Clinical trial · Interventional
Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer
An Open Label Phase 1B Dose-Finding Study of TRC105 in Combination With Capecitabine for Progressive or Recurrent Metastatic Breast Cancer
NCT01326481CI-TRIAL-00037653TRC105completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the recommended phase 2 dose and overall safety and tolerability of TRC105 when given in combination with capecitabine for the treatment of patients with progressive or recurrent metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| TRC105 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single
- description
- All patients received TRC105 + capecitabine
- interventionNames
- Drug: TRC105
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Determine Maximum Tolerated Dose of TRC105 in Combination With Capecitabine
- timeFrame
- 1.5 years
- description
- Assess safety and dose limiting toxicity by dose cohort and coding all terms utilized MedDRA version 14.1.
Secondary outcomes (3)
- measure
- TRC105 Steady State Pharmacokinetic Trough Concentration at the RP2D
- timeFrame
- Cycle 2 day 1 (3 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven advanced solid cancer for which curative therapy is not available (Part 1 only) * Histologically proven metastatic Her-2-negative breast cancer (Part 2 only) * Measurable disease by RECIST 1.1 criteria (Part 2 only) * Willing and able to consent for self to participate in study * Progressive or recurrent disease after prior systemic chemotherapy regimen * Age ≥ 18 years * ECOG performance status of 0 or 1 * Resolution of all acute toxic effects of prior therapy to NCI CTCAE Grade ≤ 1 or baseline (except alopecia) * Adequate organ function Exclusion Criteria: * Prior treatment with more than one systemic chemotherapy regimen for metastatic disease. * Prior treatment with TRC105 * History of hypersensitivity reaction to antimetabolite therapy * Receipt of an investigational agent within 28 days of starting study treatment * Prior surgery (including open biopsy), radiation therapy or systemic therapy within 28 days of starting study treatment * Minor surgical procedures within 14 days prior to first dose of TRC105 * History of brain metastasis, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease * Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months * Uncontrolled chronic hypertension defined as systolic \> 140 or diastolic \> 90 despite optimal therapy * Past medical history of acquired or inherited coagulopathy including patients with known hereditary hemorrhagic telangiectasia * Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first dose with TRC105 * Cardiac dysrhythmias of NCI CTCAE Grade ≥ 2 within the last month * Hemorrhage within 28 days of starting study treatment * Unhealed wounds within 28 days of starting study treatment * History of peptic ulcer disease or 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 * Known active viral or nonviral hepatitis * History of hypersensitivity reaction to human or mouse antibody products * Lung cancer with central chest lesions * Pregnancy or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.