Clinical Trials Logo

Clinical Trial Summary

Hypoxic cells in tumors have less oxygen than normal cells do, which leads to several changes inside the cells that lead to genetic chages making these cells resistant to treatment. The end result of this is increased tumor growth, spread of the tumor and poor outcome. Early studies have shown that [131]I-IAZA scans can help detect if there are hypoxic cells in the tumor. A [131]I-IAZA scan is a nuclear medicine test used to create pictures of the whole body after [131]I-IAZA is injected into a vein. Further scientific research will help understand how [131]I-IAZA is distributed throughout the body and how it can be used to treat hypoxic tumor cells. The purpose of this study is to : 1. Demonstrate the safety of [131]I-IAZA 2. To Determine the biodistribution and tumor avidity of [131]I-IAZA in patients with locally advanced or metastatic solid tumors. 3. To determine the optimal imaging time of [131]I-IAZA SPECT. 4. To collect data from imaging and plasma sampling for radiopharmacokinetic analysis of [131]I-IAZA. 5. To determine whole body dosimetry of [131]I-IAZA in selected patients. 6. To evaluate tumor dosimetry of [131]I-IAZA in patients with positive uptake. 7. To determine the radiation dose accrued in hypoxic tumors.


Clinical Trial Description

The proposed clinical trial will be a Phase I/II open-label, single site, radiopharmacokinetic and radiodosimetric study in participants with locally advanced or metastatic solid tumors. All participants will be administered oral potassium iodide tablets to block radioactive iodine uptake in the thyroid. After administration of 185 MBq [131]I-IAZA (range: 150 - 220 MBq), all participants will undergo a series of up to six whole body planar scans on a dual headed gamma camera, and blood sampling for radiopharmacokinetic evaluation. A single fecal sample will be collected for up to 5 participants 24 - 72 hours post-injection, if possible, and assessed for total radioactivity. A safety evaluation will be conducted on the first 10 consecutively enrolled participants (safety sub-group), consisting of: Thyroid stimulating hormone (TSH) pre-injection and 6 weeks ±1 week post-injection; vital signs pre-injection and after scans 3 and 4; haematology, and SMA-12 serum biochemistry profile pre-injection and after scans 3 and 4; and an AE assessment at each imaging time point, up to 8 days post-injection. The safety evaluation for the remaining participants will consist of an AE assessment at each imaging time point, up to 8 days post-injection of [131]I-IAZA. The radiodosimetry of [131]I-IAZA in different tissues will be determined in the first 5 consecutively enrolled participants from the planar images and the measured radioactivity in the fecal samples, if available. SPECT/CT imaging of the tumor(s) will be acquired at 19-36 hours post-injection for all the participants and will be used along with the planar images to determine the radiodosimetry and pattern of dose distribution within the tumor(s). Dosimetry data will be potentially correlated with the participants' health status, or other relevant information, as applicable . ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03427320
Study type Interventional
Source University of Alberta
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date December 2018
Completion date April 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03993873 - Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET Phase 1/Phase 2
Recruiting NCT05494918 - First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors Phase 1
Completed NCT02281409 - Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT01928459 - Phase 1b Trial of BGJ398/BYL719 in Solid Tumors Phase 1
Completed NCT01449370 - Dose Escalation Study of MLN1117 in Subjects With Advanced Cancer Phase 1
Recruiting NCT06031441 - A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors Phase 1
Completed NCT03059823 - A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors Phase 1
Terminated NCT03573544 - This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors. Phase 1/Phase 2
Active, not recruiting NCT03893955 - A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors Phase 1
Completed NCT00878423 - Study to Assess the Safety of Escalating Doses of AT13387 in Patients With Metastatic Solid Tumors Phase 1
Withdrawn NCT00149019 - Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies. Phase 2
Recruiting NCT03093116 - A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements Phase 1/Phase 2
Terminated NCT03854227 - A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors Phase 1
Recruiting NCT04094610 - A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations Phase 1/Phase 2
Active, not recruiting NCT01543763 - Pazopanib in Combination With PCI-24781 in Patients With Metastatic Solid Tumors Phase 1
Terminated NCT02228811 - A Study of DCC-2701 in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT05853367 - Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001) Phase 1
Completed NCT02097810 - Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations. Phase 1
Recruiting NCT05836324 - A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors Phase 1
Completed NCT03910530 - A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid Tumors Phase 1