Advanced Cancers Clinical Trial
Official title:
A Pilot, Exploratory, Non-Randomized Study of PET/CT With the Investigational Agent [18F] Fluciclatide to Correlate With Response to Anti-Cancer Therapy
NCT number | NCT02193672 |
Other study ID # | 2013-0591 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 1 |
First received | July 11, 2014 |
Last updated | July 14, 2014 |
Start date | August 2014 |
Verified date | July 2014 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The goal of this clinical research study is to find out if using the tracer (liquid used in imaging scans) [18F]fluciclatide in positron emission tomography / computed tomography (PET/CT) scans will help researchers learn more quickly if the disease is responding to treatment.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patient is >/= 18 years and male or female of any race/ethnicity. 2. Patient or patient's legally authorized representative provides written informed consent and is willing to comply with protocol requirements. 3. Patient must be scheduled to receive an anti-VEGF inhibitor (bevacizumab, sorafenib, sunitinib, other), mTOR inhibitor (temsirolimus, everolimus, other), or other molecules with antiangiogenic properties including taxol as anti-cancer therapy. 4. Patient must have normal hepatic and renal function defined as: 1) AST (SGOT)/ALT (SGPT) </=3 x institutional upper limit of normal and 2) serum creatinine </= 2x institutional upper limit of normal. 5. Platelet count of > 75 x 10^3/µL 6. Patients may participate in clinical trials in the Phase I program. 7. Patients with any solid tumor type. Exclusion Criteria: 1. Patient is not capable of complying with study procedures. 2. Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of the following: 1) Confirming in medical history that the patient is postmenopausal defined as 12 consecutive months of amenorrhea, or surgically sterile, 2) Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: Intrauterine device (IUD), oral contraceptives, Depo-Provera, or Norplant, 3) Confirming a negative urine dipstick test taken the morning of receiving the investigational agent [18F]fluciclatide. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | GE Healthcare |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Tumor Uptake | Primary efficacy endpoint is change in tumor uptake of investigational agent [18F]Fluciclatide, as measured by standardized uptake value (SUVFluciclatide) from before treatment to after one cycle of treatment but before the second cycle starts. This determined from investigational agent [18F]Fluciclatide PET scans. Changes in SUVFluciclatide compared to standard tumor's response measured after completion of 2 cycles of treatment as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) as well as tumor size change as a continuous variable measured by the standard CT or PET/CT scans. Tumor size can also be measured by the WHO two-dimensional measurement in addition to the Response Evaluation Criteria in Solid Tumors (RECIST), one-dimensional measurement. Changes in SUVFluciclatide after one cycle also compared to tumor volume and tumor size as continuous variables after two cycles. | After 2, four week chemotherapy cycles | No |
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