CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)

NCT01199068 | Completed Phase 1 Results

• 1 other identifier: CS7017-A-A110
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with erlotinib, and to assess the pharmacokinetics of CS-7017 in combination with erlotinib.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

PPAR gamma agonist; Tumor; Cancer; Antineoplastic Agent; Respiratory Tract Neoplasms; Erlotinib; Protein Kinase Inhibitors; Neoplasms

Outcome Measures

Primary Outcomes (4)

• CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy

  A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. A CS-7017-related TEAE is an TEAE that is related to CS7017 in the relationship.

  From post first dose to 30 days after last dose, up to approximately 1.5 years

• Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer

  After the first CS-7017 administration, area under the concentration-time curve from zero to the last quantifiable concentration (AUClast) and area under the concentration-time curve during dosing interval (AUCtau) were assessed.

  Cycle 1, Week 1 and Cycle 2, Week 4

• Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer

  After the first CS-7017 administration, observed serum concentration (Cmax) and observed serum concentration at steady state (Cmax,ss) were assessed.

  Cycle 1, Week 1 and Cycle 2, Week 4

• Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer

  After the first CS-7017 administration, time of maximum plasma concentration (Tmax) and time of maximum plasma concentration at steady state (Tmax,ss) were assessed.

  Cycle 1, Week 1 and Cycle 2, Week 4

Secondary Outcomes (3)

• Best Overall Response and Response Rate Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy

  From screening and after completion of every 2 cycles (6 weeks) until disease progression, withdrawal of consent, death, or loss to follow-up, up to approximately 1.5 years

• Progression-free Survival Time Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy

  From randomization to PD or death, up to approximately 1.5 years

• Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy

  From post first dose to 30 days after last dose, up to approximately 1.5 years

Study Arms (1)

CS-7017+Erlotinib

EXPERIMENTAL

Drug: CS-7017 from 0.25 mg to 0.50 mg twice a daily Drug: Erlotinib 150 mg once daily

Drug: CS-7017; Drug: Erlotinib

Interventions

CS-7017 DRUG

CS-7017 from 0.25 mg to 0.50 mg twice daily

Also known as: CS7017

CS-7017+Erlotinib

Erlotinib DRUG

Erlotinib 150 mg once daily

Also known as: Tarceva

CS-7017+Erlotinib

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed unresectable locally advanced or metastatic (stage IIIb or IV) Non-small Cell Lung Cancer (NSCLC)
• Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first-line platinum based therapy
• Male or female ≥ 18 years of age
• Anticipation of more than 3 months survival
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
• Adequate organ and bone marrow function

You may not qualify if:

• Prior Tyrosine Kinase Inhibitor (TKI) therapy
• Anticipation of need for a major surgical procedure or radiation therapy during the study
• Remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment
• Treatment with anticancer medication within 4 weeks before study treatment, currently enrolled in another investigational drug study, or enrolled in another investigational drug study within 4 weeks of start of treatment
• History of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I Congestive Heart Failure (CHF), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe Chronic-Obstructive Pulmonary Disease (COPD) or asthma)
• Severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy
• Subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms)
• Subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis B surface antigen (HBsAg)-, hepatitis C virus (HCV)- or human immunodeficiency virus (HIV)-positive or receiving antiretroviral therapy
• Subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction
• Diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications
• Treatment with Thiazolidinedione(TZDs) within 4 weeks prior to start of study treatment
• History of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin
• Poorly-controlled blood pressure as judged by the Investigator

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead
• ICON Clinical Research: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Songpa-Gu, 138-736, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Respiratory Tract Neoplasms

Interventions

efatutazone; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 10, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 13, 2021
• Results First Posted: July 31, 2020

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

KR (1)