A Phase 2 interventional study of BIBW 2992 and Cetuximab in Colorectal Neoplasms, sponsored by Boehringer Ingelheim. Completed at 13 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-26.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 94 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Patients receive BIBW 2992 tablets once daily
Drug: BIBW 2992
Patients receive cetuximab intravenously once a week, every week
Drug: Cetuximab
Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management
Patients receive cetuximab intravenously, once a week, every week
Percentage of Participants With Objective Response
Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied.
Time frame: Baseline till progression or death, whichever came first, assessed up to 23 months
Percentage of Participants With Disease Control (DC)
Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.
Time frame: Baseline till progression or death, whichever came first, assessed up to 23 months
Progression Free Survival (PFS)
PFS time is defined as time from randomisation (wild-type group) or start of treatment (mutated group) to tumor progression evaluated according to RECIST (version 1.1) or death whichever occurs earlier. Median and confidence interval estimated using product-limit Kaplan-Meier method.
Time frame: Baseline till progression or death, whichever came first, assessed up to 23 months
Overall Survival (OS) Time
OS time is defined as time from the date of randomisation (wild-type group) or date of start of treatment (mutated group) to the date of death. Median and confidence interval estimated using product-limit Kaplan-Meier method.
Time frame: Baseline till death, assessed up to 23 months
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)
Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.
Time frame: day 8
| Milestone | Afatinib (Wild-type) | Cetuximab (Wild-type) | Afatinib (Mutated) |
|---|---|---|---|
| Started | 36 | 15 | 43 |
| Completed | 0 | 0 | 0 |
| Not completed | 36 | 15 | 43 |
| Withdrew: Other adverse event | 8 | 1 | 7 |
| Withdrew: Not treated | 0 | 1 | 2 |
| Withdrew: Progressive disease | 27 | 13 | 32 |
| Withdrew: Refusal to continue taking trial medicat | 1 | 0 | 2 |
Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied.
| Percentage of Participants | Afatinib (Wild-type) | Cetuximab (Wild-type) |
|---|---|---|
| Percentage of Participants With Objective Response | 3 | 20 |
Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.
| Percentage of Participants | Afatinib (Mutated) |
|---|---|
| Percentage of Participants With Disease Control (DC) | 12 (4.9 to 23.9) |
PFS time is defined as time from randomisation (wild-type group) or start of treatment (mutated group) to tumor progression evaluated according to RECIST (version 1.1) or death whichever occurs earlier. Median and confidence interval estimated using product-limit Kaplan-Meier method.
| Days | Afatinib (Wild-type) | Cetuximab (Wild-type) | Afatinib (Mutated) |
|---|---|---|---|
| Progression Free Survival (PFS) | 46.0 (43.0 to 49.0) | 144.5 (24.0 to 233.0) | 41.0 (39.0 to 46.0) |
OS time is defined as time from the date of randomisation (wild-type group) or date of start of treatment (mutated group) to the date of death. Median and confidence interval estimated using product-limit Kaplan-Meier method.
| Days | Afatinib (Wild-type) | Cetuximab (Wild-type) | Afatinib (Mutated) |
|---|---|---|---|
| Overall Survival (OS) Time | 355.0 (211.0 to 449.0) | NA (204.0 to NA) | 173.0 (106.0 to 214.0) |
Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.
| ng/mL | Afatinib (Wild-type) | Afatinib (Mutated) |
|---|---|---|
| Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8) | 16.6 ± 80.3 | 21.4 ± 91.0 |
Collected over First administration of trial medication until 28 days after last administration of trial medication. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Afatinib (Wild-type) | — | 15/36 (41.7%) | 35/36 (97.2%) |
| Cetuximab (Wild-type) | — | 5/14 (35.7%) | 14/14 (100%) |
| Afatinib (Mutated) | — | 18/41 (43.9%) | 40/41 (97.6%) |
| Event | Afatinib (Wild-type) | Cetuximab (Wild-type) | Afatinib (Mutated) |
|---|---|---|---|
| Bile duct obstructionHepatobiliary disorders | 0/36 | 2/14 | 1/41 |
| VomitingGastrointestinal disorders | 5/36 | 1/14 | 3/41 |
| NauseaGastrointestinal disorders | 4/36 | 0/14 | 5/41 |
| DiarrhoeaGastrointestinal disorders | 4/36 | 0/14 | 4/41 |
| Disease progressionGeneral disorders | 1/36 | 0/14 | 4/41 |
| Abdominal pain upperGastrointestinal disorders | 0/36 | 1/14 | 1/41 |
| ConstipationGastrointestinal disorders | 0/36 | 1/14 | 2/41 |
| Small intestinal obstructionGastrointestinal disorders | 1/36 | 1/14 | 0/41 |
| FatigueGeneral disorders | 1/36 | 1/14 | 1/41 |
| MalaiseGeneral disorders | 0/36 | 1/14 | 0/41 |
| Event | Afatinib (Wild-type) | Cetuximab (Wild-type) | Afatinib (Mutated) |
|---|---|---|---|
| RashSkin and subcutaneous tissue disorders | 19/36 | 10/14 | 25/41 |
| DiarrhoeaGastrointestinal disorders | 25/36 | 4/14 | 25/41 |
| Decreased appetiteMetabolism and nutrition disorders | 11/36 | 6/14 | 13/41 |
| NauseaGastrointestinal disorders | 12/36 | 3/14 | 17/41 |
| FatigueGeneral disorders | 12/36 | 3/14 | 15/41 |
| VomitingGastrointestinal disorders | 6/36 | 2/14 | 14/41 |
| ConstipationGastrointestinal disorders | 10/36 | 4/14 | 4/41 |
| HypomagnesaemiaMetabolism and nutrition disorders | 1/36 | 4/14 | 0/41 |
| HeadacheNervous system disorders | 2/36 | 4/14 | 4/41 |
| Abdominal painGastrointestinal disorders | 2/36 | 3/14 | 7/41 |
Treated set.
| Age, Continuous(years) | Afatinib (Wild-type) | Cetuximab (Wild-type) | Afatinib (Mutated) | Total |
|---|---|---|---|---|
| Mean | 62.5 ± 10.4 | 62.6 ± 7.7 | 60.0 ± 11.9 | 61.4 ± 10.8 |
| Sex: Female, Male(Participants) | Afatinib (Wild-type) | Cetuximab (Wild-type) | Afatinib (Mutated) | Total |
|---|---|---|---|---|
| Female | 9 | 5 | 22 | 36 |
| Male | 27 | 9 | 19 | 55 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim