Clinical trial · Interventional
Dose-escalation, Safety and Pharmacokinetic Study of Briciclib in Advanced Solid Tumors
A Phase I, Dose-escalation Study of the Safety, Pharmacokinetics and Efficacy of Weekly Intravenous Briciclib in Patients With Advanced Solid Tumors
NCT02168725CI-TRIAL-00052374terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was placed on hold by the FDA due to manufacturing issues and was not restarted.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| briciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- briciclib
- description
- The starting dose of briciclib in the Escalation Stage will be 17 mg/week, with subsequent dose escalation levels of 35 mg, 70 mg, 140 mg, 280 mg, 560 mg, and 1120 mg. The dose of briciclib in the RPTD Confirmation Stage will be the dose as determined during the escalation stage. At each dose level, briciclib will be administered as a 2-hour intravenous infusion, once-a-week per 3-week cycles.
- interventionNames
- Drug: briciclib
Primary outcomes (3)
- measure
- Number of patients with adverse events
- timeFrame
- Up to 1 year
- description
- Adverse events will be grouped by system organ class (SOC) and preferred term (PT) using the most recent version of the Medical Dictionary for Regulatory Activities (MedDRA), and will be summarized by worst grade according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
- measure
- Number of patients with Dose Limiting Toxicity (DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Histologically confirmed solid tumor (leukemia and lymphoma are excluded)
2. 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
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
4. Minimum expected life expectancy \> 6 months
5. One or more measurable lesion(s) ("target lesion\[s\]") that can be accurately measured in at least 1 dimension
6. Willing to adhere to the prohibitions and restrictions specified in the protocol
7. The patient must sign an informed consent form (ICF)
Exclusion Criteria:
1. Recent major surgery (within the past 14 days)
2. Chemotherapy or dose of other potentially myelosuppressive treatment within 3 weeks prior to Screening (6 weeks for nitrosoureas or mitomycin C)
3. No more than a total cumulative dose of 450 mg/m\^2 of prior doxorubicin chemotherapy
4. Definitive radiotherapy (\> 10 fractions and maximal area of hematopoietic active Bone Marrow treated greater than 25%) within 4 weeks prior to Screening
5. Palliative radiotherapy (≤ 10 fractions) within 2 weeks prior to Screening
6. Known brain metastases, except brain metastases that have been previously removed or irradiated and currently have no clinical impact
7. 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
8. Ascites requiring active medical management, including paracentesis
9. Pleural effusion requiring active medical management
10. Peripheral bilateral edema requiring active medical management
11. Hyponatremia (serum sodium value less than 130 mEq/L)
12. History of allergic reactions attributed to compounds of similar chemical or biologic composition to briciclib
13. 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
14. History of myocardial infarction
15. 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
16. Patients who are positive for human immunodeficiency virus type 1 (HIV-1) and are receiving combination anti-retroviral therapy
17. Hemoglobin (Hgb) \< 9 g/dL
18. White Blood Cell count (WBC) \< 4,000/µL
19. Absolute Neutrophil Count (ANC) \< 1,500/µL
20. Platelet (PLT) count ≤ 100,000/µL
21. Total bilirubin greater than 1.5 x the institutional upper limit of normal (ULN)
22. 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
23. Serum creatinine \> 2 x ULNReferences
Publications (0)
Data not yet available
No reference posted for this study.