Trial of TRC105 and Sorafenib in Patients With HCC

Overview

NCT ID: NCT02560779
Sponsor Protocol Number: 105HCC101

About this study

The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with hepatocellular carcinoma. Up to 18 patients will be treated. The purpose of the phase 2 portion is to estimate the ORR of patients with hepatocellular carcinoma by RECIST 1.1. Up to 21 patients will be treated in phase 2.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Patients must have confirmed hepatocellular carcinoma (HCC) by histopathology or imaging criteria according to AASLD guidelines.
  2. Patients must have disease that is not amenable to potentially curative resection or ablative techniques or that has recurred following ablative techniques. In addition, disease must not be amenable to transhepatic arterial chemoembolization (TACE) or must have progressed on TACE. Patients must not be candidates for liver transplantation.
  3. If liver cirrhosis is present, patient must have a Child-Pugh A or B (7 points) classification.
  4. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission per investigators' clinical judgment.
  5. Measurable disease by RECIST 1.1 (Phase 2 only)
  6. Age of 18 years or older
  7. ECOG performance status ≤ 1
  8. Resolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ≤ 1 or baseline
  9. Adequate organ function
  10. Willingness and ability to consent to participate in study
  11. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  12. Men who are sterile OR agree to use at least two forms of a reliable and highly effective method of birth control and to not donate sperm and for at least 180 days following last dose of TRC105 or sorafenib.
  13. Woman of non-child bearing potential due to surgical sterilization confirmed by medical history or menopause, OR woman of child bearing potential who test negative for pregnancy at time of enrollment based on serum pregnancy test and agree to use at least 2 forms of a reliable and highly effective method of birth control during the study and for at least 180 days after stopping TRC105 or sorafenib.

Exclusion Criteria:

  1. Prior anticancer systemic therapy
  2. Current treatment on another therapeutic clinical trial
  3. Prior radiation therapy within 28 days of starting the study treatment
  4. No major surgical procedure or significant traumatic injury within 6 weeks prior to study registration, and must have fully recovered from any such procedure.
  5. Proteinuria
  6. Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy.
  7. History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
  8. Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, PTCA or CABG within the past 6 months.
  9. Active bleeding or pathologic condition that carries a high risk of bleeding. No bleeding diathesis.
  10. Thrombolytic use within 10 days prior to first day of study therapy
  11. History of hemorrhage or hemoptysis (> ½ teaspoon bright red blood) within 3 months of starting study treatment
  12. Need for anticoagulation
  13. History of liver transplant
  14. History of bleeding esophageal varices in previous 6 months, which have not been adequately managed with banding or sclerotherapy.
  15. History of peptic ulcer disease within 3 months of treatment.
  16. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
  17. Patients may not have received a strong CYP3A4 inducer within 12 days prior to registration nor a strong CYP3A4 inhibitor within 7 days prior to registration
  18. Patients with known hypersensitivity to Chinese hamster ovary products or other recombinant human, chimeric, or humanized antibodies.
  19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality

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