Clinical trial · Interventional
Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer
A Phase I/II Study to Assess the Safety and Therapeutic Effect of INCB007839 in Combination With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer.
NCT01254136CI-TRIAL-00006130terminatedPhase 1 / Phase 2ClinicalTrials.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): Incyte has suspended development of the compound.
Summary
Brief summary (as posted)
This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INCB007839 300mg BID | Drug | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment A - INCB007839 300mg BID
- description
- This is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine.
- interventionNames
- Drug: INCB007839 300mg BID
- Drug: Trastuzumab
- Drug: Vinorelbine
Primary outcomes (1)
- measure
- Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations.
- timeFrame
- Measured monthly starting at Baseline (estimated duration 6-9 months)
Secondary outcomes (1)
- measure
- Overall objective response rate assessed by RECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer * Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2 * Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions * Subject with presence of measurable disease based on RECIST 1.1 * Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer Exclusion Criteria: * Subject with Left ventricular ejection fraction (LVEF) below institutional normal range * Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable * Subject with current active malignancy other than breast cancer * Subject with prior history of other malignancy except for cancers from which the patient is currently disease free * Subject with significant renal or hepatic dysfunction * Subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy * Subject with insufficient bone marrow function * Subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy. * Subject with current active bacterial, Hepatitis B or C, and/or HIV infections
References
Publications (1)
- DERIVEDPark EJ, Lee CW. Soluble receptors in cancer: mechanisms, clinical significance, and therapeutic strategies. Exp Mol Med. 2024 Feb;56(1):100-109. doi: 10.1038/s12276-023-01150-6. Epub 2024 Jan 5. PMID 38182653