Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent

NCT02568449 | Completed Phase 2 Results DMC

• 4 other identifiers: 2015-010NCI-2015-014121506014121P30CA022453
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

This phase II trial studies how well nintedanib works in treating patients with malignant pleural mesothelioma that has come back. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Recurrent Pleural Malignant Mesothelioma; Stage IV Pleural Mesothelioma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).

  From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 4 months

Secondary Outcomes (3)

• Incidence of Grade 3-4 Toxicity

  Up to 1 year

• Overall Survival

  Up to 1 year

• Number of Participants Responded (Complete Response, Partial Response, Stable Disease, Progressive Disease, Not Evaluable)

  Up to 1 year

Study Arms (1)

Treatment (nintedanib)

EXPERIMENTAL

Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Nintedanib

Interventions

Nintedanib DRUG

Given PO

Also known as: BIBF 1120, BIBF-1120, Intedanib, Multitargeted Tyrosine Kinase Inhibitor BIBF 1120, tyrosine kinase inhibitor BIBF 1120, Vargatef

Treatment (nintedanib)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed diagnosis of unresectable malignant pleural mesothelioma
• Patients must have measurable or non-measurable disease documented by computed tomography (CT) scan; measurable disease must be assessed within 28 days prior to registration; non-measurable disease must be assessed within 42 days prior to registration; the CT from a combined positron emission tomography (PET)/CT must not be used to document measurable disease unless it is of diagnostic quality; all disease must be assessed by RECIST and modified RECIST criteria
• Patients must have had prior systemically administered platinum-based chemotherapy; pleural space washing with cisplatin does not constitute systemic administration; no more than two prior systemic therapeutic regimens are allowed (including biologics, targeted and immunotherapies), and at least one regimen must have been platinum-based; neoadjuvant and/or adjuvant systemic therapy will not be counted as a prior regimen, assuming at least 12 weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease; patients must have completed systemic therapy (including any chemotherapy, biologics, targeted and immunotherapies) \>= 28 days (42 days for nitrosoureas or mitomycin C) prior to registration and have recovered from adverse events due to agents administered
• No prior treatment with BIBF 1120 or any other vascular endothelial growth factor receptor (VEGFR) inhibitor
• No known hypersensitivity to BIBF 1120, to its excipients or to contrast media
• Patients may have received prior surgery (e.g., pleurectomy) provided that at least 28 days have elapsed since surgery (thoracic or other major surgeries) and patients have recovered from all associated toxicities at the time of registration; there must be no anticipated need for major surgical procedures during protocol treatment
• No active brain metastases (e.g. stable for \< 4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomization); no leptomeningeal disease
• No radiographic evidence of cavitary or necrotic tumors
• No centrally located tumors with radiographic evidence (CT or magnetic resonance imaging \[MRI\]) of local invasion of major blood vessels
• Institutions must offer patients the opportunity to submit tissue for future correlative studies
• Patients may have received prior radiation therapy provided that at least 14 days have elapsed since the last treatment and patients have recovered from all associated toxicities at the time of registration
• Patients must have a Zubrod performance status of 0-1
• Absolute neutrophil count (ANC) \>= 1,500/mcl
• Platelet count \>= 100,000/mcl
• Serum bilirubin =\< institutional upper limit of normal (IULN)

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Dipesh Uprety
• Organization: Karmanos Cancer Instiute

upretyd@karmanos.org

313-576-8722

Study Officials

• Dipesh Uprety, M.D.

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 5, 2015
• Study Start: March 15, 2016
• Primary Completion: January 1, 2017
• Study Completion: June 26, 2018
• Last Updated: December 9, 2021
• Results First Posted: December 9, 2021

Record last verified: 2021-11

Locations

US (3)