BAY 1000394 for MCL-1-, MYC-, and CCNE1-Amplified Tumors

NCT02656849 | Withdrawn Phase 2 DMC

• 1 other identifier: 15-380
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying whether a new experimental cancer study drug BAY 1000394 will be helpful in treating solid tumor cancer with an abnormality in one of the following genes: Mcl-1, Myc or CCNE.

Conditions

Solid Tumor

Keywords

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Six-month progression-free survival rate

  RECIST 1.1

  six months

Secondary Outcomes (5)

• Response Rate Mcl1-amplified tumors

  six months

• Response Rate MYC-amplified tumors

  six months

• Response Rate CCNE1-amplified tumors

  six months

• Overall Survival

  six months

• Time to Progression

  six months

Study Arms (1)

BAY 1000394

EXPERIMENTAL

After the screening procedures confirm eligibility to participate in the research study: * Each treatment cycle lasts 4 weeks. * Participants will take the study drug orally at predetermined times and dosage per cycle.

Drug: BAY 1000394

Interventions

BAY 1000394 DRUG

Also known as: Roniciclib

BAY 1000394

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 advanced cancer for which no curative therapy exists and have a malignancy which matches one of the following cohorts:
• MCL1 amplification (≥ 3 fold);
• MYC amplification (≥ 6 fold);
• CCNE1 amplification (≥ 6 fold).
• Molecular abnormalities may be detected by any CLIA-certified test, including Massive Parallel (Next-Generation) sequencing platforms.
• Patients must have measurable disease as defined by RECIST 1.1 criteria. In selected cases patients with evaluable disease may be eligible after discussion between the PI and Bayer.
• Participants must have completed at least one line of therapy in the advanced/metastatic setting prior to enrollment
• Participants with advanced disease for which approved second-line options exist will be eligible when they have progressed beyond such approved second-line therapy
• Age ≥ 18 years. Because there is no data for evaluating these compounds in pediatric populations, the appropriate clinical trial can be conducted in the future in this specific population.
• ECOG performance status of 0-1 (Karnofsky ≥70%, see Appendix A)
• Life expectancy of greater than 12 weeks
• Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements:
• Hemoglobin ≥8.5 g/dL
• Absolute neutrophil count (ANC) ≥2 x 10/9/L
• Platelet count ≥100 x 10/9/L

You may not qualify if:

• Prior radiotherapy is permitted but must have occurred ≥2 weeks (palliative radiotherapy) or ≥ 4 weeks (curative radiotherapy) and subject must have no Grade 3 or 4 toxicities prior to first dose of study treatment
• Prior chemotherapy is allowed. Patients must not have received chemotherapy for 3 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of any prior chemotherapy. Patients must not have had nitrosoureas or mitomycin C for 6 weeks prior to the initiation of study treatment.
• Prior exposure to approved receptor tyrosine kinase inhibitors is permitted. At least 5 half-lives must have elapsed since the completion of the kinase inhibitor and the initiation of study treatment.
• Prior experimental (non-FDA approved) therapies and immunotherapies are allowed. Patients must not have received these therapies for 4 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies.
• Participants must not have received pan-cyclin-dependent kinase inhibitors as prior therapy.
• Current or ongoing administration of anticoagulation or antiplatelet therapy. However, use of low-dose aspirin (≤100 mg/day) and/or low-dose heparin is permitted unless it is being used for conditions other than cancer
• Known hypersensitivity to any of the study treatments or excipients of the preparations or any agent given in association with this study
• Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism
• History of cardiac disease: Congestive heart failure New York Heart Association (NYHA) Class III or IV angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
• Known human immunodeficiency virus infection, active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy
• Active clinically serious infections of NCI-CTCAE v4.0 \>Grade 2
• Seizure disorder requiring therapy (such as steroids or anti-epileptics)
• Concomitant use of other medications that are known to lower the seizure threshold
• Symptomatic metastatic brain or meningeal tumors, including those of the spinal cord, and including cases of neoplastic meningitis (also known as carcinomatous meningitis or leptomeningeal carcinomatosis).
• History of organ allograft

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Bayer: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

roniciclib

Study Officials

• Geoffrey Shapiro, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

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: January 11, 2016
• First Posted: January 15, 2016
• Study Start: February 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: May 1, 2023
• Last Updated: July 1, 2016

Record last verified: 2016-06

Locations

US (1)