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Clinical trial · no report yet · Phase 1/Phase 2
NP28673 trial (alectinib): what clinicians have said so far
A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment
- NCT01801111 ↗
- Completed
- Hoffmann-La Roche
- Focused size, estimated: 1–150 verified statements once built
We haven't built an HCP commentary report on NP28673 (alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on NP28673 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Indexed so far | |
|---|---|
| 4 posts on X, typically up to 18 once built |
The trial
ClinicalTrials.gov- Official title
- An Open-Label, Non-Randomized, Multicenter Phase I/II Trial of RO5424802 Given Orally to Non-Small Cell Lung Cancer Patients Who Have ALK Mutation and Who Have Failed Crizotinib Treatment
- Phase
- Phase 1/Phase 2
- Status
- Completed
- Conditions
- Non-Small-Cell Lung Carcinoma
- Interventions
- Erlotinib; Alectinib
- Arms
- Alectinib · Experimental
- Enrollment
- 138
- Primary outcomes
- Recommended Phase 2 Dose (RP2D) of Alectinib
- Percentage of Participants With Dose Limiting Toxicities (DLTs)
- Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) as Assessed by Independent Radiological Review Committee (IRC) in Response Evaluable (RE) Population
- Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Pretreated Participants
- Sponsor
- Hoffmann-La Roche
- Start
- Jun 20, 2013
- Primary completion
- Oct 24, 2014
- Results posted
- Yes
- Registry record
- NCT01801111 · updated Nov 2, 2018
Publications
linked from the registry- Ou SI, Gadgeel SM, Barlesi F, Yang JC, De Petris L, Kim DW, Govindan R, Dingemans AM, Crino L, Lena H, Popat S, Ahn JS, Dansin E, Mitry E, Muller B, Bordogna W, Balas B, Morcos PN, Shaw AT. Pooled overall survival and safety data from the pivotal phase II studies (NP28673 and NP28761) of alectinib in ALK-positive non-small-cell lung cancer. Lung Cancer. 2020 Jan;139:22-27. doi: 10.1016/j.lungcan.2019.10.015. Epub 2019 Oct 14. PubMed 31706099
- Morcos PN, Nueesch E, Jaminion F, Guerini E, Hsu JC, Bordogna W, Balas B, Mercier F. Exposure-response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer. Cancer Chemother Pharmacol. 2018 Jul;82(1):129-138. doi: 10.1007/s00280-018-3597-5. Epub 2018 May 10. PubMed 29748847
- Gadgeel SM, Shaw AT, Govindan R, Gandhi L, Socinski MA, Camidge DR, De Petris L, Kim DW, Chiappori A, Moro-Sibilot DL, Duruisseaux M, Crino L, De Pas T, Dansin E, Tessmer A, Yang JC, Han JY, Bordogna W, Golding S, Zeaiter A, Ou SI. Pooled Analysis of CNS Response to Alectinib in Two Studies of Pretreated Patients With ALK-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Dec;34(34):4079-4085. doi: 10.1200/JCO.2016.68.4639. Epub 2016 Oct 31. PubMed 27863201