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A Phase I/IIa Study of Safety and Efficacy of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Bone Metastases, Castration-Resistant Prostate Cancer

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Trial Information

A Phase I/IIa Study of Safety and Efficacy of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer


Within the U.S:, the trial is conducted under an IND sponsored by Bayer.


Main

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).

Main 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 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Dose-escalation: Assessment of dose-limiting toxicities

Outcome Time Frame:

When 6 weeks post-injection data are available for the first combined injection of Alpharadin®/docetaxel

Safety Issue:

Yes

Principal Investigator

Michael J Morris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

BC1-10

NCT ID:

NCT01106352

Start Date:

July 2010

Completion Date:

October 2014

Related Keywords:

  • Bone Metastases
  • Castration-Resistant Prostate Cancer
  • The target population is patients with bone metastasis from castration-resistant prostate cancer intended for treatment with docetaxel
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Northwestern UniversityChicago, Illinois  60611
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Washington, Seattle Cancer Care AllianceSeattle, Washington  98109
Universit of San FranciscoSan Francisco, California  94115
Northshore University Health System, Kellogg Cancer CenterEvanston, Illinois  60201