AZD5153 in Patients With Relapsed or Refractory Solid Tumors, Including Lymphomas (NCT03205176) | Clinical Trial Compass
CompletedPhase 1
AZD5153 in Patients With Relapsed or Refractory Solid Tumors, Including Lymphomas
United States, Canada49 participantsStarted 2017-06-30
Plain-language summary
This is a first-time-in-man (FTIM) multicenter, dose escalation study designed to investigate the safety, pharmacokinetics, and pharmacodynamics of AZD5153 in patients with malignant solid tumors, including lymphomas.
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion criteria
✓. Patient must be able to understand the nature of the study and provide a signed and dated, written informed consent prior to any study specific procedures, sampling or analyses.
✓. Patients should have the ability and willingness to comply with the study and follow-up procedures.
✓. Patients must have a solid tumor that is refractory to or intolerant of existing therapies known to provide clinical benefit for their clinical condition.
✓. Age ≥ 18
✓. Adequate organ function, determined by:
✓. Normotensive or well controlled blood pressure (BP) (\<140/90), with or without current antihypertensive treatment. If there is a diagnosis or history of hypertension, patient must have adequately controlled BP on a maximum of 2 antihypertensive medications, as demonstrated by 2 BP measurements taken in the clinical setting by a medical professional within 1 week prior to enrollment. It is strongly recommended that patients who are on antihypertensive medications be followed by a cardiologist or a primary care physician for management of BP while on the study. Patients on a hypertensive medication must be willing and able to check and record twice daily BP readings for a minimum of 3 weeks.
✓. ECOG performance status of 0-1
✓. Life expectancy ≥ 3 months
Exclusion criteria
✕. Patients who have been treated with most recent chemotherapy, radiotherapy, hormonal therapy, immunotherapy or investigational drugs within 21 days or 5 half-lives (whichever is shorter) from enrollment.
What they're measuring
1
Incidence of dose-limiting toxicity (DLT).
Timeframe: From the first dose of study treatment up to last day of cycle 1 (21 days)
✕. Minimum wash-out period for previous PARPi therapy is at least 14 days or 5 half-lives whichever is shorter, or until toxicity from previous PARPi therapy has fully recovered.
✕. Patient received more than 5 prior lines of treatment for an advanced solid tumor (including HGSO cancer, TNBC, mCRPC, or PDAC). Patients with lymphoma will be able to enroll without a restriction in the number of previous therapies received, if they otherwise meet eligibility criteria.
✕. Major surgery (excluding placement of vascular access) ≤ 21 days from the beginning of enrollment or minor surgical procedures ≤ 7 days. No waiting is required following implantable port and catheter placement.
✕. Patient is unable to swallow oral medications or has a gastrointestinal disorder (e.g., malabsorption) that would jeopardize intestinal absorption of AZD5153 and olaparib.
✕. Treatment with any of the following:
✕. Refractory nausea and vomiting, previous significant bowel resection that would preclude adequate absorption of study drug and chronic gastrointestinal disease including active or prior documented inflammatory bowel disease.