Phase 1 Ovarian Cancer Trial, Recruiting NCT04516447 Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Condition: Ovarian Cancer
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Phase 1 Ovarian Cancer Trial, Recruiting

NCT04516447
Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For Part 1:

  • People who have been diagnosed with a confirmed advanced-stage (Stage III or IV) high-grade cancer of the ovaries, fallopian tubes, or peritoneum of a specific type (serous or endometrioid).
  • People who have received 1 or 2 previous treatment courses for advanced or spread cancer, where at least one treatment included a platinum-based chemotherapy drug (cisplatin or carboplatin).
  • People whose cancer came back within 6 months of their last platinum-based treatment, or whose cancer did not respond to that treatment at all.

For Part 2 – Dose Escalation:

  • People who have completed 6 cycles of platinum-based combination chemotherapy as their most recent treatment (either first or second course of treatment).
  • People whose cancer showed a complete response, partial response, or stable disease during their first course of platinum-based chemotherapy.
  • People in their second course of treatment whose cancer progressed more than 183 days after their last platinum dose in the first course, and whose cancer then showed a complete response, partial response, or stable disease to the second course of platinum chemotherapy.
  • People with adequate blood counts and organ function.

For Part 2 – Dose Expansion:

  • People who have completed at least 4 cycles of platinum-based chemotherapy as a second course of treatment and whose cancer showed a complete response, partial response, or stable disease.
  • People whose cancer progressed while receiving a specific type of maintenance therapy drug called a PARP inhibitor after their first course of treatment.

Who may not be able to join:

  • People whose cancer has been diagnosed as an abdominal cancer of unknown origin, or as a borderline ovarian tumour.
  • People with a cancer type called carcinosarcoma, even if it contains a serous component.
  • People with a serious illness or significant medical condition (confirm with trial site for specifics).
  • People who have a second cancer that is active, uncontrolled, has spread, or currently requires treatment.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 8582634333

Australian sites

Site 2707, South Brisbane, Queensland
Site 2708, Sunshine Coast, Queensland
Site 2709, Adelaide, South Australia
Site 2716, Melbourne, Victoria
Site 2706, Melbourne, Victoria
Site 2705, Nedlands, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Registry
ClinicalTrials.gov
Start date
26 October 2020
Est. completion
30 June 2028

Where this trial is recruiting

🇦🇺 Australia Bosnia and Herzegovina 🇧🇬 Bulgaria 🇬🇪 Georgia 🇷🇸 Serbia 🇰🇷 South Korea 🇺🇸 United States

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine; Part 1: To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine; Part 2: To estimate the safety/tolerability of azenosertib in combination with bevacizumab; Part 2: To identify the recommended dose for Part 2 Dose Expansion

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov