Status:
UNKNOWN
Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors
Lead Sponsor:
Alaunos Therapeutics
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase 1b study of Indibulin in combination with Capecitabine in advanced solid tumors.
Detailed Description
The primary objective of the trial is to determine the maximum tolerated dose (MTD) and optimal dosing schedule of indibulin in combination with capecitabine in subjects diagnosed as having advanced s...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00726687
Start Date
June 1 2008
End Date
June 1 2013
Last Update
July 19 2012
Active Locations (3)
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1
Indianapolis, Indiana, United States
2
Las Vegas, Nevada, United States
3
Vancouver, Washington, United States