Pancreatic Cancer
Conditions
Brief summary
This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Interventions
DRUGErlotinib, escalating dose
100mg, PO, once daily, escalating to a maximum of 250mg, PO, once daily
DRUGErlotinib, standard dose
100mg, PO, once daily
DRUGGemcitabine
1000 mg/m2, IV, on days 1,8 and 15 of each 4 week cycle
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * histologically or cytologically confirmed pancreatic cancer with measurable or non-measurable metastatic disease; * ECOG performance status of 0-1.
Exclusion criteria
* local, or locally advanced, pancreatic cancer; * prior systemic treatment for metastatic pancreatic cancer; * \<=6 months since last adjuvant chemotherapy; * other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Died Assessed From Point of Randomization | Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months. | Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. |
| OS Assessed From Point of Randomization | Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months. | OS assessed from the point of randomization was defined as the median time, in months, from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. The 95 percent (%) confidence interval (CI) was determined using Kaplan-Meier methodology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months. | BOR was defined as a confirmed CR or PR for at least 4 weeks. CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. The 95% CI for one sample binomial was determined using Pearson-Clopper method. |
| Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months. | CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months. | Disease control was defined as a participant with a response of CR or PR for at least 4 weeks at any time during treatment, or SD that was maintained for at least 8 weeks after the start of treatment. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization | Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months. | Progression-free survival (PFS) as assessed from the point of randomization was defined as the time from randomization to the first occurrence of progressive disease (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause. For target lesions (TLs), PD was defined as at least a 20% increase in the sum of longest diameter (SLD) of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. |
| OS Assessed From Start of 4-Week Run-In | BL and weekly thereafter for up to 46 months. | OS assessed from the start of the 4-week run in period was defined as the median time, in months, from BL to the date of death, due to any cause. Participants who were still alive at the time of analysis were censored at the date they were last known to be alive. The 95% CI was determined using Kaplan-Meier methodology. |
| Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months. | PFS as assessed from the start of 4-week run-in was defined as the time from BL to the first occurrence of PD according to RECIST or death due to any cause. For TLs, PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. |
| PFS Assessed From the Start of 4-Week Run-In | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months. | PFS assessed from the start of 4-week run-in was defined as the median time, in weeks, from BL to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology. |
| Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In | BL and weekly thereafter for up to 46 months. | OS assessed from the start of the 4-week run in period was defined as the time from BL to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. |
| PFS Assessed From Point of Randomization | Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months. | PFS assessed from the point of randomization was defined as the median time, in weeks, from randomization to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Denmark, France, Germany, Greece, Hong Kong, Israel, Italy, Lithuania, Mexico, Poland, Romania, Serbia, Singapore, Spain, Taiwan, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| G+E: Rash ≥ Grade 2 Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months. | 106 |
| G+E Standard Dose: Rash Grade < 2 Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months. | 75 |
| G+E Escalating Dose: Rash Grade < 2 Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months. | 70 |
| G+E: No Rash Non-Eligible Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months. | 179 |
| G+E: Early Drop Out Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks. | 36 |
| Total | 466 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 8 | 4 | 7 | 17 | 13 |
| Overall Study | Death | 5 | 4 | 1 | 8 | 5 |
| Overall Study | Lack of Efficacy | 84 | 58 | 53 | 133 | 13 |
| Overall Study | Other | 5 | 2 | 3 | 4 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Refused treatment | 3 | 7 | 6 | 17 | 5 |
| Overall Study | Violation of Selection Criteria | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | G+E: Rash ≥ Grade 2 | G+E Standard Dose: Rash Grade < 2 | G+E Escalating Dose: Rash Grade < 2 | G+E: No Rash Non-Eligible | G+E: Early Drop Out |
|---|---|---|---|---|---|---|
| Age, Customized ≥ 65 Years | 205 participants | 40 participants | 32 participants | 36 participants | 82 participants | 15 participants |
| Age, Customized Less Than (<) 65 Years | 261 participants | 66 participants | 43 participants | 34 participants | 97 participants | 21 participants |
| Sex: Female, Male Female | 208 Participants | 41 Participants | 41 Participants | 34 Participants | 77 Participants | 15 Participants |
| Sex: Female, Male Male | 258 Participants | 65 Participants | 34 Participants | 36 Participants | 102 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 105 / 105 | 74 / 77 | 71 / 71 | 178 / 178 | 34 / 36 |
| serious Total, serious adverse events | 39 / 105 | 24 / 77 | 20 / 71 | 64 / 178 | 22 / 36 |
Outcome results
Primary
OS Assessed From Point of Randomization
OS assessed from the point of randomization was defined as the median time, in months, from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. The 95 percent (%) confidence interval (CI) was determined using Kaplan-Meier methodology.
Time frame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| G+E Standard Dose: Rash Grade < 2 | OS Assessed From Point of Randomization | 8.4 months |
| G+E Escalating Dose: Rash Grade < 2 | OS Assessed From Point of Randomization | 7.0 months |
p-value: 0.202695% CI: [0.88, 1.8]Log Rank
Primary
Percentage of Participants Who Died Assessed From Point of Randomization
Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.
Time frame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Population: Full analysis set (FAS): all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| G+E Standard Dose: Rash Grade < 2 | Percentage of Participants Who Died Assessed From Point of Randomization | 81.3 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants Who Died Assessed From Point of Randomization | 85.7 percentage of participants |
Secondary
OS Assessed From Start of 4-Week Run-In
OS assessed from the start of the 4-week run in period was defined as the median time, in months, from BL to the date of death, due to any cause. Participants who were still alive at the time of analysis were censored at the date they were last known to be alive. The 95% CI was determined using Kaplan-Meier methodology.
Time frame: BL and weekly thereafter for up to 46 months.
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| G+E Standard Dose: Rash Grade < 2 | OS Assessed From Start of 4-Week Run-In | 7.9 months |
| G+E Escalating Dose: Rash Grade < 2 | OS Assessed From Start of 4-Week Run-In | 9.3 months |
| G+E Escalating Dose: Rash Grade < 2 | OS Assessed From Start of 4-Week Run-In | 8.0 months |
p-value: 0.267895% CI: [0.6, 1.15]Log Rank
p-value: 0.844995% CI: [0.74, 1.43]Log Rank
Secondary
Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In
OS assessed from the start of the 4-week run in period was defined as the time from BL to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.
Time frame: BL and weekly thereafter for up to 46 months.
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| G+E Standard Dose: Rash Grade < 2 | Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In | 84.9 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In | 81.3 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In | 85.7 percentage of participants |
Secondary
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST
BOR was defined as a confirmed CR or PR for at least 4 weeks. CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. The 95% CI for one sample binomial was determined using Pearson-Clopper method.
Time frame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| G+E Standard Dose: Rash Grade < 2 | Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST | 14.7 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST | 8.6 percentage of participants |
p-value: 0.254395% CI: [-17.2, 5]Chi-squared
95% CI: [0.19, 1.56]
Secondary
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST
CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Time frame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| G+E Standard Dose: Rash Grade < 2 | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | PR | 14.7 percentage of participants |
| G+E Standard Dose: Rash Grade < 2 | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | PD | 25.3 percentage of participants |
| G+E Standard Dose: Rash Grade < 2 | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | SD | 58.7 percentage of participants |
| G+E Standard Dose: Rash Grade < 2 | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | Missing (no response assessment) | 1.3 percentage of participants |
| G+E Standard Dose: Rash Grade < 2 | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | CR | 0.0 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | Missing (no response assessment) | 5.7 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | CR | 1.4 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | PR | 7.1 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | SD | 72.9 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | PD | 12.9 percentage of participants |
Secondary
Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization
Progression-free survival (PFS) as assessed from the point of randomization was defined as the time from randomization to the first occurrence of progressive disease (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause. For target lesions (TLs), PD was defined as at least a 20% increase in the sum of longest diameter (SLD) of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.
Time frame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| G+E Standard Dose: Rash Grade < 2 | Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization | 90.7 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization | 88.6 percentage of participants |
Secondary
Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In
PFS as assessed from the start of 4-week run-in was defined as the time from BL to the first occurrence of PD according to RECIST or death due to any cause. For TLs, PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.
Time frame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| G+E Standard Dose: Rash Grade < 2 | Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In | 90.6 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In | 90.7 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In | 88.6 percentage of participants |
Secondary
Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST
Disease control was defined as a participant with a response of CR or PR for at least 4 weeks at any time during treatment, or SD that was maintained for at least 8 weeks after the start of treatment. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Time frame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| G+E Standard Dose: Rash Grade < 2 | Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST | 62.7 percentage of participants |
| G+E Escalating Dose: Rash Grade < 2 | Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST | 47.1 percentage of participants |
p-value: 0.060395% CI: [-32.4, 1.3]Chi-squared
Secondary
PFS Assessed From Point of Randomization
PFS assessed from the point of randomization was defined as the median time, in weeks, from randomization to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.
Time frame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| G+E Standard Dose: Rash Grade < 2 | PFS Assessed From Point of Randomization | 19.4 weeks |
| G+E Escalating Dose: Rash Grade < 2 | PFS Assessed From Point of Randomization | 15.3 weeks |
p-value: 0.629895% CI: [0.77, 1.54]Log Rank
Secondary
PFS Assessed From the Start of 4-Week Run-In
PFS assessed from the start of 4-week run-in was defined as the median time, in weeks, from BL to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.
Time frame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.
Population: FAS; only participants with an event of PD or death were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| G+E Standard Dose: Rash Grade < 2 | PFS Assessed From the Start of 4-Week Run-In | 17.1 weeks |
| G+E Escalating Dose: Rash Grade < 2 | PFS Assessed From the Start of 4-Week Run-In | 23.4 weeks |
| G+E Escalating Dose: Rash Grade < 2 | PFS Assessed From the Start of 4-Week Run-In | 19.3 weeks |
p-value: 0.021795% CI: [0.51, 0.95]Log Rank
p-value: 0.159695% CI: [0.57, 1.1]Log Rank