Clinical trial NCT00773383: A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy.
Official title: An Open-label Study to Determine the Effect of R1507 Plus Tarceva (Erlotinib) on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) With Progressive Disease After Clinical Benefit to Second or Third Line Tarceva Monotherapy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or third line Tarceva monotherapy will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* male or female patients \>=18 years with histologically documented inoperable, locally advanced or metastatic (stage IIIB or IV) NSCLC;
* currently receiving Tarceva monotherapy and having failed at least one standard chemotherapy regimens;
* prior response or stable disease 12 weeks from start of Tarceva;
* documented progressive disease at enrollment;
* measurable disease according to the RECIST criteria;
* ECOG performance status 0-2;
* life expectancy \>12 weeks.

Exclusion Criteria:

* patients with active CNS lesions;
* prior treatment with agents acting via IGF-1R inhibition or EGFR targeting;
* administration with high doses of systemic corticosteroids;
* radiotherapy in the 4 weeks prior to study start;
* surgery or significant traumatic injury with in the last 2 weeks prior to study start.

Primary outcomes:
measure: Percentage of Participants With Progression Free Survival (PFS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Duration of Overall Survival
timeFrame: From start of treatment to death; up to the time that all participants ended treatment
measure: Participants Achieving Objective Response
timeFrame: Patients were followed from start of therapy until date of first response
measure: Time to Best Response
timeFrame: Patients were followed from start of therapy until date of first response
measure: Time to Progressive Disease (PD)
timeFrame: From start of therapy to the date of first documentation of PD. Pts who never progress prior to final analysis or are withdrawn from the study without documented progression will be censored at the date of the last valid tumor assessment.
measure: Duration of Objective Response
timeFrame: from the date the complete or partial response was first recorded to the date which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken
measure: Baseline Electrocardiogram (ECG)
timeFrame: baseline within 28 days of starting treatment (screening visit).
measure: Fasting Glucose, Highest Post-Baseline Value
timeFrame: Baseline, Highest Post-Baseline value within the timeframe of post-baseline collection up to when patient discontinued (up to 59 weeks)
measure: Hemoglobin A1c (HbA1c)
timeFrame: screening
measure: Monthly Urine Pregnancy Test in Female Patients of Childbearing Potential
timeFrame: Within 7 days of starting treatment (baseline visit)
measure: Number of Participants With Positive Results for Human Anti-human Antibody (HAHA) Testing
timeFrame: prior to dosing on week 1 (day 1), week 4 (day 22), week 10 (day 64), final visit, follow up visit and 12 weeks post last dose (up to 71 weeks)
measure: Electrocardiogram (ECG)
timeFrame: baseline and thereafter as clinically indicated at the discretion of the investigator up to the time that the patient discontinued (up to 59 weeks)
measure: Population Pharmacokinetics of R1507 and Tarceva
timeFrame: Throughout study
measure: Assessment of Potential Predictive and Prognostic Biomarkers.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Santa Monica
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Hickory
country: United States
state: North Carolina
city: Calgary
country: Canada
state: Alberta
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Marseille
country: France
city: Paris
country: France
city: Villejuif
country: France
city: Gdansk
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: