Safety and Tolerability
Primary
· Participants are followed while actively taking study drug and for at least 30 days post last dose.
Number of Participants with Adverse Events
| Group | Value | 95% CI |
|---|---|---|
| All Patients | 4 |
Last reviewed · How we verify
NCT01994590
Dovitinib (TKI258) and Abiraterone Acetate in Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
Terminated
Phase 2
Results posted
Last updated 19 March 2019
What this trial tests
Phase 2 trial testing Dovitinib in Prostate Cancer in 4 participants. Terminated before completion.
Timeline
19 May 2014
Primary endpoint
5 June 2017
5 June 2017
5 June 2017
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 19 May 2014 |
| Primary completion | 5 June 2017 |
| Estimated completion | 5 June 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dovitinib
- Abiraterone Acetate (ABIRATERONE) — full drug profile →
- Prednisone (prednisone) — full drug profile →
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse events — posted to ClinicalTrials.gov
Time frame: First study drug dose, until 30 days after the last dose of study drug, unless the participant withdraws consent. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
All Patients
Serious: 1/4 (25%)
Deaths: 0/4
Serious adverse events (2 terms)
| Reaction | System | All Patients |
|---|---|---|
| Thromboembolic Event | Blood and lymphatic system disorders | — |
| Skin Infection | Skin and subcutaneous tissue disorders | — |
Other adverse events (24 terms — click to expand)
| Reaction | System | All Patients |
|---|---|---|
| Fatigue | Metabolism and nutrition disorders | — |
| Aspartate aminotransferase increase | Hepatobiliary disorders | — |
| Platelet count decreased | Blood and lymphatic system disorders | — |
| Alanine aminotransferase increased | Hepatobiliary disorders | — |
| Alkaline phophatase increased | Hepatobiliary disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypomagnesium | Metabolism and nutrition disorders | — |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Hot flashes | Vascular disorders | — |
| Hypertension | Vascular disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hypotension | Vascular disorders | — |
| Localized edema | Blood and lymphatic system disorders | — |
| Neutrophil count decreased | Blood and lymphatic system disorders | — |
| Proteinuria | Renal and urinary disorders | — |
| Thromboembolic event | Vascular disorders | — |
| Urinary tract infection | Renal and urinary disorders | — |
| Urinary urgency | Renal and urinary disorders | — |
| White blood cell decreased | Blood and lymphatic system disorders | — |
Most-reported serious reactions: Thromboembolic Event, Skin Infection.
Data from ClinicalTrials.gov NCT01994590 adverse events section.
Sponsor's own description
The goal of this clinical research study is to learn if adding dovitinib to the combination of abiraterone acetate and prednisone may help to control metastatic CRPC. The safety of this drug combination will also be studied.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting the androgen receptor pathway in castration-resistant prostate cancer: progresses and prospects.
Ferraldeschi R, Welti J, Luo J, Attard G, et al · · 2015 · cited 151× · PMID 24837363 · DOI 10.1038/onc.2014.115 -
Targeting the adaptive molecular landscape of castration-resistant prostate cancer.
Wyatt AW, Gleave ME. · · 2015 · cited 107× · PMID 25896606 · DOI 10.15252/emmm.201303701 -
Epithelial-to-Mesenchymal Transition-Related Markers in Prostate Cancer: From Bench to Bedside.
Gogola S, Rejzer M, Bahmad HF, Abou-Kheir W, et al · · 2023 · cited 21× · PMID 37190236 · DOI 10.3390/cancers15082309 -
Molecular mechanisms and targeted therapy for the metastasis of prostate cancer to the bones (Review).
Xu Y, Zhang G, Liu Y, Liu Y, et al · · 2024 · cited 3× · PMID 39301646 · DOI 10.3892/ijo.2024.5692 -
Impact of cell plasticity on prostate tumor heterogeneity and therapeutic response.
Archer M, Lin KM, Kolanukuduru KP, Zhang J, et al · · 2024 · cited 2× · PMID 39839748 · DOI 10.62347/yfrp8901
Verify or expand the search:
- PubMed search for NCT01994590
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT01994590 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 19 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01994590.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing