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. 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: NCT03139331|
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : November 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: Pazopanib Drug: Irinotecan Drug: Temozolomide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 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 :||April 25, 2017|
|Estimated Primary Completion Date :||November 30, 2018|
|Estimated Study Completion Date :||November 30, 2019|
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 fixed doses of intravenous or oral irinotecan and oral temozolomide on days 1-5. Dosing of irinotecan will be 50 mg/m2/day for IV dosing or 90 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.
All patients will be given irinotecan at a dose of 50 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 50 mg/m2/dose or orally at a dose of 90 mg/m2/dose on days 1-5 of a 21-day cycle.
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 fixed doses of irinotecan and temozolomide
- Describing toxicities of PAZIT drug combination using the NCI CTCAE Version 4.0 [ Time Frame: 3 weeks ]To describe any toxicities associated with the combination of pazopanib, irinotecan and temozolomide (PAZIT).
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
|Contact: Holly Chen||415-353-9387||Holly.Chen@ucsf.edu|
|Contact: Elizabeth Pon||415-476-0660||Elizabeth.Pon@ucsf.edu|
|United States, California|
|UCSF Benioff Children's Hospital, Oakland||Recruiting|
|Oakland, California, United States, 94609|
|Contact: Jennifer Michlitsch, MD 510-428-3372 firstname.lastname@example.org|
|Principal Investigator: Jennifer Michlitsch, MD|
|UCSF Helen Diller Family Comprehensive Cancer Center||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Kieuhoa Vo, MD, MAS 415-476-3831 email@example.com|
|Principal Investigator: Kieuhoa Vo, MD, MAS|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Steven DuBois, MD 617-632-5640 firstname.lastname@example.org|
|Principal Investigator: Steven DuBois, MD|
|Principal Investigator:||Kieuhoa Vo, MD, MAS||University of California, San Francisco|