W/in 14 days registration: H&P, PS, ht, wt,
Novacea – 011-007
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FAST FACT
Novacea – 011-007
Phase 3, Randomized, Open-Label Study Evaluating DN101 in Combination w/ Docetaxel in AndrogenIndependent Prostate Cancer (AIPC) (Ascent-2)
W/in 7 days registration:
Questionnaires: QOL, Fatigue, & Pain
Screening labs processed thru Central Labs
(1-7 days before randomization)
CBC w/ diff, CMP, PSA, Serum Testosterone
Excluded Medications: See Section 8.1.1.7
Drug Provided: DN-101
Inclusion Criteria:
Start of TX w/in 3 days of randomization
 Histopathogically or cytologically proven adenocarcinoma
 Metastatic dz documented by CT, MRI, or bone scan
 Prior TX by androgen ablation: orchiectomy and/or luteinizing hormone releasing hormone (LHRH) agonists or antagonists
 If being treated with LHRH agonists or antagonists (i.e. w/out orchiectomy) the therapy must continue
 May have received any of the following hormonal therapies: Anti-androgens; Monotherapy with estramustine (> 4 weeks must
have elapsed since completion of prior estramustine therapy with full recovery from all side effects); prior therapy with
corticosteroids and/or ketoconazole, & other hormonal agents for therapy of prostate cancer
 Can be treated with bisphosphonates and can be continued
 Surgically / medically castrated – if medically castrated should continue on medical therapies to maintain medical castration. Pts
receiving an anti-androgen as part of 1st line therapy must have shown disease progression off the anti-androgen prior to enrollment
 Documented progression detected by rising PSA and/or imaging. Progression is defined as:
o PSA Progression: Elevated PSA (≥ 5 ng /ml) which has risen serially from baseline (#1) on two occasions each at least one wk
apart. If the confirmatory PSA (#3) is less than PSA #2, then a subsequent test for rising PSA (#4) is required & must be greater
than the 2nd measure (#2).
o Progression of target lesions: change in size of lymph nodes or parenchyma masses, on PE or x-rays (uni- or bidimensional)
(RECIST)
o Progression of non-target lesions (except bone) (RECIST).
o Bone scan progression: worsening bone scan with two or more new skeletal lesions that are felt to be consistent with tumor
flare. Patients with bone scan evidence of progression only must have a PSA ≥ 5 ng/ml.
 Prior XRT (exclude whole pelvic irradiation, to less than 25% of the bone marrow only) > 4 wks since completion of therapy
 Prior surgery > 4 wks since completion
 PS ≤ 2, Life expectancy ≥ 3 months, Age ≥ 18
 Adequate hematologic and metabolic values and testosterone < 50
Exclusion Criteria:
 Prior cytotoxic chemotherapy (except montherapy with estramustine); Prior isotope therapy (i.e., strontium-89, samarium-153, etc.)
 Prior malignancy except adequately treated basal cell or squamous cell skin cancer, or any cancer disease-free for > 5 years
 Known brain or leptomeningeal involvement. Patients with stable treated epidural lesions are eligible.
 Hx of cancer-related hypercalcemia, known hypercalcemia, or vitamin D toxicity
 Active uncontrolled infection; symptomatic PUD, unstable diabetes mellitus, or other contraindication for the use of corticosteroids
 Oher serious illness/medical condition which would interfere with patient’s ability to receive/comply study requirements.
 Symptomatic peripheral neuropathy > 2 (CTCAE V. 3)
 Hypersensitivity to drugs formulated with polysorbate-80 (form of docetaxel formulation), calcitriol
 Prior investigational therapy, calcitriol, paricalcitol < 28 days prior to randomization
TX until PD or unacceptable docetaxel toxicity (move to post-study TX phase) or unacceptable prednisone toxicity (move to F/U) or unacceptable
DN-101 toxicity (move to F/U).
TX
Agent
Dose
Route
Time
Duration
Prednisone
5 mg
PO
Starts D 1
BID
CONTROL
21 Day Cycle
Docetaxel
75 mg/m2
IV
D2
Over 1 hr
Dexamethasone
8 mg
PO
D2
1 hr prior to docetaxel , 3 hrs & 12 hrs
DN-101
45 μg
PO
D 1, 8, 15
Take on an empty stomach
ASCENT
28 Day Cycle
Docetaxel
36 mg/m2
IV
D 2, 9, 16
Over 30 minutes
Dexamethasone
8 mg
PO
D 2, 9, 16
1 hr prior to docetaxel , 3 hrs & 12 hrs
Post Study TX Phase: Initiated after unacceptable docetaxel toxicity & will continue until unacceptable DN-101/prednisone toxicity (move to F/U)
TX
Agent
Dose
Route
Time
Duration
CONTROL
Prednisone
5 mg
PO
D1
BID
28 Day Cycle
ASCENT
DN-101
45 μg
PO
D 1, 8, 15
Taken on an empty stomach
IRB Approved: February 2006 Pending