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A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer
Phase 1, PHASE2 trial testing Cisplatin in Transitional Cell Carcinoma of Bladder in 68 participants. Completed in 11 April 2016.
| Lead sponsor | Altor BioScience |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 68 |
| Start date | 6 September 2011 |
| Primary completion | 11 April 2016 |
| Estimated completion | 11 April 2016 |
| Sites | 16 locations across United States |
Altor BioScience — full company profile →
18 and older, any sex, with Transitional Cell Carcinoma of Bladder or Urethra Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| ALT-801: 0.04 mg/kg, 0.06 mg/kg | 0.06 |
Number of AEs that occur or worsen after the first dose of study treatment
| Group | Value | 95% CI |
|---|---|---|
| ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine | 3 | |
| ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine | 49 | |
| ALT-801 0.06 mg/kg With Gemcitabine | 16 |
Objective response rate (ORR) is defined as confirmed complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors \[RECIST V1.0\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine | 100 | 29 – 100 |
| ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine | 47 | 33 – 62 |
| ALT-801 0.06 mg/kg With Gemcitabine | 6 | 0 – 30 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | ALT-801 0.04 mg/kg With Ci… | ALT-801 0.06 mg/kg With Ci… | ALT-801 0.06 mg/kg With Ge… |
|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Sepsis | Infections and infestations | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — |
| Duodenal ulcer | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Death | General disorders | — | — | — |
| Multiple organ dysfunction syndrome | General disorders | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Bacterial infection | Infections and infestations | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — |
| Urinary retention | Renal and urinary disorders | — | — | — |
| Urinary tract obstruction | Renal and urinary disorders | — | — | — |
| Confusional state | Psychiatric disorders | — | — | — |
| Embolism | Vascular disorders | — | — | — |
| Hypotension | Vascular disorders | — | — | — |
| Myocardial infarction | Cardiac disorders | — | — | — |
| Reaction | System | ALT-801 0.04 mg/kg With Ci… | ALT-801 0.06 mg/kg With Ci… | ALT-801 0.06 mg/kg With Ge… |
|---|---|---|---|---|
| Platelet count decreased | Investigations | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — |
| Chills | General disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Blood creatinine increased | Investigations | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — |
| Oedema peripheral | General disorders | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — | — |
| Hypophosphataemia | Metabolism and nutrition disorders | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — |
| White blood cell count decreased | Investigations | — | — | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Hypotension | Vascular disorders | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — | — |
| Pain | General disorders | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — |
| Weight decreased | Investigations | — | — | — |
Most-reported serious reactions: Dyspnoea, Sepsis, Pyrexia, Pleural effusion, Constipation, Abdominal pain, Ascites, Duodenal ulcer.
Data from ClinicalTrials.gov NCT01326871 adverse events section.
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 in a biochemotherapy regimen either containing cisplatin and gemcitabine or containing gemcitabine alone in patients who have muscle invasive or metastatic urothelial cancer of bladder, renal pelvis, ureters and urethra. The purpose of this study is to evaluate the safety, determine the maximum tolerated dose (MTD) and the recommended dose (RD), and assess the anti-tumor response of ALT-801 in combination with cisplatin and gemcitabine or ALT-801 in combination with gemcitabine alone. The pharmacokinetic profile of ALT-801 in combination with cisplatin and gemcitabine will also be assessed. The study includes a dose escalation phase (Phase Ib) and a dose expansion phase (Phase II). Phase II has two treatment groups, Expansion Group 1 and Expansion Group 2. Expansion Group 2 is for platinum-refractory patients, consisting of two treatment arms based on the patient's renal function. Patients will enroll to Expansion Group 2 after stage 1 of the Group 1 expansion is complete.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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