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An Open-Label Phase I/IIa Study of Intravenous BAL101553 in Adult Patients With Advanced Solid Tumors

Phase 1/Phase 2
18 Years
Open (Enrolling)
Solid Organ Tumors

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Trial Information

An Open-Label Phase I/IIa Study of Intravenous BAL101553 in Adult Patients With Advanced Solid Tumors

Inclusion Criteria:

1. Age ≥ 18 years

2. Patients with confirmed diagnosis of advanced or recurrent solid tumor, who failed
standard therapy or for whom no effective standard therapy is available

3. Measurable tumor disease (or non-measurable prostate or ovarian cancer that can be
followed by PSA or CA-125)

4. Life expectancy ≥ 12 weeks

5. Acceptable organ and marrow function at baseline (protocol defined laboratory

6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

7. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Patients who have received chemotherapy, radiotherapy, immunotherapy, or
investigational agents within 4 weeks prior to starting study drug or who have not
recovered from side effects of prior therapies

2. Symptomatic brain metastases (including leptomeningeal disease) indicative of active

3. Peripheral neuropathy ≥ CTCAE v4 grade 2

4. Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or
limit compliance with study requirements

5. Women who are pregnant or breast-feeding. Men or women of reproductive potential who
are not willing to apply effective birth control

6. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg observed
as part of the screening examination.

7. Other protocol-defined exclusion criteria may apply.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553

Outcome Description:

First-cycle dose limiting toxicities (DLT)

Outcome Time Frame:

28 day cycles

Safety Issue:



United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

June 2011

Completion Date:

Related Keywords:

  • Solid Organ Tumors