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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors

In brief

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

Key facts

Study ID

NCT00726687

Run by

Alaunos Therapeutics

People needed

7

Starts

2008-06-01

Expected to finish

2013-06-01

Last updated by the study team

2012-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Written informed consent in compliance with ZIOPHARM policies and the Institutional Review Board (IRB) having jurisdiction over the site
• Ability and willingness to undergo multiple venous punctures for serum PK sampling
• For the second phase of the trial (expanded cohort of 10), only capecitabine-naïve subjects will be included; prior therapy with 5-FU will be allowed
• Each man and woman of childbearing potential must agree to use a reliable method of contraception during the study and for 3 months following his or her last dose of study drug

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
• Substance abuse or medical, psychological or social conditions that may interfere with the subject's participation in the study or the evaluation of study results
• Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance with study protocol

Where it is running

• Study site — Indianapolis, Indiana, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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