Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or in Combination With Capecita… (NCT03775525) | Clinical Trial Compass
UnknownPhase 1
Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or in Combination With Capecitabine in Metastatic Hormone Receptor Positive Breast Cancer
United States127 participantsStarted 2019-03-01
Plain-language summary
This Phase I/Ib study is a Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Monotherapy and in Combination with Capecitabine, Given Orally on a Daily Schedule in Patients with Advanced Solid Tumors or Lymphoma
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
General Inclusion Criteria:
* Patients with a pathologically confirmed diagnosis of advanced solid tumors or lymphoma.
* Tumor progression after receiving standard/approved therapies which may include chemotherapy, targeted agents, radio-immuno conjugates, check point inhibitors, where there is no approved therapy; or the patient is intolerant of standard of care or the patient declines standard of care treatment
* One or more metastatic tumors measurable, or evaluable, per RECIST v1.1 Criteria for solid tumors and Lugano Criteria for lymphoma
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Life expectancy of at least 3 months
* Age 18 years
* Signed, written IRB-approved informed consent
* A negative pregnancy test (if female)
* Acceptable liver function:
* Bilirubin ≤ 1.5 times upper limit of normal
* AST (SGOT), ALT (SGPT) and Alkaline phosphatase ≤ 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed)
* Acceptable renal function:
o Serum creatinine ≤ 1.5 times institutional ULN, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
* Acceptable hematologic status:
* Granulocyte ≥ 1500 cells/mm3
* Platelet count ≥ 100,000 (plt/mm3)
* Hemoglobin ≥ 9 g/dL
* Urinalysis:
o No clinically significant abnormalities
* Acceptable coagulation status (for patients on warfarin or other anti-coagulants, a PT/PTT considered by the PI …
What they're measuring
1
maximum tolerated dose (MTD)
Timeframe: 18 months
2
Recommended dose of GZ17-6.02 for future phase II clinical studies