Carcinoma
Conditions
Keywords
Refractory, Progressive
Brief summary
This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Once the MTD for SPI-1620 is identified, a second phase of the study will focus on dose escalation of docetaxel studied in groups of 3-6 patients. This part of the study will assess the safety and tolerability of increasing doses of docetaxel administered with the optimal dose of SPI 1620 defined in Part I.
Detailed description
This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Eligible patients will receive SPI-1620 delivered intravenously over one minute on Days 1, 8 and 15. On Day 8 patients will undergo a series of four H215O PET Blood Flow (BF) scans which will be used to assess alterations in BF induced by SPI-1620 in tumor and non-tumor ROIs (Region of Interest). Fifteen minutes after receiving SPI-1620 on Day 15, patients will receive docetaxel, 60 mg/m2, administered by infusion over 1 hour. Accelerated dose escalation of SPI-1620 will be employed: one patient will be treated at each dose level with 100% increases between dose levels. If any grade 2 or higher, related AE occurs, the trial will revert to 3-patient cohorts with 40% dose escalation between groups. There will be no intrapatient dose escalation. Dose escalation will continue until there is either no further increase in tumor blood flow as assessed by H215O PET scan, or until significant toxicity is observed. Once the MTD for SPI-1620 is identified, a second phase of the study will focus on dose escalation of docetaxel studied in groups of 3-6 patients. This part of the study will assess the safety and tolerability of increasing doses of docetaxel administered with the optimal dose of SPI 1620 defined in Part I. If 60 mg/m 2 was tolerated in Part I then up to six patients in Part II will receive docetaxel at a dose of 80 mg/m2 once every 3 weeks. If this is tolerated the next group of patients will receive docetaxel 100 mg/m2 once every 3 weeks.
Interventions
DRUGSPI-1620
SPI-1620 in escalating doses from 0.5 μg/m2 intravenous over sixty seconds
Sponsors
Spectrum Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All of the following inclusion criteria must be met prior to participation in this study 1. The patient must sign an informed consent. A signed consent form is required prior to the performance of any protocol-related procedures or assessments. 2. The patient must be \>= 18 years of age. 3. The patient must have progressive or recurrent carcinoma and has failed all standard therapies for his/her tumor. 4. The patient must have a negative CT scan with contrast of the brain or MRI of the brain within 45 days of enrollment. 5. The patient must be using an acceptable/effective method of contraception if she is a female patient of childbearing potential. 6. The patient must have a negative serum pregnancy test within 14 days of entering the protocol if she is a female of childbearing potential. 7. The patient must have an ECOG score \<= 2. 8. The patient must be willing and able to abide by the protocol.
Exclusion criteria
None of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy. | every three weeks |
Secondary
| Measure | Time frame |
|---|---|
| To assess the pharmacokinetic and pharmacodynamic profiles of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy. | one week |
| To identify the optimum dose of SPI-1620 to be used in future Phase II studies. | every three weeks |
| To assess the safety and tolerability of doses of docetaxel from 60 mg/m2 to 100 mg/m2 when given following infusion of SPI 1620. | every three weeks |
Countries
United States
Outcome results
None listed