Bone Metastases Clinical Trial
Official title:
A Phase I/IIa Study of Safety and Efficacy of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer
Verified date | July 2015 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-escalation: Assessment of dose-limiting toxicities | When 6 weeks post-injection data are available for the first combined injection of Alpharadin/docetaxel | Yes | |
Primary | Expanded safety cohort: Safety of combining Alpharadin with docetaxel (incidence and severity of adverse events and serious adverse events, changes from baseline in laboratory variables, vital signs and physical examination) | 12 months | Yes | |
Secondary | Signs of long-term radiation toxicity: incidence of manifestations of potential late toxicity, such as new primary cancers and bone marrow changes (acute myelogenous leukaemia, myelodysplastic syndrome, and aplastic anaemia) | 12 months | Yes | |
Secondary | Exploratory efficacy measurements of Alpharadin in combination with docetaxel versus docetaxel alone such as changes in bone markers, PSA and CTC, time to progression and overall survival | 12 months | No | |
Secondary | Exploratory patient self-reporting of pain intensity | 12 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03986593 -
Cryoablation of Bone Metastases From Endocrine Tumors
|
N/A | |
Active, not recruiting |
NCT01996046 -
FDG PET/CT in Breast Cancer Bone Mets
|
||
Completed |
NCT01358539 -
Palliation: the Effect of Education on Pain
|
Phase 3 | |
Terminated |
NCT00981578 -
ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain
|
N/A | |
Terminated |
NCT00757757 -
A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases
|
Phase 1/Phase 2 | |
Completed |
NCT00762346 -
Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis
|
Phase 4 | |
Completed |
NCT00420433 -
Bone Response in Metastatic Breast Cancer Involving Bones
|
N/A | |
Completed |
NCT02826382 -
Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041
|
Early Phase 1 | |
Terminated |
NCT05301062 -
A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
|
||
Recruiting |
NCT06367491 -
National Database of Bone Metastases
|
||
Completed |
NCT03223727 -
Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223
|
||
Completed |
NCT00830180 -
Open Label Extension In Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03305224 -
The Combination Therapy With Ra-223 and Enzalutamide
|
Phase 2 | |
Withdrawn |
NCT04109937 -
External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy Trial
|
N/A | |
Active, not recruiting |
NCT02880943 -
Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL)
|
Phase 1/Phase 2 | |
Completed |
NCT01696760 -
Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology
|
N/A | |
Completed |
NCT00958477 -
A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer
|
Phase 1 | |
Completed |
NCT03979118 -
Exercise Prescription in Patients With Bone Metastases
|
||
Completed |
NCT03353090 -
Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients
|
N/A | |
Recruiting |
NCT05167669 -
Pain Relief in Symptomatic Bone Metastases With Adjuvant Hyperthermia MR Guided HIFU
|
Early Phase 1 |