AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer

Conditions

• Advanced Solid Tumours

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• AZD9150 — DRUG
  AZD9150 will be administered as a 1-hour intravenous infusion either weekly (QW) or every two weeks (Q2W), depending on which arm the patient is enrolled in. AZD9150 will be provided as a liquid drug product in clear glass vials. Each vial will be labelled in accordance with GMP Annex 13 and per country regulatory requirement.
• Durvalumab — DRUG
  Durvalumab will be administered as a 1-hour intravenous infusion either every three weeks (Q3W) or every four weeks (Q4W), depending on which arm the patient is enrolled in. Durvalumab will be provided as a solution in clear glass vials. Each vial will be labelled in accordance with GMP Annex 13 and per country regulatory requirement.
• Cisplatin — DRUG
  Cisplatin will be infused over 30-60 minutes on Day 1.
• 5-Flourouracil — DRUG
  5-flourouracil will be continuously infused over Days 1 to 4 every three weeks for up to 18 weeks.
• Carboplatin — DRUG
  Carboplatin will be infused over 30 to 60 minutes on Days 1, 8, and 15, depending on which arm the patient is enrolled in, for up to 18 weeks.
• Gemcitabine — DRUG
  Gemcitabine will be infused over 30 minutes on Days 1 and 8 for up to 18 weeks.
• Nab-paclitaxel — DRUG
  Nab-paclitaxel will be infused over 30 to 40 minutes on Days 1, 8, and 15 for up to 18 weeks.

Study Details

This is a phase Ib/II, open-label multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of AZD9150 plus durvalumab alone or in combination with chemotherapy in patients with advanced, solid tumours and subsequently in patients with non-small-cell lung cancer (NSCLC)

Key Dates

Start date

Feb 7, 2018

Status verified

Aug 2024

Primary completion

Jan 17, 2020

Completion

Mar 28, 2024

Study Design

Enrollment

76 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A1
  Patients will receive AZD9150 every two weeks (Q2W) + durvalumab every four weeks (Q4W). There will be a 1 week AZD9150 lead-in prior to durvalumab dosing.
• Experimental: Arm A2
  Patients will receive AZD9150 once weekly (QW) + durvalumab every three weeks (Q3W) + Cisplatin on Day 1 + 5-flourouracil (5-FU) on Days 1 to 4. This regimen will be repeated every 3 weeks for up to 18 weeks. There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing.
• Experimental: Arm A3
  Depending on the results of Arm A2, Arm A3 may not be conducted. If Arm A3 is conducted, patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + cisplatin on Day 1 + 5-flourouracil (5-FU) over Days 1 to 4. This regimen will be repeated every 3 weeks for up to 18 weeks. There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing.
• Experimental: Arm A4
  Patients will receive AZD9150 every two weeks (Q2W) + durvalumab every three weeks (Q3W) + gemcitabine on Days 1 and 8. This regimen will be repeated every 3 weeks. In addition, the following will be added to the regimen: * For cisplatin-eligible patients: cisplatin on Day 1 (every 3 weeks for up to 12-18 weeks); or * For cisplatin ineligible patients: carboplatin on Day 1 and Day 8 (every 3 weeks for up to 12-18 weeks) There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing.
• Experimental: Arm A5
  Patients will receive AZD9150 every two weeks (Q2W) plus durvalumab every three weeks (Q3W) plus carboplatin on Day 1 plus nab-paclitaxel on Days 1, 8, and 15 (every 3 weeks for up to 12-18 weeks). There will be a 1 week AZD9150 + chemotherapy lead-in prior to durvalumab dosing.
• Experimental: Arm D: AZD9150 SC
  Part D will compare the single and steady state pharmacokinetics of AZD9150 given subcutaneously (SC) QW to AZD9150 given by IV QW in combination with durvalumab 1500 mg Q4W. Patients will be randomly assigned to either SC or IV AZD9150.
• Experimental: Arm D: AZD9150 IV
  Part D will compare the single and steady state pharmacokinetics of AZD9150 given subcutaneously (SC) QW to AZD9150 given by IV QW in combination with durvalumab 1500 mg Q4W. Patients will be randomly assigned to either SC or IV AZD9150.

Primary Outcome Measure

Part A: Maximum Tolerated Dose (MTD) in subjects receiving AZD9150 plus durvalumab and AZD9150 plus durvalumab plus chemotherapy. [ Time Frame: Through study completion (an average of 6 months). Dose-limiting toxicities (DLTs) will be assessed through 5 weeks for patients who do not receive chemotherapy or 3 weeks for patients receiving chemotherapy. ]

Locations (6)

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