Expired Study
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Houston, Texas


Purpose:

Single arm, open label, Phase I, dose-escalation study of indibulin in combination with erlotinib in subjects with advanced histologically confirmed, solid tumors for which no standard therapy exists and for whom treatment with erlotinib is considered medically acceptable.


Criteria:

Inclusion Criteria: 1. Subjects with advanced, histologically confirmed solid tumors for which no standard therapy exists and for whom treatment with erlotinib is considered medically acceptable. 2. ≥18 years of age 3. ECOG performance score ≤2 4. Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. Measurable lesions MUST NOT have been in a previously irradiated field or injected with biological agents. 5. Life-expectancy ≥12 weeks 6. No more than 2 prior chemotherapy regimens for metastatic disease 7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted <2 weeks prior to Study Day 1: - Creatinine ≤1.5×upper limit of normal (ULN) OR a calculated creatinine clearance ≥50 cc/min - 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 8. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site. 9. Each man and woman of childbearing potential must agree to use a reliable method of contraception during the study and for 3 months following the last dose of study drug. 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. Subjects cannot be receiving cytochrome P450-inducing anticonvulsants (EIAEDs: eg, phenytoin, carbamazepine, phenobarbital, primidone, oxcarbezine) 4. Subjects may not be taking CYP3A4 inducers (rifampicin) 5. Subjects must not have any evidence of bleeding diathesis or coagulopathy 6. Subjects with international normalized ration (INR) >1.5 are excluded, unless the subject is on full dose warfarin 7. Subjects on full-dose anticoagulants (eg, warfarin) are eligible provided that both of the following criteria are met: - The subject has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin - The subject has no active bleeding or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices. 8. Subjects on prophylactic anticoagulation (ie, low-dose warfarin) are eligible provided their coagulation parameter levels are as follows: prothrombin time (INR of prothrombin time) <1.1×institutional ULN 9. Pregnancy and/or lactation 10. Uncontrolled systemic infection (documented with microbiological studies) 11. 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. 12. Prior treatment with EGFR inhibitors 13. Radiotherapy during the study or within 3 weeks of study entry 14. Surgery within 4 weeks of start of study drug excluding tumor biopsy for pharmacodynamic parameters 15. Investigational drug therapy outside of this trial during or within 4 weeks of study entry 16. 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 17. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results 18. Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance with the study protocol


Study is Available At:


Original ID:

IBL1004


NCT ID:

NCT00591383


Secondary ID:


Study Acronym:


Brief Title:

Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid Tumors


Official Title:

Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid Tumors


Overall Status:

Active, not recruiting


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

ZIOPHARM


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jonathan Lewis, MD
Study Director
ZIOPHARM

Study Dates

Start Date:January 2008
Completion Date:June 2013
Completion Type:Anticipated
Primary Completion Date:June 2013
Primary Completion Type:Anticipated
Verification Date:July 2012
Last Changed Date:July 18, 2012
First Received Date:December 26, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:pharmacokinetics
Time Frame:6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:toxicities
Time Frame:6 months
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:indibulin
Description:indibulin, dose escalation, 200 mg - 600 mg. Taken twice every day.
Arm Name:Single Arm
Other Name:ZIO-301
Intervention Type:Drug
Name:erlotinib
Description:erlotinib taken at 150 mg every morning with food.
Arm Name:Single Arm

Study Arms

Study Arm Type:Experimental
Arm Name:Single Arm
Description:Once Maximum Tolerated Dose (MTD) is determined an expanded cohort will be enrolled to evaluate efficacy.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:ZIOPHARM

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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