A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
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|ClinicalTrials.gov Identifier: NCT03236857|
Recruitment Status : Active, not recruiting
First Posted : August 2, 2017
Last Update Posted : November 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Malignancies Acute Lymphoblastic Leukemia (ALL) Acute Myeloid Leukemia (AML) Non-Hodgkin's Lymphoma Neuroblastoma||Drug: chemotherapy Drug: venetoclax||Phase 1|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies|
|Actual Study Start Date :||November 8, 2017|
|Estimated Primary Completion Date :||June 2, 2023|
|Estimated Study Completion Date :||June 2, 2023|
Experimental: Venetoclax with or without chemotherapy
Venetoclax administered orally once daily (QD) with various doses and dosing regimens with or without chemotherapy at the discretion of the investigator. Allowed chemotherapy regimens as outlined in the study protocol.
Dexamethasone and/or vincristine and/or pegasparaginase OR cytarabine and/or etoposide and/or pegasparaginase; tyrosine kinase inhibitor; cytarabine OR azacitidine OR decitabine; rituximab and/or dexamethasone and/or vincristine; cyclophosphamide and/or topotecan
Oral tablet for participants; Tablet for oral suspension (participants who cannot swallow a tablet)
- Number of Participants Experiencing Adverse Events [ Time Frame: Up to 9 months ]An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
- Number of Participants With Dose Limiting Toxicities (DLT) of Venetoclax Monotherapy [ Time Frame: First 21 days venetoclax monotherapy ]A DLT is any Grade 3 or higher non-hematologic adverse event (AE) with exceptions outlined in the protocol.
- Recommended Phase 2 dose (RPTD) of Venetoclax [ Time Frame: First 21 days venetoclax monotherapy ]Venetoclax RPTD is the dose determined based on adverse event reporting and dose-limiting toxicity information from all participants.
- Cmax of Venetoclax [ Time Frame: Up to approximately 2 weeks ]Maximum plasma concentration (Cmax) of venetoclax.
- Tmax of venetoclax [ Time Frame: Up to approximately 2 weeks ]Time to maximum plasma concentration (Tmax) of venetoclax.
- AUC0-24 Post-Dose of Venetoclax [ Time Frame: Up to approximately 2 weeks ]Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.
- Objective Response Rate (ORR) [ Time Frame: Up to 9 months ]ORR is defined as the proportion of participants who achieved a response according to established criteria described in detail in the study protocol.
- Partial Response (PR) Rate [ Time Frame: Up to 9 months ]PR is defined according to established criteria for each tumor type and is described in detail within the study protocol.
- Complete Response (CR) Rate [ Time Frame: Up to 9 months ]CR is defined according to established criteria for each tumor type and is described in detail within the study protocol.
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): NCT03236857
|Study Director:||ABBVIE INC.||AbbVie|