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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Ziopharm.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Ziopharm
ClinicalTrials.gov Identifier:
NCT00591383
First received: December 26, 2007
Last updated: July 18, 2012
Last verified: July 2012
  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.


Condition Intervention Phase
Advanced Solid Tumors
Drug: indibulin
Drug: erlotinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591383

Locations
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Ziopharm
Investigators
Study Director: Jonathan Lewis, MD Ziopharm
  More Information

No publications provided

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT00591383     History of Changes
Other Study ID Numbers: IBL1004
Study First Received: December 26, 2007
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ziopharm:
Cancer
Indibulin
Erlotinib

Additional relevant MeSH terms:
Neoplasms
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014