Phase I Study in Advanced Malignancies With 5-ALA
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04381806|
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : August 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: 5-ALA||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||This is a phase 1, open label, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study to determine the maximum tolerated doses (MTD) or recommended phase 2 doses (RP2D) of both ALA and RT. Once the MTDs are identified, the cohort providing the highest dose intensity at or below the MTD (if supported by emerging PK and biomarker data) will be selected for an expansion phase for the purpose of refining the safety assessment and assessing preliminary efficacy. The initial dose escalation phase will enroll at least 20 patients across a variety of tumor types, after which concurrent disease site-specific expansion cohorts will accrue, each consisting of 20 patients. Anatomic site-specific cohorts will include patients with symptomatic metastatic disease to specific anatomic regions, where varying toxicity may be expected (Head and Neck, Thorax and Abdomen/Pelvis).|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose Finding Study Of Low-dose Radiation With Sensitization Using 5-aminolevulinic Acid In Advanced Malignancies|
|Actual Study Start Date :||July 30, 2020|
|Estimated Primary Completion Date :||February 1, 2026|
|Estimated Study Completion Date :||February 1, 2027|
orally-administered 5-aminolevulinic acid (ALA) given as a radiosensitizer prior to low-dose radiation therapy (RT)
Patients enrolled in this study will receive 3 doses of ALA and fractions of radiation therapy during the course of one 21day cycle. Only one cycle per patient is allowed. Patients are followed through day 56 for adverse event and efficacy measures.
- Maximum Tolerated Dose [ Time Frame: 45 Days ]Determine the Maximum Tolerated Dose (MTD) of ALA and radiotherapy (RT) when administered concurrently.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381806
|Contact: Anthony Olszanskifirstname.lastname@example.org|
|Contact: Alex Martinezemail@example.com|