Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Browse trials for

• Fallopian Tube Neoplasms 715
• Ovarian Neoplasms 2,691

Keywords

• CYP3A inhibitor
• TOP1 inhibitor payload

Study arms

• Experimental
  AZD5335/AZD5335 + Itraconazole

  In Part A, participants will receive AZD5335 alone as an intravenous (IV) infusion, and in combination with oral itraconazole, every 3 weeks (Q3W) from cycle 1 to cycle 3. In Part B, participants will receive AZD5335 as an IV infusion Q3W, from Day 1 of Cycle 4 until progression, unacceptable toxicity or any other specified criteria for discontinuation occurs.

  Drug: AZD5335 · Drug: Itraconazole

Interventions

• DrugAZD5335

  AZD5335 will be administered as IV infusion.

  Also known as: AZ14170132

• DrugItraconazole

  Itraconazole capsule will be administered orally.

Primary outcomes

1. Area under curve from time 0 to time 17 days (AUC0-17days)

   The effect of itraconazole on the pharmacokinetics (PK) of AZ14170132 will be assessed.

   Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

2. Maximum plasma drug concentration (Cmax)

   The effect of itraconazole on the PK of AZ14170132 will be assessed.

   Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

Secondary outcomes

1. Maximum plasma drug concentration (Cmax)

   Cmax of AZ14170132 will be assessed.

   Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

2. Area under curve from time 0 to time 17 days (AUC0-17days)

   AUC0-17days of AZ14170132 will be assessed.

   Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

3. Minimum plasma drug concentration (Cmin)

   Cmin of AZ14170132 will be assessed.

   Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

4. Area under curve from time 0 to the time of last measurable concentration (AUC0-t)

   AUC0-t of AZ14170132 will be assessed.

   Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

5. Terminal elimination (lambda_z)

   lambda\_z of AZ14170132 will be assessed.

   Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

6. Half life (t1/2)

   t1/2 of AZ14170132 will be assessed.

   Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

7. Time to maximum observed concentration (tmax)

   tmax of AZ14170132 will be assessed.

   Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

8. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

   The safety and tolerability of AZD5335 alone and in combination with itraconazole will be assessed.

   Time frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose

9. Objective response rate (ORR)

   The ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR), with the denominator defined as the number of participants in the response evaluable set.

   Time frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose

10. Duration of response (DoR)

    The DoR is defined as the time from the date of first documented objective response (which is subsequently confirmed) until date of first documented disease progression or death (by any cause in the absence of disease progression).

    Time frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose

11. Progression-free Survival (PFS)

    The PFS is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.

    Time frame: From Day 1 until until disease progression or death (up to 2 years)

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.