Dose-escalation, Safety and Pharmacokinetic Study of Briciclib in Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Neoplasms, Advanced Solid Tumor

In brief

The main objectives of this study are to determine the safety profile of briciclib, an experimental anti-cancer drug, as it is administered intravenously once weekly as escalating doses in adult patients with advanced cancer and solid tumors, and to determine the highest dose of briciclib that can be safely given. Secondary objectives are to determine how the amount of briciclib in circulation changes over time and how much briciclib gets into the urine for excretion, and to document potential anti-tumor effects of briciclib.

Key facts

Study ID

NCT02168725

Run by

Traws Pharma, Inc.

People needed

26

Starts

2014-06-01

Expected to finish

2015-12-01

Last updated by the study team

2021-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed solid tumor (leukemia and lymphoma are excluded)
• Malignancy that is incurable and for which standard (FDA approved or established standard clinical practice) curative, or palliative measures do not exist or are no longer effective
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Minimum expected life expectancy > 6 months
• One or more measurable lesion(s) ("target lesion[s]") that can be accurately measured in at least 1 dimension
• Willing to adhere to the prohibitions and restrictions specified in the protocol
• The patient must sign an informed consent form (ICF)

You may not qualify if…

• Recent major surgery (within the past 14 days)
• Chemotherapy or dose of other potentially myelosuppressive treatment within 3 weeks prior to Screening (6 weeks for nitrosoureas or mitomycin C)
• No more than a total cumulative dose of 450 mg/m\^2 of prior doxorubicin chemotherapy
• Definitive radiotherapy (> 10 fractions and maximal area of hematopoietic active Bone Marrow treated greater than 25%) within 4 weeks prior to Screening
• Palliative radiotherapy (≤ 10 fractions) within 2 weeks prior to Screening
• Known brain metastases, except brain metastases that have been previously removed or irradiated and currently have no clinical impact
• Residual adverse events due to previously administered agents (except alopecia, stable residual neuropathy, and residual hand, foot syndrome) that have not recovered to Grade 1 or below in severity level (based on NCI CTCAE) before Screening
• Ascites requiring active medical management, including paracentesis
• Pleural effusion requiring active medical management
• Peripheral bilateral edema requiring active medical management
• Hyponatremia (serum sodium value less than 130 mEq/L)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to briciclib
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, bleeding, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• History of myocardial infarction
• Any other concurrent investigational agent or chemotherapy, radiotherapy, hormonotherapy, or immunotherapy. Exceptions are long-term hormonals for prostate (eg, goserelin) and octreotide for neuroendocrine malignancies
• Patients who are positive for human immunodeficiency virus type 1 (HIV-1) and are receiving combination anti-retroviral therapy
• Hemoglobin (Hgb) < 9 g/dL
• White Blood Cell count (WBC) < 4,000/µL
• Absolute Neutrophil Count (ANC) < 1,500/µL
• Platelet (PLT) count ≤ 100,000/µL
• Total bilirubin greater than 1.5 x the institutional upper limit of normal (ULN)
• Aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 2.5 x institutional ULN. If liver function abnormalities are due to metastatic disease, patients are eligible provided the ALT and AST are < 5 x ULN
• Serum creatinine > 2 x ULN

Where it is running

• University of Colorado Hospital Anschutz Medical Campus — Aurora, Colorado, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.