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An Open-label, Multiple-Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Chemotherapy-Induced Thrombocytopenia

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Trial Information

An Open-label, Multiple-Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia


Inclusion Criteria:



- Signed written informed consent

- Age ≥ 18 years

- Patients with confirmed solid tumor and scheduled to receive at least two cycles of
myelosuppressive chemotherapy on Day 1 every 21 days at the same dosage and schedule
in the study.

- Experienced thrombocytopenia as evidenced by a platelet count < 100 Gi/L in the
preceding cycle immediately before study enrollment.

- ECOG performance status ≤ 2

- For females, surgically sterilized, postmenopausal or agree to use an acceptable form
of birth control

- Patients treated with novel anticancer agents (e.g. bevacizumab, erlotinib,
trastuzumab, cetuximab) may be allowed if it is considered the standard treatment by
the investigator and after consultation and approval from the Sponsor

- PT/INR and aPTT are within 80% to 120% of the normal range

Exclusion Criteria:

- Experienced thrombocytopenia as evidenced by a platelet count < 25 Gi/L at any time
in the preceding cycle immediately before enrollment into the study

- History or presence of clinically significant disease

- Received any TRAs, or rHuIL-11 within the last 4 weeks prior to screening

- Had received a bone marrow or peripheral blood stem cell infusion (within 1 year of
screening).

- Pregnant, wanting to become pregnant or lactating

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of ONO-7746 across ascending multiple doses using vital signs, physical examinations, ECGs, ECOG performance status, CT/MRI, laboratory tests

Outcome Time Frame:

up to four 21-day cycles (up to 84 days)

Safety Issue:

Yes

Principal Investigator

Ono Pharma USA, Inc.

Investigator Role:

Study Director

Investigator Affiliation:

Ono Pharmaceutical Co. Ltd

Authority:

United States: Food and Drug Administration

Study ID:

ONO-7746POU003

NCT ID:

NCT01345214

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Chemotherapy-Induced Thrombocytopenia
  • ONO-7746
  • Chemotherapy Induced Thrombocytopenia
  • Thrombocytopenia
  • Thrombocytopenia

Name

Location

Fort Collins Clinical Site 13-01Fort Collins, Colorado  80528
Augusta Clinical Site 01-01Augusta, Georgia  30901
Ames Clinical Site 07-01Ames, Iowa  50010
Bronx Clinical Site 02-01Bronx, New York  10461