Phase IB Study of Indibulin Using Positron-Emission Tomography (PET) Scans

Advanced Cancer Clinical Trial

Official title:

Phase IB Study to Evaluate the Biological Activity of Indibulin Using Positron-Emission Tomography (PET) Scans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591890
• Other study ID #: IBL1003
• Status: Completed
• Phase: Phase 1
• First received: December 26, 2007
• Last updated: July 18, 2012
• Start date: October 2007
• Est. completion date: March 2009

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

Single arm, open label, Phase IB study of indibulin capsules in subjects with advanced solid tumors; eligible subjects will have a baseline PET scan showing a standardized uptake value (SUV) of ≥5.0 in ≥1 lesion on an 18F-FDG (fluorine-18-labeled deoxyglucose) scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histological or cytological confirmation of advanced cancer, refractory to standard therapies.

2. Received at least one prior therapy and requires additional treatment.

3. =18 years of age.

4. ECOG performance score = 2 (see Appendix 3).

5. At least one measurable lesion as defined by RECIST (Response evaluation criteria in solid tumors) 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.

6. PET scan showing a standardized uptake value (SUV) of =5.0 in at least 1 lesion on an 18F-FDG (fluorine-18-labeled deoxyglucose) scale.

7. Life expectancy =12 weeks.

8. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted <2 weeks prior to Day 1:

• Creatinine =1.5 × upper limit of normal (ULN) or calculated creatinine clearance =50 cc/minute

• Total bilirubin =1.5 × ULN

• Alanine transaminase (ALT) and aspartate transaminase (AST) =2.5 × ULN

• White blood cell count =3.0 × 109/L

• Absolute neutrophil count (ANC) =1.5 × 109/L

• Platelets =100 × 109/L

• Hemoglobin =10 g/dL

9. Ability to tolerate repeated blood sampling and adequate vascular access.

10. Serum glucose levels =200 mg/dL.

11. Provide written informed consent in compliance with ZIOPHARM policies and the Independent Ethics Committee with jurisdiction over the site.

12. Subjects of childbearing potential must agree to use a barrier method of contraception throughout the study and for 3 months after study drug administration.

Exclusion Criteria:

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

2. Uncontrolled diabetes mellitus

3. Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation.

4. Pregnancy and/or lactation.

5. Uncontrolled systemic infection (documented with microbiological studies)

6. Any other anti-cancer or immunological therapy during the study or within 4 weeks of study entry. Mitomycin C or nitrosureas should not be given within 6 weeks of study entry.

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

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

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

10. 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.

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

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

Study Design

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• indibulin
dose escalation of indibulin given twice daily for 21 days, to be repeated every 28 days.

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	anti-tumor effect on PET Scan		7 weeks	Yes
Secondary	toxicities		6 months	Yes