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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00591383
Recruitment Status : Unknown
Verified July 2012 by Ziopharm.
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2008
Last Update Posted : July 19, 2012
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: indibulin Drug: erlotinib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid Tumors
Study Start Date : January 2008
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single Arm
Once Maximum Tolerated Dose (MTD) is determined an expanded cohort will be enrolled to evaluate efficacy.
Drug: indibulin
indibulin, dose escalation, 200 mg - 600 mg. Taken twice every day.
Other Name: ZIO-301

Drug: erlotinib
erlotinib taken at 150 mg every morning with food.

Primary Outcome Measures :
  1. toxicities [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. pharmacokinetics [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00591383

United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Study Director: Jonathan Lewis, MD Ziopharm

Responsible Party: Ziopharm Identifier: NCT00591383     History of Changes
Other Study ID Numbers: IBL1004
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: July 19, 2012
Last Verified: July 2012

Keywords provided by Ziopharm:

Additional relevant MeSH terms:
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action