A Rollover Protocol of Dacomitinib For Patients In Japan

NCT02382796 | Completed Phase 2 Results

• 1 other identifier: A7471055
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study to permit continued access to dacomitinib for patients who participated in other dacomitinib monotherapy treatment protocols in Japan and have the potential to derive clinical benefit without unacceptable toxicity from continued dacomitinib treatment.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Were Previously Treated With Dacomitinib on the Parent Study in Japan and Who Got Access to Dacomitinib in This Extension Study

  To allow access to dacomitinib for participants who received dacomitinib on prior studies (A7471009 \[NCT01360554\] and A7471050 \[NCT01774721\]) in Japan and who had the potential to derive continued clinical benefit from single-agent dacomitinib treatment without unacceptable toxicity based upon the investigator's judgment.

  4 years

Secondary Outcomes (1)

• Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Day1 to up to 28-35 days after last dose, the range of treatment duration was 40-195 weeks

Study Arms (1)

Dacomitinib

EXPERIMENTAL

3 dose strengths (45 mg, 30 mg, and 15 mg), continuous oral daily dosing

Drug: Dacomitinib

Interventions

Dacomitinib DRUG

Starting at the current dose level in the prior study. Dose reductions and re-escalations are allowed based on tolerability. Patients may continue to be treated with dacomitinib on this protocol as long as there is evidence of clinical benefit in the judgment of the investigator.

Dacomitinib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who received dacomitinib on another clinical trial in Japan
• Evidence of a personally signed and dated informed consent document

You may not qualify if:

• Patients who meet one or more study withdrawal criteria on the prior study
• Participation in other studies involving other investigational drug(s) during study participation

Sponsors & Collaborators

• Pfizer: lead

Study Sites (6)

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 9208641, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Osaka City General Hospital Department of Clinical Oncology

Osaka, Osaka, 534-0021, Japan

Location

Kindai University Hospital

Sayama, Osaka, 589-8511, Japan

Location

Shizuoka Cancer Center

Suntougun, Shizuoka, 411-8777, Japan

Location

Cancer Institute Hospital,Japanese Foundation for Cancer Research

Koto-Ku, Tokyo, 135-8550, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

dacomitinib

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 9, 2015
• Study Start: July 10, 2015
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: July 2, 2020
• Results First Posted: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (6)