Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Nintedanib

Protein Kinase Inhibitors

Enzyme Inhibitors

BIBF1120

Placebo

Boehringer Ingelheim

The primary objective of this study is to estimate the Progression Free Survival Rates (PFS) of patients with relapsed ovarian cancer after 9 months of continuous treatment with either BIBF 1120 or matching placebo.

A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer

The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.

The rate (probability) of being progression free at Week 12 and Week 24. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.

Time to Tumour Progression according to RECIST version 1.0 , CA-125 (ovarian tumour marker) levels and RECIST + CA-125 levels.

For CA-125, progressive disease was defined on the basis of progressive serial elevations of CA-125 according to the following criteria:

Patients with elevated CA-125 pre-treatment and normalisation of CA-125 had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart. or Patients with elevated CA-125 pre-treatment that never normalised had to show evidence of CA-125 levels ≥2 x the nadir value on 2 occasions at least 1 week apart. or Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart.

Composite (RECIST+CA-125) endpoint is the RECIST progressive disease (PD) if it occurred or the CA-125 PD if it occurred in the absence of RECIST PD.

This end point was not determined as no patients died during the trial.

Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).

Clinical Relevant Abnormalities for laboratory parameters. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.

Patients were treated with 250mg nintedanib twice daily.

Patients were treated with matching placebo twice daily.

Patients were treated with 250mg nintedanib twice daily

Patients were treated with matching placebo twice daily

Total

Age, Continuous

Sex: Female, Male

Treated set consist of all patients who received at least 1 dose of nintedanib or placebo.

Note: 43 patients were included in the analyses instead of 44 patients in nintedanib arm as one patient was excluded after drug administration due to important protocol violation.

Data from all randomised patients collected upto NOV'08 were included in all above sections,unless stated otherwise.5 patients continued on BIBF1120 after database lock(DBL)-NOV'08 upto Mar'14,but due to limited data no further analyses were done.

Boehringer Ingelheim Call Center

PFS Rate at 36 Weeks (After 9 Months)

at 24 weeks ( after 6 months)

at 12 weeks (after 3 months)

PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)

according to RECIST and CA-125

according to CA-125

according to RECIST

Time to Tumour Progression

This endpoint could not be calculated as no patients died.

Time to Death

CTCAE grade 1

CTCAE grade 2

CTCAE grade 3

CTCAE grade 4

CTCAE grade 5

Incidence and Intensity of Adverse Events With Grading According CTCAE

Alanine aminotransferase increased

Gamma-glutamyltransferase increased

Aspartate aminotransferase increased

Blood alkaline phosphatase increased

Blood lactate dehydrogenase increased

Blood alkaline phosphatase

Blood alkaline phosphatase abnormal

Lymphocyte count decreased

Vitamin B12 decreased

Alanine aminotransferase abnormal

Blood lactate dehydrogenase abnormal

Gamma-glutamyltransferase abnormal

Neutrophil count decreased

White blood cells urine positive

Blood pressure increased

Electrocardiogram T wave amplitude decreased

Liver function test abnormal

Clinical Relevant Abnormalities for Laboratory Parameters

Overall Study

Spots Global Cancer Trial Database for A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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