Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01106352
First received: April 16, 2010
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Bone Metastases
Castration-Resistant Prostate Cancer
Drug: Radium-223 dichloride (Xofigo, BAY88-8223) + docetaxel
Drug: Docetaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Dose-escalation: Assessment of dose-limiting toxicities [ Time Frame: When 6 weeks post-injection data are available for the first combined injection of Alpharadin/docetaxel ] [ Designated as safety issue: Yes ]
  • 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) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Exploratory patient self-reporting of pain intensity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 63
Study Start Date: July 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alpharadin + docetaxel Drug: Radium-223 dichloride (Xofigo, BAY88-8223) + docetaxel
Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection. In the randomized phase IIa part of the protocol, the dose established in the dose-escalation part of the protocol (Phase I) will be used, i.e. 5 doses of 50 kBq/kg b.w. every 6 weeks in combination with the approved step-down dose of docetaxel (60 mg/m2) administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone.
Active Comparator: Docetaxel alone Drug: Docetaxel
Docetaxel (75 mg/m2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m2 is allowed as per the approved docetaxel label.

Detailed Description:

The trial was initially conducted and submitted by Algeta ASA. After acquiring Algeta, Bayer is now the sponsor.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106352

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01106352     History of Changes
Other Study ID Numbers: 15469, BC1-10
Study First Received: April 16, 2010
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
The target population is patients with bone metastasis from castration-resistant prostate cancer intended for treatment with docetaxel

Additional relevant MeSH terms:
Bone Marrow Diseases
Bone Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Prostatic Neoplasms
Bone Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Hematologic Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014