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Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone in Patients Renal Cell Carcinoma
Phase 1, PHASE2 trial testing TRC105 and Axitinib in Renal Cell Carcinoma in 173 participants. Terminated before completion.
| Lead sponsor | Tracon Pharmaceuticals Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 173 |
| Start date | 8 March 2013 |
| Primary completion | 21 December 2018 |
| Estimated completion | 12 June 2019 |
| Sites | 39 locations across United Kingdom, United States, Hungary, Czechia |
Tracon Pharmaceuticals Inc. — full company profile →
18 and older, any sex, with Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1b: For dose limiting toxicity (DLT) evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0).
| Group | Value | 95% CI |
|---|---|---|
| P1b: 8 mg/kg TRC105 Wkly + 5 mg Axitinib BID | 0 | |
| P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID | 0 | |
| P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID | 0 |
Median progression free survival (PFS) of patients with advanced or metastatic RCC by RECIST 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| Group | Value | 95% CI |
|---|---|---|
| P2 Arm A: 5 mg Axitinib BID | 11.4 | 5.8 – NA |
| P2 Arm B: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID | 6.7 | 5.6 – 13.1 |
Number of patients with partial response (PR) or complete response (CR) by RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| P1b: 8 mg/kg TRC105 Wkly + 5 mg Axitinib BID | 0 | |
| P2 Arm A: 5 mg Axitinib BID | 22 | |
| P2 Arm B: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID | 23 | |
| P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID | 5 | |
| P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID | 0 |
Overall response (OR) rate is the number of patients with partial response (PR) or complete response (CR) by Choi Criteria. Per Choi criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), A decrease in size ≥ 10% or a decrease in tumor attenuation (Houndsfield units) ≥ 15% on CT and no new lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| P2 Arm A: 5 mg Axitinib BID | 50 | |
| P2 Arm B: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID | 50 |
Trough Serum TRC105 concentrations at steady state (cycle 2 day 15) were measured using validated ELISA methods.
| Group | Value | 95% CI |
|---|---|---|
| P1b: 8 mg/kg TRC105 Wkly + 5 mg Axitinib BID | 27650 | ± 39103 |
| P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID | 140022 | ± 45403.01 |
| P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID | 54375 | ± 23546.5 |
Anti-product antibody concentration were measured using validated ELISA methods.
| Group | Value | 95% CI |
|---|---|---|
| P1b: 8 mg/kg TRC105 Wkly + 5 mg Axitinib BID | 1 | |
| P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID | 0 | |
| P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID | 0 |
Time frame: 2 years, 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | P1b: 8 mg/kg TRC105 Wkly +… | P1b: 10 mg/kg TRC105 Wkly … | P1b: 10 mg/kg Wkly/15 mg/k… | P2 Arm A: 5 mg Axitinib BID | P2 Arm B: 10 mg/kg TRC105 … |
|---|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Disease Progression | General disorders | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — | — | — |
| Acute Kidney Injury | Renal and urinary disorders | — | — | — | — | — |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Chest Pain | General disorders | — | — | — | — | — |
| Encephalopathy | Nervous system disorders | — | — | — | — | — |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | — | — | — | — | — |
| Myocardial Infarction | Cardiac disorders | — | — | — | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — | — |
| Acute Heart Failure | Cardiac disorders | — | — | — | — | — |
| Liver Injury | Hepatobiliary disorders | — | — | — | — | — |
| Biliary Tract Infection | Infections and infestations | — | — | — | — | — |
| Bronchial Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — |
| Retinal Vein Occlusion | Eye disorders | — | — | — | — | — |
| Cholecystitis | Hepatobiliary disorders | — | — | — | — | — |
| Clostridium Difficile Infection | Infections and infestations | — | — | — | — | — |
| Clostridium Difficile Colitis | Infections and infestations | — | — | — | — | — |
| Gallbladder Perforation | Gastrointestinal disorders | — | — | — | — | — |
| Confusional State | Psychiatric disorders | — | — | — | — | — |
| Deep Vein Thrombosis | Vascular disorders | — | — | — | — | — |
| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Colitis | Gastrointestinal disorders | — | — | — | — | — |
| Reaction | System | P1b: 8 mg/kg TRC105 Wkly +… | P1b: 10 mg/kg TRC105 Wkly … | P1b: 10 mg/kg Wkly/15 mg/k… | P2 Arm A: 5 mg Axitinib BID | P2 Arm B: 10 mg/kg TRC105 … |
|---|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Weight Decreased | Investigations | — | — | — | — | — |
| Decreased Appetite | Metabolism and nutrition disorders | — | — | — | — | — |
| Gingival Bleeding | Gastrointestinal disorders | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — |
| Hypothyroidism | Endocrine disorders | — | — | — | — | — |
| Infusion Related Reaction | Injury, poisoning and procedural complications | — | — | — | — | — |
| Palmar-plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Proteinuria | Renal and urinary disorders | — | — | — | — | — |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Abdominal Pain Upper | Gastrointestinal disorders | — | — | — | — | — |
| Chills | General disorders | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — | — |
| Mucosal Inflammation | General disorders | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — |
| Asthenia | General disorders | — | — | — | — | — |
| Blood Creatinine Increased | Investigations | — | — | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — | — | — |
| Oral Pain | Gastrointestinal disorders | — | — | — | — | — |
Most-reported serious reactions: Anaemia, Disease Progression, Dehydration, Abdominal Pain, Acute Kidney Injury, Pulmonary Embolism, Chest Pain, Encephalopathy.
Data from ClinicalTrials.gov NCT01806064 adverse events section.
Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI
8 peer-reviewed publications reference this trial (live from Europe PMC):
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