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

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Recurrence

Small Cell Lung Carcinoma

Lung Neoplasms

Hypersensitivity

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

BIBF1120 is a VEGFR, FGFR and PDGFR inhibitor

Quincy Chu, MD

This study is being done to evaluate the good and bad effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients and to see if BIBF1120 may or may not be more effective and better tolerated than standard therapy.

The purpose of this study is to:

* Find out the proportion of patients with their small small cell lung cancer controlled for at least 90 days after treatment with BIBF1120
* Compare the response rate, survival and side effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients
* Identify a group of patients who will benefit the most from BIBF1120 In this study, patients will receive BIBF1120 at 200 mg twice daily continuously. A cycle will be 21 days. During treatment, the dose of BIBF1120 will be held or reduced to lower doses if patients do not tolerate it well or if the doctors are concerned about the side effects of BIBF1120 on individual patients.

This study is being done to evaluate the effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients.

Primary Objectives:

* To investigate the efficacy and safety of a novel VEGFR-2 and FGFR-1 targeting agent, BIBF1120, in previously treated, platinum-sensitive small cell lung cancer patients.

Secondary Objectives:

* To correlate response to the apoptotic biomarkers, Bcl-XL/Bcl-2 and FDGR-1 amplification.
* To correlate response with baseline FLT-PET SUV uptake and change in FLT-PET SUV uptake.

All eligible patients will be treated with 200 mg bid of BIBF1120 daily and 21 days will be considered as one cycle

A Study to Evaluate the Good and Bad Effects of BIBF1120 in Small Cell Lung Cancer Patients Who Have Previously Benefited From First-line Platinum-based Chemotherapy

A Phase II Study of BIBF1120 in Recurrent and Platinum-Sensitive Small Cell Lung Cancer (SCLC)

Cross Cancer Institute

AHS Cancer Control Alberta

Glioblastoma

Disease Attributes

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Tablet 200 mg twice daily until progression

VEGF inhibition by BEV may induce a change in tumor invasiveness and treatment failure is often associated with remote metastases. BEV may stop the growth of tumor cells by blocking blood flow to the tumor. Cediranib, a pan-VEGF inhibitor has shown promising results in recurrent GBM.

VEGF-blocking with small molecules may overcome the mechanism of resistance, and response to BIBF-1120 in such circumstances may open a new treatment option in GBM. In additional, recurrent glioblastomas have an extremely poor prognosis, so innovative therapies are needed.

BIBF 1120 in Recurrent Glioblastoma Multiforme

Phase II Study of BIBF 1120 in Recurrent Glioblastoma Multiforme

University of Copenhagen

Ulrik Lassen

Ulrik Lassen, MD, PH.D

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Transitional Cell Carcinoma

BIBF 1120 in patients with advanced FGFR3 mutated

BIBF 1120 in patients with advanced FGFR3 overexpressed

BIBF 1120 in patients with advanced FGFR3 wild type

Chia-Chi Lin, Ph.D

BIBF1120 in patients with advanced FGFR3 mutated, FGFR3 overexpressed, or FGFR3 wild type urothelial carcinoma of urinary bladder, urethra, ureter, and renal pelvis and who have failed platinum-based chemotherapy.

BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma

A Phase II Trial of BIBF1120 in Patients With Advanced FGFR3 Mutated, FGFR3 Overexpressed, or FGFR3 Wild Type Urothelial Carcinoma of Urinary Bladder, Urethra, Ureter, and Renal Pelvis and Who Have Failed Platinum-based Chemotherapy

To define the response rate of BIBF1120 in patients with advanced FGFR3-mutated,overexpressed,wild type UC and who have failed platinum-based chemotherapy.

National Taiwan University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer	NCT00710762	Ovarian Neoplas...	BIBF1120 Placebo	18 Years -	Boehringer Ingelheim
A Study to Evaluate the Good and Bad Effects of BIBF1120 in Small Cell Lung Cancer Patients Who Have Previously Benefited From First-line Platinum-based Chemotherapy	NCT02152059	Small Cell Lung... Platinum-sensit...	BIBF1120	18 Years -	AHS Cancer Control Alberta
BIBF 1120 in Recurrent Glioblastoma Multiforme	NCT01251484	Recurrent Gliob...	BIBF1120	18 Years -	Rigshospitalet, Denmark
A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer	NCT00710762	Ovarian Neoplas...	BIBF1120 Placebo	18 Years -	Boehringer Ingelheim
BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma	NCT02278978	Urothelial Carc...	BIBF1120	20 Years -	National Taiwan University Hospital
A Study to Evaluate the Good and Bad Effects of BIBF1120 in Small Cell Lung Cancer Patients Who Have Previously Benefited From First-line Platinum-based Chemotherapy	NCT02152059	Small Cell Lung... Platinum-sensit...	BIBF1120	18 Years -	AHS Cancer Control Alberta

Spots Global Cancer Trial Database for bibf1120

Every month we try and update this database with for bibf1120 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bibf1120

Every month we try and update this database with for bibf1120 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bibf1120 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.