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

NCT00591383 | Unknown Phase 1

• 1 other identifier: IBL1004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Keywords

Cancer; Indibulin; Erlotinib

Outcome Measures

Primary Outcomes (1)

• toxicities

  6 months

Secondary Outcomes (1)

• pharmacokinetics

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Once Maximum Tolerated Dose (MTD) is determined an expanded cohort will be enrolled to evaluate efficacy.

Drug: indibulin; Drug: erlotinib

Interventions

indibulin DRUG

indibulin, dose escalation, 200 mg - 600 mg. Taken twice every day.

Also known as: ZIO-301

Single Arm

erlotinib DRUG

erlotinib taken at 150 mg every morning with food.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with advanced, histologically confirmed solid tumors for which no standard therapy exists and for whom treatment with erlotinib is considered medically acceptable.
• ≥18 years of age
• ECOG performance score ≤2
• 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.
• Life-expectancy ≥12 weeks
• No more than 2 prior chemotherapy regimens for metastatic disease
• 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
• Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.

You may not qualify if:

• New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within 6 months (see Appendix 5)
• Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation
• Subjects cannot be receiving cytochrome P450-inducing anticonvulsants (EIAEDs: eg, phenytoin, carbamazepine, phenobarbital, primidone, oxcarbezine)
• Subjects may not be taking CYP3A4 inducers (rifampicin)
• Subjects must not have any evidence of bleeding diathesis or coagulopathy
• Subjects with international normalized ration (INR) \>1.5 are excluded, unless the subject is on full dose warfarin
• 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.
• 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
• Pregnancy and/or lactation
• Uncontrolled systemic infection (documented with microbiological studies)
• 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.
• Prior treatment with EGFR inhibitors
• Radiotherapy during the study or within 3 weeks of study entry

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (1)

Unknown Facility

Houston, Texas, United States

Location

Related Publications (1)

• Kapoor S, Srivastava S, Panda D. Indibulin dampens microtubule dynamics and produces synergistic antiproliferative effect with vinblastine in MCF-7 cells: Implications in cancer chemotherapy. Sci Rep. 2018 Aug 17;8(1):12363. doi: 10.1038/s41598-018-30376-y.

  PMID: 30120268 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

indibulin; Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jonathan Lewis, MD

  Alaunos Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 11, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 19, 2012

Record last verified: 2012-07

Locations

US (1)