Drug Class: Cell Cycle Inhibitors

Cell Cycle Inhibitors: Wee1 Inhibitors

Platinum-Resistant/Refractory (Pt-R/Rf): Treatment given for recurrence occurring less than 6 months after last platinum-based treatment or for progression during last platinum-based treatment

Objective Response Rate (%)

Percentage of patients whose tumors shrink or go away after treatment

Progression Free Survival (months)

Median length of time before the cancer comes back or gets worse

1 Prior Therapy 2 Prior Therapies 3 Prior Therapies

Treatment given for recurrence occurring at any time after last platinum-based treatment

Objective Response Rate (%)

Percentage of patients whose tumors shrink or go away after treatment

Progression Free Survival (months)

Median length of time before the cancer comes back or gets worse

4 Prior Therapies 5 Prior Therapies 6 Prior Therapies 7 Prior Therapies Prior Therapies Not Reported

Cell Cycle Inhibitors: Wee1 Inhibitors

Platinum-Sensitive (Pt-S): Treatment given for recurrence occurring 6 months or more after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT01357161 II Adavosertib, Carboplatin, Paclitaxel A Randomized, Phase II Study Evaluating MK-1775 in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Adult Patients With Platinum Sensitive p53 Mutant Ovarian Cancer

Improved PFS with addition of AZD1775

Ada+CarboPt+Pac vs CarboPt+Pac:

ORR: 81.4 vs 75.8%
PFS: 7.9 vs 7.3 months

pub 2020

Platinum-Resistant/Refractory (Pt-R/Rf): Treatment given for recurrence occurring less than 6 months after last platinum-based treatment or for progression during last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT01164995 II Adavosertib, Carboplatin Phase II Pharmacological Study With Wee-1 Inhibitor MK-1775 Combined With Carboplatin in Patients With p53 Mutated Epithelial Ovarian Cancer and Early Relapse (< 3 Months) or Progression During Standard First Line Treatment

Promising activity of adavosertib+carboplatin combination in TP53-mutated primary platinum resistant and platinum refractory ovarian cancer; a large proportion of responding patient had CCNE1 AMP

ORR: 41%
PFS: 5.6 months

pub 2016, pub 2023
NCT02101775 II Adavosertib, Gemcitabine A Randomized Placebo-Controlled Phase II Trial Comparing Gemcitabine Monotherapy to Gemcitabine in Combination With AZD 1775 (MK 1775) in Women With Recurrent, Platinum Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers

Addition of adavosertib to gemzar improves ORR, PFS and OS

Gem+Ada vs Gem:

ORR: 25 vs 7%
PFS: 4.6 vs 3.0 months*
OS: 11.4 vs 7.2 months*

pub 2021
NCT02272790 II Adavosertib, Carboplatin A Multicentre Phase II Study of Adavosertib Plus Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Adavosertib+carboplatin shows efficacy in primary platinum resistant ovarian cancer with greatest benefit in patients receiving adavosertib weeks 1–3+carboplatin, but with increased hematologic toxicity

Ada week 1+CarboPt:
ORR: 30.4%
PFS: 4.2 months

Ada week 1-3+CarboPt
ORR: 66.7% (n=12)
PFS: 12.0 months (n=12)

pub 2022
NCT04516447 I Azenosertib, Carboplatin, Liposomal doxorubicin, Paclitaxel, Gemcitabine A Phase 1b Study of ZN-c3 in Combination With Chemotherapy in Patients With Platinum-Resistant Ovarian, Peritoneal or Fallopian Tube Cancer

Azenosertib (ZN-c3), combined with chemotherapy, is well-tolerated and demonstrates clinical activity in patients with Pt-R or Pt-Rf OC

Aze+CarboPt:
ORR: 35.7%; DoR: 11.4 months; PFS: 10.4 months

Aze+Pac:
ORR: 50%; DoR: 5.6 months; PFS: 7.4 months

Aze+Gem: (n=13)
ORR: 38.5%; DoR: 6.2 months; PFS: 8.3 months

Aze+PLD:
ORR: 19.4%; DoR: 7.3 months; PFS: 6.3 months

abs Jun 2023 and poster
*Statistically significant result

Treatment given for recurrence occurring at any time after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT03579316 II Adavosertib, Olaparib EFFORT: Efficacy of AZD1775 in Parp Resistance; A Randomized 2-Arm, Non-Comparative Phase 2 Study of AZD1775 Alone or AZD1775 and Olaparib in Women With Ovarian Cancer Who Have Progressed During PARP Inhibition

Adavosertib alone and in combination with olaparib demonstrates efficacy in patients with PARPi-resistant OC irrespective of BRCA status

Ada+Ola vs Ada: ORR: 29 vs 23%; DoR: 6.4 vs 5.5 months: DCR (4 months): 89 vs 63%; PFS: 6.8 vs 5.5 months

BRCA MUT:
Ada+Ola vs Ada (n=15): ORR: 19 vs 20%; DoR: 6.4 vs 5.6 months; DCR (4 months): 81 vs 67%; PFS: 5.6 vs 5.6 months

BRCA WT:
Ada+Ola vs Ada: ORR: 39 vs 31%; DoR: 8.7 vs 4.1 months; DCR (4 months): 94 vs 69%; PFS: 8.4 vs 4.1 months

abs Jun 2021 and presentation
NCT02482311 Ib Adavosertib A Phase Ib, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumour Activity of AZD1775 Monotherapy in Patients With Advanced Solid Tumours

Adavosertib is well tolerated and shows preliminary antitumor activity. No clear correlation between genomic profile and clinical response

30 OC BRCA MUT after PARPi failure:
ORR: 3.3%
DCR: 77%
PFS: 3.9 month

16 OC BRCA WT:
ORR: 6.3%
DCR: 69%
PFS: 4.5 months

pub 2023
NCT02511795 Ib Adavosertib, Olaparib A Phase Ib Study of AZD1775 and Olaparib in Patients With Refractory Solid Tumours

Adavosertib+olaparib shows anti-tumor activity in ovarian cancer, particularly at the twice daily (BID) schedule

ORR: 15%
DCR: 85%
SD responses seen in 2 patients with CCNE1 AMP

abs Apr 2019 and poster

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