Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors

NCT00726687 | Unknown Phase 1

• 1 other identifier: IBL1005
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief Summary

This is a phase 1b study of Indibulin in combination with Capecitabine in advanced solid tumors.

Conditions

Advanced Solid Tumors

Keywords

Cancer; Indibulin; Capecitabine; Xeloda

Outcome Measures

Primary Outcomes (1)

• toxicities

  6 months

Secondary Outcomes (1)

• pharmacokinetics

  6 months

Study Arms (1)

single

EXPERIMENTAL

Single arm designed to elicit Maximum Tolerated Dose

Drug: indibulin; Drug: capecitabine

Interventions

indibulin DRUG

indibulin, dose escalation, 400-600 mg taken twice every day

single

capecitabine DRUG

capecitabine, dose escalation, 875 mg/m2- 1250 mg/m2, taken twice daily for 14 days per 21 day cycle

Also known as: Xeloda

single

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 whom treatment with capecitabine is considered medically acceptable
• ≥18 years of age
• ECOG performance score ≤2 (see Appendix 2)
• Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines (see Appendix 3). 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
• Subjects on prophylactic anticoagulation (i.e., low-dose warfarin) are eligible provided the coagulation parameter levels are as follows: prothrombin time (INR of prothrombin time) \<1.1× institutional ULN
• 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 ≥1.50 cc/min (See Appendix 6 for calculation method)
• Total bilirubin ≤1.5×ULN
• Alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5×ULN (\<5×ULN for patients presenting with liver involvement)
• White blood cell count ≥3.0×109/L
• Absolute neutrophil count (ANC) ≥1.5×109/L
• Platelets ≥100×109/L
• Hemoglobin ≥10 g/dL

You may not qualify if:

• New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within 6 months (see Appendix 4)
• Severe renal impairment (creatinine clearance below 30 mL/min)
• Known dihydropyrimidine dehydrogenase deficiency (DPD)
• Any evidence of bleeding diathesis or coagulopathy
• International normalized ration (INR) \>1.5, unless the subject is on full-dose warfarin
• Subjects on full-dose anticoagulants (e.g., warfarin) are eligible provided that both of the following criteria are met:
• The subject must have 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 must not have any active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
• Pregnancy and/or lactation. To be enrolled, each woman of childbearing potential must have a negative pregnancy test, which will be repeated at the end of the study.
• Uncontrolled systemic infection (documented with microbiological studies)
• Anticancer chemotherapy or immunotherapy within 4 weeks of study entry or at any time during the study or investigational drug therapy outside of this trial during or within 4 weeks of study entry
• Mitomycin C or nitrosureas should not be given within 6 weeks of study entry.
• Radiotherapy within 3 weeks of study entry or at any time during the study. For target lesions that have been radiated within 3 months of study entry, only those lesions with documented progression post radiation will be allowed.
• Surgery within 4 weeks of start of study drug dosing, excluding tumor biopsy for pharmacodynamic parameters
• 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

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (3)

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Vancouver, Washington, 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; Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jonathan Lewis, MD

  Alaunos Therapeutics

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: August 1, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 19, 2012

Record last verified: 2012-07

Locations

US (3)