An Dose Escalation Study of Treatment With BIBF 1120 in Patients With Advanced Solid Tumours

NCT02182206 | Completed Phase 1

• 1 other identifier: 1199.3
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Maximum Tolerated Dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamic parameters (Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI))

Conditions

Tumors

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD) of BIBF 1120

  Up to 7 months

• Incidence and intensity of Adverse Events according to common toxicity criteria (CTC) associated with increasing doses of BIBF 1120

  Up to 7 months

Secondary Outcomes (35)

• Transfer constant (Ktrans)

  Screening, day 2, 28 and 56

• Extravascular-extracellular leakage volume (ve)

  Screening, day 2, 28 and 56

• Area under the gadolinium concentration time curve [0-60 seconds] (AUC[Gd])

  Screening, day 2, 28 and 56

• Relative blood volume (rBV)

  Screening, day 2, 28 and 56

• Mean transit time (MTT)

  Screening, day 2, 28 and 56

Study Arms (1)

BIBF 1120

EXPERIMENTAL

Drug: BIBF 1120

Interventions

BIBF 1120 DRUG

BIBF 1120

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who were not amenable to established forms of treatment
• Measurable tumour deposits by one or more techniques (X-ray), Computed Tomography (CT), Magnetic Resonance Imaging (MRI))
• At least one tumour lesion considered suitable for DCE-MRI as determined by discussion with centre radiologist. This lesion must not have been previously irradiated
• Age 18 years or older
• Life expectancy of at least three months
• Written informed consent given consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
• Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
• Patients completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies

You may not qualify if:

• Surgical procedures within four weeks of initiating treatment with the study drug, active ulcers, or injuries with incomplete wound healing
• Active infectious disease
• Uncontrolled, severe hypertension (diastolic BP (Blood Pressure) \>100 mmHg, Systolic BP\>180 mmHg)
• Gastrointestinal disorders that might have interfered with the resorption of the study drug
• Serious illness or concomitant non-oncological disease considered by the investigator to have been incompatible with the protocol
• Brain metastases requiring therapy
• Absolute neutrophil count less than 1500/mm3
• Platelet count less than 100 000/mm3
• Bilirubin greater than 1.5 mg/dl (\>26 μmol/L, System International (SI) unit equivalent)
• Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
• Serum creatinine greater than 1.5 mg/dl (\>132μmol/L, SI unit equivalent)
• Women and men who were sexually active and unwilling to use a medically acceptable method of contraception
• Pregnancy or breastfeeding
• Treatment with other investigational drugs; chemotherapy or hormone therapy (excluding Lutenizing Hormone Releasing Hormone (LHRH) agonists or bisphosphonates provided the lesion for MR (magnetic resonance) imaging did not arise from bone) or participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
• Patients unable to comply with the protocol

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Publications (1)

• Lee CP, Taylor NJ, Attard G, Pacey S, Nathan PD, de Bono JS, Temple G, Bell S, Stefanic M, Stopfer P, Tang A, Koh DM, Collins DJ, d'Arcy J, Padhani AR, Leach MO, Judson IR, Rustin GJ. Phase I study of nintedanib incorporating dynamic contrast-enhanced magnetic resonance imaging in patients with advanced solid tumors. Oncologist. 2015 Apr;20(4):368-9. doi: 10.1634/theoncologist.2014-0250. Epub 2015 Mar 20.

  PMID: 25795637 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

nintedanib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: June 1, 2003
• Primary Completion: June 1, 2005
• Last Updated: July 18, 2014

Record last verified: 2014-07