Phase 1
Completed N=38
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
| Outcome | Result | p-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
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.