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IBL1002:Phase I Study of Indibulin in Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Solid Tumors

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Trial Information

IBL1002:Phase I Study of Indibulin in Advanced Solid Tumors

Inclusion Criteria

Inclusion Criteria

1. Subjects with histological or cytological confirmation of advanced cancer,
refractory to standard therapies for their condition

2. ≥ 18 years of age

3. ECOG performance score ≤ 2 (see Appendix 3)

4. Eligible subjects MUST have at least one measurable lesion as defined by RECIST
guidelines (See Appendix 4). If the measurable disease is restricted to a solitary
lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable
lesions MUST not have been in a previously irradiated field or injected with
biological agents.

5. Life-expectancy ≥ 12 weeks

6. Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements to be conducted < 2 weeks prior to Baseline:

- Creatinine ≤ 1.5 X upper limit of normal (ULN) OR a calculated creatinine
clearance ≥ 50 cc/min

- Total bilirubin ≤ 1.5 X ULN

- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 X ULN

- White blood cell count ≥3.0 x 109/L

- Absolute Neutrophil Count (ANC) ≥1.5 x 109/L

- Platelets ≥100 x 109/L

- Hemoglobin ≥ 10 g/dL

7. Written informed consent in compliance with ZIOPHARM policies and the Human
Investigation Review Committee with jurisdiction over the site.

Exclusion Criteria

1. New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within
6 months (see Appendix 5)

2. Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation

3. Pregnant and/or lactating female (a reliable method of contraception must be used in
all men and in women of childbearing potential during the study and for 3 months
after last study drug administration).

4. Uncontrolled systemic infection (documented with microbiological studies)

5. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study
entry. Mitomycin C or nitrosureas should not be given within 6 weeks of study entry.

6. Radiotherapy during the study or within 3 weeks of study entry

7. Surgery within 4 weeks of start of study drug excluding tumor biopsy for
pharmacodynamic parameters

8. Investigational drug therapy outside of this trial during or within 4 weeks of study

9. History of an invasive second primary malignancy diagnosed within the previous 3
years except for Stage I endometrial/cervical carcinoma or prostate carcinoma treated
surgically, and non-melanoma skin cancer

10. Substance abuse, medical, psychological or social conditions that may interfere with
the subject's participation in the study or evaluation of the study results

11. Any condition that is unstable or which could jeopardize the safety of the subject
and his/her compliance with the study protocol.

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Jonathan Lewis, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

June 2013

Related Keywords:

  • Solid Tumors
  • cancer
  • tumor
  • solid tumor
  • advanced tumor
  • Neoplasms



Fountain Valley, California  92708