Phase 2
Completed N=70
A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)
Source: ClinicalTrials.gov NCT01106352 ↗Enrolled (actual)
70
Serious AEs
27.0%
Results posted
Nov 2016
Primary outcomePrimary: Number of Subjects With Dose-Limiting Toxicities - Dose Escalation Part — 0; 0; 0 Participants
Summary
The main purpose of this study is to establish a recommended dose of Alpharadin to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Dose-Limiting Toxicities - Dose Escalation Part |
0; 0; 0 | — |
| PRIMARY Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 |
3; 1; 4; 6; 3; 2 | — |
| PRIMARY Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period |
42; 43; 43; 42.7; 42.3; -2 | — |
| PRIMARY Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period |
533.1; 144; 224.6; 218.2; 195.9; -134 | — |
| PRIMARY Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period |
8.9; 6.7; 7.1; 7.5; 7; 2 | — |
| PRIMARY Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period |
2.231; 2.38; 2.309; 2.357; 2.307; 0.2 | — |
| PRIMARY Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period |
214.1; 196.3; 266.6; 259.6; 240.6; 169 | — |
| PRIMARY Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period |
3.99; 3.9; 3.9; 3.98; 4.02; -0.4 | — |
| PRIMARY Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period |
137.7; 113; 131.7; 139.2; 140.1; -2.7 | — |
| PRIMARY Changes From Baseline in Respiratory Rate During the Treatment Period |
19.3; 18.7; 19.1; 17.1; 17.5; -1.7 | — |
| PRIMARY Changes From Baseline in Heart Rate During the Treatment Period |
88.6; 58; 80; 77.9; 73.3; -0.2 | — |
| PRIMARY Changes From Baseline in Weight During the Treatment Period |
89.3; 81.9; 97.1; 87.7; 92; -1.8 | — |
| PRIMARY Number of Subjects With Physical Examination During the Treatment Period |
0; 0; 2; 5; 2; NA | — |
| PRIMARY Number of Subjects With Signs of Long-Term Radiation Toxicity |
2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate.
- Two or more bone metastases (hot spots) confirmed by bone scintigraphy within 8 weeks prior to study entry
- Known castration-resistant disease
- Karnofsky Performance Status (KPS): ≥70% within 14 days before start of study treatment (ECOG 1)
- Life expectancy at least 6 months.
- Acceptable hematology and serum biochemistry screening values
- Eligible for use of docetaxel according to the product information (package insert or similar).
Exclusion Criteria
- Has received an investigational therapeutic drug within the last 4 weeks prior to start of study treatment, or is scheduled to receive one during the treatment period.
- Has received external radiotherapy within the last 4 weeks prior to start of study treatment.
- Has an immediate need for radiotherapy.
- Has received prior hemibody external radiotherapy .
- Has received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases.
- Has received cytotoxic chemotherapy within the last 4 weeks prior to start of study treatment, or has not recovered to grade 1 or 0 from adverse events due to cytotoxic chemotherapy administered more than 4 weeks earlier.
- Has received more than ten previous infusions of docetaxel.
- Previous known experience of grade ≥ 3 docetaxel related toxicities or docetaxel toxicity related dose interruption or discontinuation.
- Previous use of G-CSF for persistent neutropenia after docetaxel treatment.
- Has received blood transfusion or erythropoietin (EPO) within the last 4 weeks prior to start of study treatment.
- Has received prior treatment with Alpharadin.
- Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
- Symptomatic nodal disease, i.e. scrotal, penile or leg edema.
- Visceral metastases from CRPC (>2 lung and/or liver metastases [size ≥2cm]), as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to start of study treatment.
- Uncontrolled loco-regional disease.
- Other primary tumor (other than CRPC) including haematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer).
- Has imminent or established spinal cord compression based on clinical findings and/or MRI.
- Unmanageable fecal incontinence
Data sourced from ClinicalTrials.gov (NCT01106352). 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.