Trial Outcomes & Findings for Dose Escalation Study of BIBF 1120 in Combination With Carboplatin and PLD in Relapsed Ovarian Cancer (OC) (NCT NCT01329549)
NCT ID: NCT01329549
Last Updated: 2014-11-27
Results Overview
to determine the MTD of nintedanib in combination with carboplatin (AUC 5 mg/mL·min) and PLD (30 mg/m2) reflected by the number of DLTs per dose level. This endpoint has not been statistically analyzed in the study report.
TERMINATED
PHASE1
2 participants
28 days
2014-11-27
Participant Flow
Participant milestones
| Measure |
Nintedanib (150 mg) + Carboplatin + PLD
Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL\*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Nintedanib (150 mg) + Carboplatin + PLD
Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL\*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Dose Escalation Study of BIBF 1120 in Combination With Carboplatin and PLD in Relapsed Ovarian Cancer (OC)
Baseline characteristics by cohort
| Measure |
Nintedanib (150 mg) + Carboplatin + PLD
n=2 Participants
Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL\*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
|
|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Treated set
to determine the MTD of nintedanib in combination with carboplatin (AUC 5 mg/mL·min) and PLD (30 mg/m2) reflected by the number of DLTs per dose level. This endpoint has not been statistically analyzed in the study report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0.5h after the start of the infusion up to 56 daysPopulation: Treated set
Cmax was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). This endpoint has not been statistically analyzed in the study report. Detailed outcome measure time frame: total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2 free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2 PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2 nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0.5h after the start of the infusion up to 56 daysPopulation: Treated set
AUC0-tz was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report. Detailed outcome measure time frame: total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2 free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2 PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2 nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0.5h after the start of the infusion up to 56 daysPopulation: Treated set
AUC0-∞ was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report. Detailed outcome measure time frame total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2 free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2 PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2 nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0.5h after the start of the infusion up to 56 daysPopulation: Treated set
tmax was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report. Detailed outcome measure time frame: total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2 free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2 PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2 nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0.5h after the start of the infusion up to 56 daysPopulation: Treated set
t1/2 was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report. Detailed outcome measure time frame: total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2 free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2 PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2 nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0.5h after the start of the infusion up to 56 daysPopulation: Treated set
CL was evaluated for doxorubicin, free platinum, total platinum. Descriptive statistics were not calculated in the study report. Detailed outcome measure time frame: total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2 free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2 PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0.5h after the start of the infusion up to 56 daysPopulation: Treated set
Vss was evaluated for doxorubicin, free platinum, total platinum. Descriptive statistics were not calculated in the study report. total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2 free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2 PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2
Outcome measures
Outcome data not reported
Adverse Events
Nintedanib (150 mg) + Carboplatin + PLD
Serious adverse events
| Measure |
Nintedanib (150 mg) + Carboplatin + PLD
n=2 participants at risk
Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL\*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Injury, poisoning and procedural complications
Fracture
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
Other adverse events
| Measure |
Nintedanib (150 mg) + Carboplatin + PLD
n=2 participants at risk
Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL\*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
2/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
2/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
2/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Gastrointestinal disorders
Cheilitis
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Gastrointestinal disorders
Gingival pain
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
General disorders
Fatigue
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
General disorders
Pyrexia
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Investigations
Neutrophil count decreased
|
100.0%
2/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Investigations
Platelet count decreased
|
100.0%
2/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Investigations
White blood cell count decreased
|
100.0%
2/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Investigations
Blood alkaline phosphatase increased
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Investigations
Weight decreased
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Investigations
Weight increased
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Injury, poisoning and procedural complications
Fall
|
100.0%
2/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
|
Injury, poisoning and procedural complications
Fracture
|
50.0%
1/2 • From first administration of study treatment up to 33 days after the last administration of the study treatment, up to 360 days.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER