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

T

Traws Pharma, Inc.

Status and phase

Terminated
Phase 1

Conditions

Neoplasms
Advanced Solid Tumor

Treatments

Drug: briciclib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02168725
Onconova 08-02
COMIRB 14-0565 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This will be a Phase I, 2-stage, open-label, dose-escalating, multicenter study of the 2-hour, once-a-week intravenous (IV) administration of briciclib in 3-week cycles, in up to 54 adult patients with advanced cancer and solid tumors. The study will be conducted in 2 stages: a dose-escalation stage to determine the Maximum Tolerated Dose (MTD) and a Recommended Phase 2 Dose (RPTD) confirmation stage. Patients with stable disease (SD) or response may remain treated on study until progression.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 ULN

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

briciclib
Experimental group
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.
Treatment:
Drug: briciclib

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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