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A Phase 1, Open-label, Dose Escalation Study of ONX 0912 Administered Orally in Patients With Advanced Refractory or Recurrent Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors

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Trial Information

A Phase 1, Open-label, Dose Escalation Study of ONX 0912 Administered Orally in Patients With Advanced Refractory or Recurrent Solid Tumors


This is a Phase 1, open label, dose-escalation study to determine the safety, MTD, and
PK/PDn of ONX 0912 when administered orally (PO) on Days 1, 2, 3, 4, and 5 of a 14 day cycle
in patients with advanced refractory or recurrent solid tumor malignancies for which
standard curative measures do not exist or are no longer effective.


Inclusion Criteria:



- Disease Related

- Histologically confirmed advanced solid tumor that is refractory or recurrent
after standard treatments.

- At least one site of radiographically measurable disease of ≥ 2 cm in the
largest dimension by traditional computed tomography (CT) scanning technique or
≥ 1 cm in the largest dimension by spiral CT scanning (per RECIST criteria); or
if, in the Principal Investigator's opinion, evaluable disease can be reliably
and consistently followed, the patient may be eligible upon approval by the Onyx
Therapeutics, Inc., Medical Monitor.

- Demographic

- Males and females ≥ 18 years of age

- Life expectancy of more than three months

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

- Laboratory

- Adequate hepatic function, with bilirubin ≤ 1.5 times the upper limit of normal
(ULN), and alanine aminotransferase (ALT) ≤ 3 times ULN or ≤ 5 times ULN in the
presence of hepatic tumor involvement

- Absolute neutrophil count (ANC) ≥ 1500/mm3, hemoglobin ≥ 8 g/dL, and platelet
count ≥ 100,000/ mm3

1. Screening platelet count must be independent of platelet transfusions for
at least one week

2. Screening ANC must be independent of granulocyte- and
granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support
for at least one week and of pegylated G-CSF for at least two weeks

3. Patients may receive red blood cell (RBC) transfusions or receive
supportive care with erythropoietin or darbepoetin in accordance with
institutional guidelines

- Calculated or measured creatinine clearance of ≥ 30 mL/min; calculation using a
generally accepted formula such as that of Cockcroft and Gault: CrCl = [(140 -
Age) × Mass (kg) / (72 × Creatinine mg/dL)], multiply by 0.85 if female

- Ethical / Other

- Written informed consent in accordance with federal, local, and institutional
guidelines

- Female patients of childbearing potential must have a negative serum or urine
pregnancy test within three days of the first dose and agree to use dual methods
of contraception during the study and for one month following the last dose of
study drug. Post-menopausal females (> 45 years old and without menses for > 1
year) and surgically sterilized females are exempt from these requirements.
Male patients must use an effective barrier method of contraception during the
study and for one month following the last dose if sexually active with a female
of childbearing potential.

Exclusion Criteria:

- Disease Related

- Chemotherapy with approved or investigational anticancer therapeutics, including
steroid therapy, within four weeks prior to first dose of ONX 0912 or six weeks
for antibody therapy

- Radiation therapy or immunotherapy within three weeks prior to first dose;
localized radiation therapy within one week prior to first dose Patients with
brain metastases (patients with prior brain metastases are permitted, but must
have completed treatment and have no evidence of active CNS disease for at least
three months prior to first dose)

- Prior treatment with a proteasome inhibitor

- Concurrent Conditions

- Major surgery within three weeks prior to first dose

- Congestive heart failure (New York Heart Association Class III to IV),
symptomatic ischemia, or conduction abnormalities. Conduction system
abnormalities not clinically warranting intervention are allowed.

- Myocardial infarction within three months prior to first dose

- Active infection requiring systemic antibiotics, antivirals, or antifungals
within two weeks prior to first dose

- HIV infection (HIV seropositive)

- Active hepatitis A, B, or C infection

- Peripheral neuropathy of Grade ≥ 3 or Grade 2 with pain at the time of the first
dose

- Patients with pleural effusions requiring repeat thoracentesis or ascites
requiring repeat paracentesis

- Prior ONX 0912 therapy

- Hypersensitivity to ONX 0912 or any of its components

- Ethical / Other

- Female patients who are pregnant or lactating

- Psychiatric or medical conditions that in the opinion of the Investigator could
interfere with treatment

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)

Outcome Description:

To evaluate the safety and tolerability of ONX 0912 in patients with advanced refractory or recurrent solid tumors including determination of its Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) To determine the pharmacokinetics (PK) of ONX 0912

Outcome Time Frame:

31 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

2009-003

NCT ID:

NCT01129349

Start Date:

April 2010

Completion Date:

December 2012

Related Keywords:

  • Advanced Solid Tumors
  • Solid Tumors
  • Neoplasms

Name

Location

Sarah Cannon Research InstituteNashville, Tennessee  37203
South Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229
Oncology Research AssociatesScottsdale, Arizona  85258