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An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Docetaxel and Cisplatin Every 3 Weeks in Patients With Advanced Solid Tumors

Phase 1
20 Years
75 Years
Not Enrolling
Neoplasms, Malignant

Thank you

Trial Information

An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Docetaxel and Cisplatin Every 3 Weeks in Patients With Advanced Solid Tumors

The duration of the study for each patient will include an up to 4-week screening phase,
21-day study treatment cycles, an end of treatment visit and a follow-up period 30 days
after the last infusion of ombrabulin. The patient will continue treatment until disease
progression, unacceptable toxicity, patient's refusal of further treatment.

Inclusion Criteria

Inclusion criteria:

- Patients with advanced solid tumor for which docetaxel and cisplatin is approved such
as lung cancer, epithelial ovarian cancer.

Exclusion criteria:

- Eastern Cooperative Oncology Group performance status > or = 2.

- Concurrent treatment with any other anticancer therapy.

- Male or female patients who do not agree with contraception.

- Washout period of less than 28 days from prior anticancer therapies (chemotherapy,
targeted agents, immunotherapy and radiotherapy) or any investigational treatment,
except for nitrosoureas, mitomycin which may not be used up to 42 days prior to the
first cycle. No washout period is required for hormonal therapy that has to be
discontinued before the first cycle.

- Not recovered from all previous therapies (radiation, surgery, and medications).
Adverse events related to previous therapies must be National Cancer Institute Common
Terminology Criteria (NCI-CTCAE V3.0) grade < or = 1 (or alopecia < or = grade 2) at
screening or returned to the subject's baseline prior to their most recent previous

- Symptomatic brain metastases and carcinomatous leptomeningitis.

- Other serious illness or medical conditions not controlled by adequate treatment

- Patients with more than 1 line of previous chemotherapy for advanced or metastatic
disease (adjuvant/neoadjuvant and targeted agents [eg gefitinib] excluded).

- Current peripheral neuropathy > or = grade 2 and ototoxicity, of any origin including
significant residual symptoms due to the use of neurotoxic drugs (eg vincaalkaloids,
platinum and taxanes).

- Inadequate organ function

- Documented medical history of myocardial infarction, documented angina pectoris,
arrhythmia especially severe conduction disorder such as second or third degree
atrio-ventricular block, stroke, or history of arterial or venous thrombo-embolism
within the past 180 days requiring anticoagulants.

- Patient with a left ventricular ejection fraction <50% by echocardiography.

- Patients with a baseline QTc interval >0.45, or family history of Long QT Syndrome.

- Patient with uncontrolled hypertension and patient with organ damage related to
hypertension such as left ventricular hypertrophy or grade 2 ocular fundoscopic
changes or kidney impairment.

- Patients with growing vessel disease (eg age-related macular degeneration, diabetic
retinopathy, rheumatoid arthritis), or ongoing wound healing process. Patients should
be enrolled in the study at least 28 days after surgery.

- 12-lead Electrocardiogram: ST- and T-wave changes suggesting ischemia

- Hypertension defined as systolic blood pressure (BP)>140 mmHg or diastolic BP>90 mmHg
on two repeated measurements at 30 minutes intervals.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:


Study Design:

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

Outcome Measure:

Dose limiting toxicity

Outcome Time Frame:

3 weeks (cycle 1)

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

May 2010

Completion Date:

December 2011

Related Keywords:

  • Neoplasms, Malignant
  • Neoplasms