Clinical trial · Interventional
A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck
A Phase 2 Study to Determine the Efficacy and Safety of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck
- 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)
BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree and squamous cell carcinoma of the head and neck. Ferumoxytol imaging will also be investigated at US sites as an exploratory endpoint.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIND-014 (docetaxel nanoparticles for injectable suspension) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the objective response rate (ORR) in patients with advanced urothelial carcinoma (transitional cell carcinoma), cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree and squamous cell carcinoma of the head and neck.
- timeFrame
- 18 weeks
- description
- Patients will be followed for ORR for an expected average of 18 weeks
Secondary outcomes (7)
- measure
- Progression Free Survival
- timeFrame
- Change in tumor size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average of 18 weeks.
- measure
- Overall Survival
- timeFrame
- Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree or squamous cell carcinoma of the head and neck. 2. Progressive disease after ≥ 1 prior chemotherapy regimen. 3. Patients with brain metastases are eligible if asymptomatic and neurologically stable for at least 4 weeks and are not taking any medications contraindicated 4. Chemotherapy must have been completed at least 4 weeks prior to initiation of study medication 5. ECOG performance status 0-1 6. Tumors must have measurable disease as per RECIST (version 1.1); 7. Female or male, 18 years of age or older 8. Adequate organ function 9. Life expectancy of \> 3 months Exclusion Criteria: 1. Current treatment on another therapeutic clinical trial 2. Prior treatment with docetaxel within 6 months of enrollment 3. Stage II, III or IV cardiac failure 4. Carcinomatous meningitis 5. Ongoing cardiac dysrhythmias 6. Peripheral neuropathy 7. Serious concomitant conditions 8. Pregnant or breast feeding 9. Known sensitivity to ferumoxytol 10. Hypersensitivity to polysorbate 80
References
Publications (0)
Data not yet available