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Phase 1 Completed N=38 Treatment

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

Adult Solid Tumor
Source: ClinicalTrials.gov NCT01332721 ↗
Enrolled (actual)
38
Serious AEs
23.7%
Results posted
Mar 2014
Primary outcomePrimary: Determine Maximum Tolerated Dose of TRC105 in Combination With Bevacizumab — 10 mg/kg

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Determine Maximum Tolerated Dose of TRC105 in Combination With Bevacizumab
10
SECONDARY
TRC105 Pharmacokinetic Concentrations
SECONDARY
Immune Response to TRC105
3; 23; 4; 22
SECONDARY
Objective Response According to RECIST 1.1
2; 14

Eligibility Criteria

Inclusion Criteria

  • Histologically proven advanced or metastatic solid cancer
  • Measurable disease, evaluable disease or elevation of a relevant soluble tumor marker (e.g., CEA, PSA, CA125)
  • Age of 18 years or older
  • ECOG performance status of 0 or 1
  • Resolution of all acute AEs resulting from prior cancer therapies to NCI CTCAE Grade ≤ 1 or baseline (except alopecia)
  • Adequate organ function
  • Willing and able to consent for self to participate in study

Exclusion Criteria

  • Prior treatment with TRC105
  • Serious dose-limiting toxicity related to prior bevacizumab
  • Current treatment on another therapeutic clinical trial
  • Receipt of an investigational agent within 28 days of starting study treatment
  • Prior surgery (including open biopsy) within 28 days of starting the study treatment
  • Prior radiation therapy or systemic therapy within 21 days of starting the study treatment
  • Minor surgical procedures such as fine needle aspirations, Mediport placement or core biopsies within 7 days of study treatment
  • 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 ½ teaspoon bright red blood) within 6 months of starting study treatment
  • Open wounds or unhealed fractures within 28 days of starting study treatment
  • 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
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
  • Pregnancy or breastfeeding
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01332721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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