Clinical trial · Interventional
DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])
A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): DSMB
Summary
Brief summary (as posted)
The primary objective of this study is: * To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary objectives of this study are: * To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots) * To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures) * A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcitriol | Drug | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically or cytologically proven adenocarcinoma of the prostate * Documented metastatic prostate adenocarcinoma * Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 * Adequate hematologic, renal and hepatic function * Life expectancy \>= 3 months Exclusion Criteria: * Prior chemotherapy, except estramustine * Prior chemotherapy with docetaxel * Prior isotope therapy (e.g., strontium-89, samarium-153, etc.) * One or more contraindications to the use of corticosteroids * History of cancer-related hypercalcemia
References
Publications (0)
Data not yet available