage or hemoptysis (>½ teaspoon bright red blood) within 6 months of starting study treatment

19. Open wounds or unhealed fractures within 28 days of starting study treatment

20. History of peptic ulcer disease or erosive gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment

21. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness

22. Pregnancy or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tracon Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles P Theuer, MD

Role: STUDY_DIRECTOR

Tracon Pharmaceuticals Inc.

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Pinnacle Oncology Hematology

Scottsdale, Arizona, United States

UCLA Hematology and Oncology

Santa Monica, California, United States

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

105ST102

Identifier Type: -

Identifier Source: org_study_id