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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019437-97 | EudraCT Number | EudraCT |
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The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of the combination of BI 6727 with BIBW 2992, in patients with advanced or metastatic solid tumours. Dosages of both BI 6727 and BIBW 2992 will be varied to establish the MTD of the combination. Two combination treatment schedules will be tested, the MTD of each combination will be determined.
Secondary objectives are the exploration of pharmacokinetics, overall safety and preliminary efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| two experimental arms | Experimental | patients receive increasing doses of BI 6727 in combination with increasing doses of BIBW 2992 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 6727 + BIBW 2992 | Drug | BI 6727 administered i.v. every 21 days + BIBW 2992 given orally once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLT) | MTD was defined on the basis of DLTs occuring during Cycle 1 of the dose escalation part in each of the 2 treatment schedules. DLTs were defined as drug related based on Common Terminology Criteria for AE's (CTCAE) Grade(G) :1) G4 neutropenia (ANC, including bands, <500/mm³) for more than 7 days, 2) G3 or 4 neutropenia associated with fever >38.5° C (febrile neutropenia),3) Neutropenic infection G ≥3, 4) G4 thrombocytopenia or G3 thrombocytopenia associated with bleeding requiring whole blood transfusion.5) Non-haematological G ≥3 toxicity excluding: (a) untreated G3 diarrhoea, (b) untreated G3 nausea and/or vomiting, (c) untreated G3 rash. 6) G2 increase in AST and/or ALT in conjunction with an elevated bilirubin level of G ≥2, 7) G2 nausea and/or vomiting despite optimal supportive/antiemetic treatment for at least 7consecutive days. 8) G2 diarrhoea for 2 or more consecutive days despite antidiarrhoeal medication/hydration, 9) Decrease in left ventricular function G ≥2. | 22 Days |
| Maximum Tolerable Dose (MTD) of Two Combination Therapy of Volasertib and Afatinib. | Maximum Tolerable Dose (MTD) was determined by dose escalation for volasertib and afatinib. The "3 + 3 design with de-escalation" for both the Schedules A and B. Patients were sequentially allocated to the dose cohorts. Apart from allocation to the treatment schedules, escalation and/or de-escalation to determine the MTD occurred independently within the 2 dose schedules. Cohorts of 3 patients were to be treated at the starting dose levels according to the treatment schedule. Before entering patients at a higher dose level, all patients at the previous dose level combination had to complete at least the initial cycle of 21 days. | MTD was assessed during the first cycle of combination of Volasertib and Afatinib therapy (22 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Drug-related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) Criteria v 3.0 | Number of patients with investigator defined drug-related adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria v 3.0 | After the first drug administration until 28 days after the last drug administration, up to 413 days. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1230.20.32001 Boehringer Ingelheim Investigational Site | Brussels | Belgium | ||||
| 1230.20.32003 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26349473 | Derived | Machiels JP, Peeters M, Herremans C, Surmont V, Specenier P, De Smet M, Pilz K, Strelkowa N, Liu D, Rottey S. A phase I study of volasertib combined with afatinib, in advanced solid tumors. Cancer Chemother Pharmacol. 2015 Oct;76(4):843-51. doi: 10.1007/s00280-015-2860-2. Epub 2015 Sep 8. |
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This is a Phase 1, open label, non randomised and dose escalation trial. There was no control group. The Combination of Volasertib and Afatinib to be investigated in two treatment schedules (A & B). In Schedule B the starting doses will be depend on the outcome of the MTD determination from treatment schedule A.
Aspartate amino transferase (AST) ; Alanine amino transferase (ALT) and Eastern Cooperative Oncology Group (ECOG).
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| ID | Title | Description |
|---|---|---|
| FG000 | Volasertib150 mg+Afatinib 30 mg (Schedule A) | Schedule A : Volasertib (Vol) 150 mg on Day 1 and afatinib (aftb) 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Number of Patients With Objective Response (OR) | Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR). As Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by using appropriate radiology techniques: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. | Tumor assessment was performed at screening and at the end of every 3 treatment cycle (ie every 9 weeks of treatment). |
| Number of Patients With Best Overall Response. | Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response, partial response, stable disease, progressive disease or not evaluable. As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by using appropriate radiology techniques: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. | Tumor assessment was performed at screening and at the end of every 3 treatment cycle (ie every 9 weeks of treatment). |
| Number of Patients With Disease Control | Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Patients who had a best overall tumour response of complete response (CR), partial response (PR) or stable disease (SD) were assessed to show disease control. As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by using appropriate radiology techniques: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. | Tumor assessment was performed at screening and at the end of every 3 treatment cycle (ie every 9 weeks of treatment). |
| Edegem |
| Belgium |
| 1230.20.32002 Boehringer Ingelheim Investigational Site | Ghent | Belgium |
| FG001 | Volasertib 225 mg+Afatinib 30 mg (Schedule A) | Schedule A : Volasertib 225 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| FG002 | Volasertib 300 mg+Afatinib 30 mg (Schedule A) | Schedule A :Volasertib 300 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| FG003 | Volasertib 300 mg+Afatinib 40 mg (Schedule A) | Schedule A :Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| FG004 | Volasertib 300 mg+Afatinib 50 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 50 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| FG005 | Volasertib 300 mg+Afatinib 70 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 70 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| FG006 | Volasertib 300 mg+Afatinib 90 mg (Schedule B) | Schedule B : Volasertib 300 mg on Day 1 and afatinib 90 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated Set (TS): All 57 patients who received at least 1 dose of volasertib and afatinib were included in the treated set
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| ID | Title | Description |
|---|---|---|
| BG000 | Volasertib150 mg+Afatinib 30 mg (Schedule A) | Schedule A : Volasertib (Vol) 150 mg on Day 1 and afatinib (aftb) 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| BG001 | Volasertib 225 mg+Afatinib 30 mg (Schedule A) | Schedule A : Volasertib 225 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| BG002 | Volasertib 300 mg+Afatinib 30 mg (Schedule A) | Schedule A : Volasertib 300 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| BG003 | Volasertib 300 mg+Afatinib 40 mg (Schedule A) | Schedule A : Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| BG004 | Volasertib 300 mg+Afatinib 50 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 50 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| BG005 | Volasertib 300 mg+Afatinib 70 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 70 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| BG006 | Volasertib 300 mg+Afatinib 90 mg (Schedule B) | Schedule B : Volasertib 300 mg on Day 1 and afatinib 90 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| ECOG at screening | the Eastern Cooperative Oncology Group (ECOG) performance score was between 0 and 2. 0: Normal activity. Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; | Count of Participants | Participants |
| |||||||||||||||
| Tumour classification | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLT) | MTD was defined on the basis of DLTs occuring during Cycle 1 of the dose escalation part in each of the 2 treatment schedules. DLTs were defined as drug related based on Common Terminology Criteria for AE's (CTCAE) Grade(G) :1) G4 neutropenia (ANC, including bands, <500/mm³) for more than 7 days, 2) G3 or 4 neutropenia associated with fever >38.5° C (febrile neutropenia),3) Neutropenic infection G ≥3, 4) G4 thrombocytopenia or G3 thrombocytopenia associated with bleeding requiring whole blood transfusion.5) Non-haematological G ≥3 toxicity excluding: (a) untreated G3 diarrhoea, (b) untreated G3 nausea and/or vomiting, (c) untreated G3 rash. 6) G2 increase in AST and/or ALT in conjunction with an elevated bilirubin level of G ≥2, 7) G2 nausea and/or vomiting despite optimal supportive/antiemetic treatment for at least 7consecutive days. 8) G2 diarrhoea for 2 or more consecutive days despite antidiarrhoeal medication/hydration, 9) Decrease in left ventricular function G ≥2. | Treated Set (TS) | Posted | Number | participants | 22 Days |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Tolerable Dose (MTD) of Two Combination Therapy of Volasertib and Afatinib. | Maximum Tolerable Dose (MTD) was determined by dose escalation for volasertib and afatinib. The "3 + 3 design with de-escalation" for both the Schedules A and B. Patients were sequentially allocated to the dose cohorts. Apart from allocation to the treatment schedules, escalation and/or de-escalation to determine the MTD occurred independently within the 2 dose schedules. Cohorts of 3 patients were to be treated at the starting dose levels according to the treatment schedule. Before entering patients at a higher dose level, all patients at the previous dose level combination had to complete at least the initial cycle of 21 days. | Treated Set (TS) | Posted | Number | mg | MTD was assessed during the first cycle of combination of Volasertib and Afatinib therapy (22 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Drug-related Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) Criteria v 3.0 | Number of patients with investigator defined drug-related adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria v 3.0 | Treated Set (TS) | Posted | Number | participants | After the first drug administration until 28 days after the last drug administration, up to 413 days. |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Objective Response (OR) | Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR). As Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by using appropriate radiology techniques: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. | Treated Set (TS) | Posted | Number | participants | Tumor assessment was performed at screening and at the end of every 3 treatment cycle (ie every 9 weeks of treatment). |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Best Overall Response. | Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response, partial response, stable disease, progressive disease or not evaluable. As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by using appropriate radiology techniques: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. | Treated Set (TS) | Posted | Number | participants | Tumor assessment was performed at screening and at the end of every 3 treatment cycle (ie every 9 weeks of treatment). |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Disease Control | Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Patients who had a best overall tumour response of complete response (CR), partial response (PR) or stable disease (SD) were assessed to show disease control. As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by using appropriate radiology techniques: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. | Treated Set (TS) | Posted | Number | participants | Tumor assessment was performed at screening and at the end of every 3 treatment cycle (ie every 9 weeks of treatment). |
|
After the first drug administration until 28 days after the last drug administration, upto 413 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Volasertib150 mg+Afatinib 30 mg (Schedule A) | Schedule A : Volasertib (Vol) 150 mg on Day 1 and afatinib (aftb) 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. | 0 | 3 | 3 | 3 | ||
| EG001 | Volasertib 225 mg+Afatinib 30 mg (Schedule A) | Schedule A : Volasertib 225 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. | 0 | 3 | 3 | 3 | ||
| EG002 | Volasertib 300 mg+Afatinib 30 mg (Schedule A) | Schedule A : Volasertib 300 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. | 11 | 20 | 18 | 20 | ||
| EG003 | Volasertib 300 mg+Afatinib 40 mg (Schedule A) | Schedule A : Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. | 2 | 3 | 3 | 3 | ||
| EG004 | Volasertib 300 mg+Afatinib 50 mg (Schedule B) | Schedule B : Volasertib 300 mg on Day 1 and afatinib 50 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. | 1 | 3 | 3 | 3 | ||
| EG005 | Volasertib 300 mg+Afatinib 70 mg (Schedule B) | Schedule B : Volasertib 300 mg on Day 1 and afatinib 70 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. | 12 | 19 | 19 | 19 | ||
| EG006 | Volasertib 300 mg+Afatinib 90 mg (Schedule B) | Schedule B : Volasertib 300 mg on Day 1 and afatinib 90 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. | 3 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Mucosal haemorrhage | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Puncture site infection | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 15.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 15.1 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 15.1 | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 15.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Eyelids pruritus | Eye disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Anal ulcer | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Faeces pale | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Perianal erythema | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Salivary gland enlargement | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Feeling cold | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Hernia | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Oedema | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Pain | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Xerosis | General disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Haemorrhagic hepatic cyst | Hepatobiliary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MEDDRA 15.1 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MEDDRA 15.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MEDDRA 15.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MEDDRA 15.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MEDDRA 15.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MEDDRA 15.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MEDDRA 15.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MEDDRA 15.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MEDDRA 15.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MEDDRA 15.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA 15.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MEDDRA 15.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 15.1 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Bladder irritation | Renal and urinary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Renal vein thrombosis | Renal and urinary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Vaginal inflammation | Reproductive system and breast disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Vasoconstriction | Vascular disorders | MEDDRA 15.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C541363 | BI 6727 |
| D000077716 | Afatinib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| 1 |
|
| 2 |
|
| Non small cell lung |
|
| Gastrointest. tract |
|
| Colorectal (col/rec) |
|
| Anal region |
|
| Pancreas |
|
| Biliary tree |
|
| Genitourinary system |
|
| Ureter |
|
| Gynecologic cancers |
|
| Cancers of breast |
|
| Soft tissue/oss sarc |
|
| Other |
|
| Missing |
|
| OG005 | Volasertib 300 mg+Afatinib 70 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 70 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG006 | Volasertib 300 mg+Afatinib 90 mg (Schedule B) | Schedule B : Volasertib 300 mg on Day 1 and afatinib 90 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG001 | Volasertib in Combination With Afatinib (Schedule B) | The combination of Volasertib and Afatinib were investigated in two treatment schedules (A & B). In schedule B , Dose level 1: Volasertib 300 mg and afatinib 50 mg. Dose level 2: Volasertib 300 mg and afatinib 70 mg. Dose level 3: Volasertib 300 mg and afatinib 90mg. |
|
|
| Volasertib 300 mg+Afatinib 30 mg (Schedule A) |
Schedule A : Volasertib 300 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG003 | Volasertib 300 mg+Afatinib 40 mg (Schedule A) | Schedule A : Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG004 | Volasertib 300 mg+Afatinib 50 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 50 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG005 | Volasertib 300 mg+Afatinib 70 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 70 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG006 | Volasertib 300 mg+Afatinib 90 mg (Schedule B) | Schedule B : Volasertib 300 mg on Day 1 and afatinib 90 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
|
|
| OG002 | Volasertib 300 mg+Afatinib 30 mg (Schedule A) | Schedule A : Volasertib 300 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG003 | Volasertib 300 mg+Afatinib 40 mg (Schedule A) | Schedule A : Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG004 | Volasertib 300 mg+Afatinib 50 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 50 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG005 | Volasertib 300 mg+Afatinib 70 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 70 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG006 | Volasertib 300 mg+Afatinib 90 mg (Schedule B) | Schedule B : Volasertib 300 mg on Day 1 and afatinib 90 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
|
|
Schedule A : Volasertib 225 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG002 | Volasertib 300 mg+Afatinib 30 mg (Schedule A) | Schedule A : Volasertib 300 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG003 | Volasertib 300 mg+Afatinib 40 mg (Schedule A) | Schedule A (Cycle 1):Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG004 | Volasertib 300 mg+Afatinib 50 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 50 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG005 | Volasertib 300 mg+Afatinib 70 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 70 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG006 | Volasertib 300 mg+Afatinib 90 mg (Schedule B) | Schedule B : Volasertib 300 mg on Day 1 and afatinib 90 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
|
|
| OG002 | Volasertib 300 mg+Afatinib 30 mg (Schedule A) | Schedule A : Volasertib 300 mg on Day 1 and afatinib 30 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG003 | Volasertib 300 mg+Afatinib 40 mg (Schedule A) | Schedule A : Volasertib 300 mg on Day 1 and afatinib 40 mg from Day 2 to Day 21. Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG004 | Volasertib 300 mg+Afatinib 50 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 50 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG005 | Volasertib 300 mg+Afatinib 70 mg (Schedule B) | Schedule B: Volasertib 300 mg on Day 1 and afatinib 70 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
| OG006 | Volasertib 300 mg+Afatinib 90 mg (Schedule B) | Schedule B : Volasertib 300 mg on Day 1 and afatinib 90 mg pulsed from Day 2 to Day 6 (no administration of afatinib from Day 7 to 21). Cycle 1 was completed after 21 days on Day 22. All subsequent cycles lasted 21 days. Patients that started a second cycle were to be co-administered with volasertib and afatinib on Day 1 of the second cycle. Afatinib was to be taken before the start of the volasertib infusion. |
|
|