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TIGER-2: A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-directed TKI in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT02147990
Recruitment Status : Active, not recruiting
First Posted : May 28, 2014
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Rociletinib Phase 2

Detailed Description:

This is a Phase 2, single arm, open-label, dual cohort, multicenter study evaluating the safety and efficacy of rociletinib administered orally to patients with previously treated mutant EGFR NSCLC.

Patients will be enrolled into 2 cohorts. Cohort A will enroll approximately 125 eligible patients who are centrally confirmed T790M-positive. Cohort B will be a continuation of the study and will enroll up to approximately 100 eligible patients who will be either centrally confirmed T790M-positive or T790M-negative.

All patients (for Cohort A and B) should have experienced disease progression while on treatment with the first single-agent EGFR-directed TKI (EGFR-TKI) for advanced/metastatic NSCLC. One line of chemotherapy prior to the EGFR-TKI treatment is permissible.

The study (Cohorts A and B) will consist of a screening phase to establish study eligibility and document baseline measurements, an open-label treatment phase, in which the patient will receive rociletinib to ascertain safety and efficacy until disease progression as defined by RECIST Version 1.1, clinical tumor progression, or unacceptable toxicity as assessed by the investigator. For patients with clinical progression, radiographic assessment should be performed to document evidence of radiographic progression.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TIGER-2: A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-directed TKI in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC)
Study Start Date : April 2014
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Rociletinib Mono-Therapy Drug: Rociletinib
Rociletinib will be administered to patients orally
Other Name: CO-1686




Primary Outcome Measures :
  1. Objective Response rate (ORR) according to RECIST Version 1.1 as determined by independent radiology review (IRR). [ Time Frame: Every 8 weeks until disease progression, up to approximately 24 months ]

Secondary Outcome Measures :
  1. Duration of Response (DR), Disease Control Rate (DCR) and Progression Free Survival (PFS) according to RECIST Version 1.1 as determined by IRR [ Time Frame: Every 8 weeks until disease progression, up to approximately 24 months ]
  2. Objective Response Rate (ORR), Duration of Response (DR), Progression Free Survival (PFS), Disease Control Rate (DCR) as determined by Investigator Assessment [ Time Frame: Every 8 weeks until disease progression, up to approximately 24 months ]
  3. Overall Survival [ Time Frame: Every 4-8 weeks until date of death, up to approximately 60 months ]
  4. Change from baseline in patient reported outcomes using EORTC QLQ C30, EORTC Quality of Life Questionnaire Lung Cancer module (EORTC QLQ LC13), and the Dermatology Life Quality Index (DLQI) [ Time Frame: Every 8-12 weeks until disease progression, up to approximately 24 months ]
  5. Treatment emergent adverse events (AEs), laboratory abnormalities and ECG abnormalities [ Time Frame: Every 4 weeks until treatment discontinuation, up to approximately 24 months ]
  6. Plasma PK parameters for rociletinib based on sparse sampling [ Time Frame: Every 4 weeks for approximately 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC
  • Documented evidence of a tumor with 1 or more EGFR mutations excluding exon 20 insertion
  • Disease progression confirmed by radiologic assessment while receiving treatment with the first single agent EGFR-TKI
  • EGFR TKI treatment discontinued less than or equal to 30 days prior to planned initiation of rociletinib
  • The washout period for an EGFR inhibitor is a minimum of 3 days
  • No intervening treatment between cessation of single agent EGFR TKI and planned initiation of rociletinib
  • Previous treatment with less than or equal to 1 prior chemotherapy (excluding prior neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent)
  • Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1 or less
  • Central laboratory confirmation of the presence of the T790M mutation in tumor tissue in Cohort A and the presence or absence of the T790M mutation in tumor tissue in Cohort B. Centrally indeterminate, unknown or invalid specimens are not acceptable. Biopsy material obtained from either primary or metastatic tumor tissue and sent to the central laboratory must be within 60 prior to dosing study drug but following disease progression on the first EGFR TKI
  • Measurable disease according to RECIST Version 1.1
  • Life expectancy of at least 3 months
  • ECOG performance status of 0 to 1
  • Minimum Age 18 years (in certain territories, the minimum age requirement may be higher eg age 20 years in Japan and Taiwan)
  • Adequate hematological and biological function, confirmed by defined laboratory values
  • Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study specific evaluation

Exclusion Criteria

  • Documented evidence of an exon 20 insertion activating mutation in the EGFR gene
  • Active second malignancy i.e. patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment
  • Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enrol in the trial provided all chemotherapy was completed greater than 6 months prior and/or bone marrow transplant greater than 2 years prior
  • Known pre-existing interstitial lung disease
  • Cohort A only: Patients with leptomeningeal carcinomatosis are excluded. Other central nervous system (CNS) metastases are only permitted if treated, asymptomatic, and stable (not requiring steroid for at least 4 weeks prior to the start of study treatment). Cohort B only: Patients with CNS metastases or leptomeningeal carcinomatosis are excluded.
  • Treatment with prohibited medications less than or equal to 14 days prior to treatment with rociletinib
  • Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication before starting rociletinib
  • Prior treatment with rociletinib, or other drugs that target T790M positive mutant EGFR with sparing of wild type EGFR
  • Any of the following cardiac abnormalities or history
  • Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTCF) greater than 450 msec
  • Inability to measure QT interval on ECG
  • Personal or family history of long QT syndrome
  • Implantable pacemaker or implantable cardioverter defibrillator
  • Resting bradycardia less than 55 beats/min
  • Non-study related surgical procedures less than or equal to 7 days prior to administration of rociletinib. In all cases, the patient must be sufficiently recovered and stable before treatment administration
  • Females who are pregnant or breastfeeding
  • Refusal to use adequate contraception for fertile patients (females and males) while on treatment and for 12 weeks after the last dose of rociletinib
  • Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
  • Any other reason the investigator considers the patient should not participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147990


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Sponsors and Collaborators
Clovis Oncology, Inc.

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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02147990     History of Changes
Other Study ID Numbers: CO-1686-019 (TIGER-2)
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Keywords provided by Clovis Oncology, Inc.:
cancer
metastatic
locally advanced
lung
non-small cell lung cancer
NSCLC
epidermal growth factor receptor
EGFR
T790M
CO-1686
unresectable
recurrent
EGFR-directed therapy
irreversible EGFR inhibitor
TIGER
Rociletinib
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms