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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01526928




Registration number
NCT01526928
Ethics application status
Date submitted
31/01/2012
Date registered
6/02/2012
Date last updated
4/08/2020

Titles & IDs
Public title
Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients
Scientific title
A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral Rociletinib in Patients With Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
CO-1686-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rociletinib
Treatment: Drugs - Rociletinib
Treatment: Drugs - Rociletinib
Treatment: Drugs - Rociletinib
Treatment: Drugs - Rociletinib
Treatment: Drugs - Rociletinib

Experimental: Rociletinib <900 mg BID FB formulation - Rociletinib free base (FB) dose <900 mg twice a day (BID)

Experimental: Rociletinib 900 mg BID FB formulation - Rociletinib free base (FB) dose 900 mg twice a day (BID)

Experimental: Rociletinib 500 mg BID HBr formulation - Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID)

Experimental: Rociletinib 625 mg BID HBr formulation - Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID)

Experimental: Rociletinib 750 mg BID HBr formulation - Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID)

Experimental: Rociletinib 1000 mg BID HBr formulation - Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID)


Treatment: Drugs: Rociletinib
Phase 1: Rociletinib <900 mg BID FB will be administered in escalating dosages in a period of 21-day cycles

Treatment: Drugs: Rociletinib
Phase 1: Rociletinib 900 mg BID FB will be administered in escalating dosages in a period of 21-day cycles

Treatment: Drugs: Rociletinib
Phase 1: Rociletinib 500 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles
Phase 2: Rociletinib 500 mg BID HBr will be administered daily

Treatment: Drugs: Rociletinib
Phase 1: Rociletinib 625 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles
Phase 2: Rociletinib 625 mg BID HBr will be administered daily

Treatment: Drugs: Rociletinib
Phase 1: Rociletinib 750 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles
Phase 2: Rociletinib 750 mg BID HBr will be administered daily

Treatment: Drugs: Rociletinib
Phase 1: Rociletinib 1000 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles
Phase 2: Rociletinib 1000 mg BID HBr will be administered daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of T790M Positive Patients With Confirmed Response Per Investigator
Timepoint [1] 0 0
Cycle 1 Day 1 to End of Treatment, up to approximately 42 months
Primary outcome [2] 0 0
Duration of Response (DOR) in T790M Positive Patients According to RECIST Version 1.1 as Determined by Investigator Assessment
Timepoint [2] 0 0
Cycle 1 Day 1 to End of Treatment, up to approximately 36 months
Primary outcome [3] 0 0
Dose Limiting Toxicity (DLT) Incidence
Timepoint [3] 0 0
Cycle 1 Day 1 to Cycle 1 Day 21
Secondary outcome [1] 0 0
Overall Survival (OS) Determined by Investigator Assessment
Timepoint [1] 0 0
Cycle 1 Day 1 to date of death, assessed up to 42 months
Secondary outcome [2] 0 0
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
Timepoint [2] 0 0
Cycle 1 Day 1 to End of Treatment, up to approximately 42 months
Secondary outcome [3] 0 0
PK Profile of Rociletinib - Cmax
Timepoint [3] 0 0
Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
Secondary outcome [4] 0 0
PK Profile of Rociletinib - Tmax
Timepoint [4] 0 0
Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
Secondary outcome [5] 0 0
PK Profile of Rociletinib - AUC 0-24
Timepoint [5] 0 0
Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
Secondary outcome [6] 0 0
PK Profile of Rociletinib - T 1/2
Timepoint [6] 0 0
Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days
Secondary outcome [7] 0 0
Food Effect on PK of Rociletinib - Cmax
Timepoint [7] 0 0
Day -7 prior to Cycle 1 Day 1, or approximately 7 days
Secondary outcome [8] 0 0
Food Effect on PK of Rociletinib - Tmax
Timepoint [8] 0 0
Day -7 prior to Cycle 1 Day 1, or approximately 7 days
Secondary outcome [9] 0 0
Food Effect on PK of Rociletinib - AUC 0-24
Timepoint [9] 0 0
Day -7 prior to Cycle 1 Day 1, or approximately 7 days
Secondary outcome [10] 0 0
Food Effect on PK of Rociletinib - C24
Timepoint [10] 0 0
Day -7 prior to Cycle 1 Day 1, or approximately 7 days
Secondary outcome [11] 0 0
Food Effect on PK of Rociletinib - T 1/2
Timepoint [11] 0 0
Day -7 prior to Cycle 1 Day 1, or approximately 7 days
Secondary outcome [12] 0 0
QTcF Values Post Baseline by Daily Dose
Timepoint [12] 0 0
Screening to End of Treatment, up to approximately 42 months
Secondary outcome [13] 0 0
QTcF Value Change From Baseline
Timepoint [13] 0 0
Screening to End of Treatment, up to approximately 42 months
Secondary outcome [14] 0 0
Objective Response Rate (ORR), Duration of Response (DOR) and Progression-Free Survival (PFS) Per RECIST Version 1.1 as Determined by IRR
Timepoint [14] 0 0
Cycle 1 Day 1 to End of Treatment / End of Follow-up

Eligibility
Key inclusion criteria
Inclusion Criteria -

All patients must meet the following inclusion criteria:

1. Metastatic or unresectable locally advanced NSCLC

2. Evidence of a tumor with one or more EGFR mutations excluding exon 20 insertion

3. Biopsy of either primary or metastatic tumor tissue within 60 days of dosing

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

5. Minimum age of 18 years

6. Adequate hematological and biological function

7. Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any
study-specific evaluation

Phase 2 Cohorts must also meet the following inclusion criteria:

- Disease progression confirmed by radiologic assessment while on treatment with EGFR-
TKI Or

- Disease progression confirmed by radiologic assessment while on treatment with the
first single agent EGFR TKI and

- Documented evidence of T790M mutation in EGFR following disease progression on the
first single agent EGFR TKI.

- Measureable disease according to RECIST Version 1.1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria -

Any of the following criteria will exclude patients from study participation:

1. Documented evidence of an Exon 20 insertion activating mutation in the EGFR gene

2. Active second malignancy

3. Known pre-existing interstitial lung disease

4. Patients with Leptomeningeal carcinomatosis are excluded. Other CNS metastases are
only permitted if treated, asymptomatic and stable (not requiring steroids for at
least 4 weeks prior to start of study treatment).

5. Treatment with prohibited medications less than or equal to 14 days prior to treatment
with rociletinib

6. 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

7. Prior treatment with rociletinib or other drugs that target T790M positive mutant EGFR
with sparing of wild type EGFR

8. Certain cardiac abnormalities or history

9. Non-study related surgical procedures less than or equal to 7 days prior to
administration of rociletinib

10. Females who are pregnant or breastfeeding

11. Refusal to use adequate contraception for fertile patients (females and males) for 12
weeks after the last dose of rociletinib

12. Presence of any serious or unstable concomitant systemic disorder incompatible with
the clinical study

13. Any other reason the investigator considers the patient should not participate in the
study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/08/2018
Sample size
Target
Accrual to date
Final
612
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
France
State/province [21] 0 0
Provence Alpes COTE D'azur
Country [22] 0 0
France
State/province [22] 0 0
Rhone-alpes
Country [23] 0 0
France
State/province [23] 0 0
Caen Cedex 05
Country [24] 0 0
France
State/province [24] 0 0
Creteil cedex
Country [25] 0 0
France
State/province [25] 0 0
Lille
Country [26] 0 0
France
State/province [26] 0 0
Villejuif
Country [27] 0 0
Poland
State/province [27] 0 0
Gdansk

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Clovis Oncology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI)
that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while
sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK)
and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or
recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of
rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01526928
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01526928