Phase I Study in Advanced Solid Tumors

Solid Tumors Clinical Trial

Official title:

IBL1002:Phase I Study of Indibulin in Advanced Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00591292
• Other study ID #: IBL1002
• Status: Active, not recruiting
• Phase: Phase 1
• First received: December 26, 2007
• Last updated: July 18, 2012
• Start date: June 2007
• Est. completion date: June 2013

Study information

• Verified date: July 2012
• Source: Ziopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Dose escalating study of orally administered indibulin at twice daily schedule in subjects with solid tumors.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 entry

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.

Study Design

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• indibulin
Dose escalation of indibulin given twice daily for up to 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziopharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	toxicities		6 months	Yes
Secondary	pharmacokinetics		6 months	No