PAZIT Study for Children and Young Adults With Relapsed or Refractory Sarcoma
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03139331|
Recruitment Status : Active, not recruiting
First Posted : May 3, 2017
Last Update Posted : April 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: Pazopanib Drug: Irinotecan Drug: Temozolomide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Pazopanib in Combination With Irinotecan and Temozolomide (PAZIT) for Children and Young Adults With Relapsed or Refractory Sarcoma|
|Actual Study Start Date :||June 6, 2017|
|Actual Primary Completion Date :||October 15, 2019|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: Pazopanib, irinotecan, temozolomide (PAZIT)
Patients will receive daily oral pazopanib on days 1-21 in a 21-day cycle. This will be combined with intravenous or oral irinotecan and oral temozolomide on days 1-5. Dosing of irinotecan will be from 25 to 37.5 mg/m2/day for IV dosing or from 45 to 67.5 mg/m2/dose for oral dosing and oral temozolomide will be 100 mg/m2/day for dose levels at each assigned dose level. In the absence of disease progression or unacceptable toxicity, patients will receive cycles of therapy repeating every 21 days for a maximum of 12 months on study.
Pazopanib will be administered orally as a tablet according to an assigned dose level per protocol. A cycle will be defined as 21 days. Drug dosing for the tablet formulation will be determined using a study-specific nomogram.
Patients will be given irinotecan at a dose of 25 mg/m2/dose IV on days 1-5 of a 21-day cycle during Cycle 1. In subsequent cycles, irinotecan may be given intravenously at a dose of 25 to 37.5 mg/m2/dose or orally at a dose of 45 to 67.5 mg/m2/dose on days 1-5 of a 21-day cycle.
Note that some patients enrolled on an earlier protocol version received 50 mg/m2/dose IV on days 1-5 of the first 21-day cycle and then either 50 mg/m2/dose IV or 90 mg/m2/dose orally for subsequent 21-day cycles. This higher dose level is no longer being given to newly enrolled subjects.
Temozolomide will be given at a dose of 100 mg/m2/dose orally on days 1-5 of each 21-day cycle.
- Maximum Tolerated Dose [ Time Frame: 3 weeks ]Maximum tolerated dose or recommended phase 2 dose of pazopanib administered in combination with irinotecan and temozolomide
- Number of Patients with Dose-Limiting Toxicities (DLTs) Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: 3 weeks ]
Toxicity will be graded using the CTCAE criteria, version 4.0. DLT will be defined as any of the events as defined per the protocol that are at least possibly, probably, or definitely attributable to the combination of pazopanib, irinotecan, and temozolomide. DLTs are generally grade 3 or greater in severity.
Dose limiting hematological and non-hematological toxicities are defined differently, per the protocol.
- Describing toxicities of PAZIT drug combination using NCI CTCAE Version 4.0 [ Time Frame: 3 weeks ]To describe any toxicities associated with the combination of pazopanib, irinotecan and temozolomide (PAZIT).
- Objective Response Rate Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: From treatment initiation until disease progression, an average of about 6 months ]The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Tumor response will be assessed using RECIST version 1.1.
- Progression-Free Survival (PFS) Using RECIST Version 1.1 [ Time Frame: From treatment initiation until disease progression, an average of about 6 months ]PFS is defined as the duration of time from start of treatment to time of tumor progression. Tumor response will be assessed using RECIST version 1.1.
- Overall Survival (OS) [ Time Frame: From treatment initiation until death, an average of about 1 year ]OS is defined as the duration of time from start of treatment to time of death from any cause.
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): NCT03139331
|United States, California|
|UCSF Benioff Children's Hospital, Oakland|
|Oakland, California, United States, 94609|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94158|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Kieuhoa Vo, MD, MAS||University of California, San Francisco|