Clinical trial · Interventional
Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy
A Randomized, Double-blind, Multicentre, Phase II Controlled Trial Assessing ZACTIMATM (Vandetanib) Against Placebo in Prolonging the Off-treatment Interval in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy
NCT00686036CI-TRIAL-00025237ZENITHterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment
Summary
Brief summary (as posted)
The purpose of this study is to determine whether treatment with Zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy.
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 |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| vandetanib | Drug | Vandetanib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- vandetanib
- description
- 300 mg orally, once daily for up to 18 months
- interventionNames
- Drug: vandetanib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- orally, once daily for up to 18 months
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)
- timeFrame
- 52 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of prostate cancer * Prostate specific antigen (PSA) greater than or equal to 5 ng/mL * Recent completion of first hormone treatment \[intermittent androgen deprivation with a Luteinising hormone releasing hormone (LHRH) analogue\] * Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1) Exclusion Criteria: * Bone or soft tissue metastases * Significant cardiovascular disease including hypertension not controlled by medical therapy or history of irregular heart beats or recent heart attack
References
Publications (0)
Data not yet available
No reference posted for this study.