JPRN-jRCT2031180150
Active, not recruiting
Phase 2
A phase 2 basket trial of combination therapy with trastuzumab and pertuzumab in patients with solid cancers harboring HER2 amplification (JUPITER trial)
Ikeda Sadakatsu0 sites38 target enrollmentFebruary 25, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Solid tumors
- Sponsor
- Ikeda Sadakatsu
- Enrollment
- 38
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient with a histologically\-proven locally advanced or metastatic biliary tract cancer, urothelial cancer, uterine cancer, ovarian cancer and other solid tumors except breast cancer, gastric cancer and colorectal cancer who is no longer benefitting from standard anti\-cancer treatment or for whom, in the opinion of the investigator, no such treatment is available or indicated.
- •2\. HER2 gene amplified tumor identified using next genome sequencing in a CLIA or CAP accredited laboratory.
- •3\. Patient must have measurable or evaluable disease (per RECIST v1\.1\).
- •4\. Able to provide tumor samples for genome sequencing (not apply if HER2 amplification was detected by FoundationOne CDx) .
- •5\. 20 years of age or older
- •6\. ECOG PS 0\-1
- •7\. Normal organ function as below
- •a. Hb \>\= 9\.0g/dl
- •b. ANC \>\= 1,500/mm^3
- •c. PLT \>\= 75,000/mm^3
Exclusion Criteria
- •1\. Ongoing toxicity \> CTCAE grade 2, other than peripheral neuropathy, related to antitumor treatment that was completed within 4 weeks prior to registration. Patients with ongoing peripheral neuropathy of \>\= CTCAE grade 3 will be excluded.
- •2\. Previous treatment with trastuzumab or pertuzumab for the same malignancy
- •3\. If the patient's tumor has a genomic variant known to confer resistance to trasutuzumab or pertuzumab.
- •4\. Patients with breast cancer harboring HER2 amplification/overexpression.
- •5\. Patients with gastric cancer harboring HER2 amplification/overexpression.
- •6\. Patients with colorectal cancer harboring HER2 amplification/overexpression.
- •7\. Prior chemotherapy, immunotherapy or radiotherapy within 4 weeks of enrollment.
- •8\. Primary brain tumor.
- •9\. Patients with symptomatic uncontrolled brain metastases.
- •10\. History of clinically significant cardiovascular disease.
Outcomes
Primary Outcomes
Not specified
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