Studienregister

Studienregister der Deutschen Gesellschaft für Urologie e.V.

AP 59/10 - OGX-011-11

AcronymISRCTNEudraCTClinicaltrials.govDRKS
OGX-011-112010-021011-16NCT01188187

A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate Resistant Prostate Cancer

Status: Active

Purpose / Objectives

Primary Outcome

Overall Survival

Secondary Outcomes

  • Progression-free survival at Day 140
  • Safety profile
  • Progression-free survival at Day 225 [
  • PSA measurements

Diagnosis

Patient attributes

Stage

Metastatic Castrate Resistant Prostate Cancer

Age

18-100

Inclusion criteria

Selection:
Subjects must meet ALL of the following criteria to be eligible for inclusion into the study:
1. Age ≥ 18 years on the date of consent.
2. Histological or cytological diagnosis of adenocarcinoma of the prostate.
3. Metastatic disease on chest, abdominal, or pelvic CT and/or bone scan.
4. Systemic chemotherapy indicated due to progression while on or after androgen ablative therapy defined as:
...
8. Karnofsky score ≥ 70% (See Appendix 15.2).
9. At least 28 days has passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of ≤ 800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of randomization.
10. At least 4 weeks have passed since receiving any investigational agent at the time of randomization.
11. Has recovered from any other therapy-related toxicity to ≤ grade 2, (except alopecia, anemia and any signs or symptoms of androgen eprivation therapy).
12. Patient must be willing to not add, delete or change their current bisphosphonate usage throughout study treatment to assure that adverse event reporting is not confounded by changing their bisphosphonate usage (unless the deletion or change is for toxicity associated with bisphosphonate usage).
13. Written informed consent must be obtained prior to any protocol-specific procedures being performed.

Exclusion criteria

Auswahl:
Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study:
1. Received any other cytotoxic chemotherapy as treatment.
...
3. Participated in a prior clinical study evaluating custirsen.
4. History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. (Brain imaging for asymptomatic patients is not required.)
5. Current symptomatic cord compression requiring surgery or radiation therapy. (Once
successfully treated and there has been no progression, patients are eligible for the study.)
6. Active second malignancy (except non-melanomatous skin or superficial bladder cancer).
7. Uncontrolled medical conditions such as heart failure, myocardial infarction, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
....

Trial design

  • Phase III
  • Multicenter
  • Prospective
  • Randomized
  • Two-arm
  • Open Label

Intervention

Docetaxel and Prednisone versus Docetaxel and Prednisone und Custirsen Sodium

Documents (password protected)

Responsibilities in overall trial

Teva Pharmaceutical Industries

National Coordinating Investigator

PD Dr. Axel Merseburger

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