A Phase 2 interventional study of adavosertib and Placebo in Ovarian Cancer, sponsored by Merck Sharp & Dohme LLC. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
This is a study of the safety and efficacy of adavosertib in combination with paclitaxel plus carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with the P53 mutation. In Part 1, a small group of participants will receive adavosertib along with paclitaxel plus carboplatin to establish the tolerability of adavosertib with this combination. In Part 2, participants will be randomly assigned to receive either adavosertib plus paclitaxel and carboplatin OR placebo plus paclitaxel and carboplatin to assess efficacy of adavosertib compared to placebo. The primary hypothesis of the study (Part 2) is that administration of adavosertib in combination with paclitaxel plus carboplatin in participants with platinum sensitive p53 mutant ovarian cancer will result in improvement in progression free survival (PFS) per enhanced Response Evaluation Criteria In Solid Tumors version 1.1 (enhanced RECIST 1.1) compared to participants treated with paclitaxel plus carboplatin alone.
2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.
This study's enrollment of 136 is above the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
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During the open-label run-in, participants receive 225 mg adavosertib twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants receive adavosertib in combination with paclitaxel (175 mg/m2) and carboplatin (area under the curve \[AUC\] 5).
Drug: adavosertib · Drug: paclitaxel · Drug: carboplatin
During Part 2, participants receive 225 mg adavosertib BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants receive adavosertib in combination with paclitaxel (175 mg/m2) and carboplatin (AUC 5).
Drug: adavosertib · Drug: paclitaxel · Drug: carboplatin
During Part 2, participants receive matched placebo to adavosertib BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants receive placebo in combination with paclitaxel (175 mg/m2) and carboplatin (AUC 5).
Drug: Placebo · Drug: paclitaxel · Drug: carboplatin
Adavosertib capsules, orally, twice a day (BID) for a total of 5 doses starting on Day 1 of each 3-week cycle
Also known as: MK-1775
placebo to adavosertib, capsule, orally, BID for a total of 5 doses, starting on Day 1 of each 3-week cycle
paclitaxel, intravenous (IV) infusion on Day 1 of each 3-week cycle
Also known as: Taxol
carboplatin, IV infusion on Day 1 of each 3-week cycle
Also known as: paraplatin
Part 2: Median Progression-free Survival (PFS) in Weeks Based on Enhanced Response Evaluation Criteria In Solid Tumors Version 1.1 (Enhanced RECIST 1.1) by Independent Radiology Review
PFS was defined as the time from randomization to progressive disease (based on blinded independent central radiologic review) or death, whichever occurred earlier. Tumor response was evaluated every 6 weeks during treatment by diagnostic anatomic imaging and objective response assessments were performed based on enhanced RECIST 1.1 criteria. According to enhanced RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR an unambiguous increase in the sum of target lesion volumes with both 1) \>20% increase in the sum of volumes (SOV) of all target lesions (taking as reference the nadir) and 2) greater than two times the variability of the measurements estimated by the sponsor and/or its designees. PFS was analyzed for Part 2 participants only using the Kaplan-Meier method and median PFS was reported in weeks. Per protocol, Part 1 participants were not included in this analysis.
Time frame: Up to 57 months
Part 1: Number of Participants With a Dose Limiting Toxicity (DLT)
DLTs assessed during first 21-day cycle of Part 1 and defined as toxicities that met pre-defined severity criteria, were possibly, probably, or definitely related to triplet therapy, and could possibly result in a change in the given dose. Hematologic DLTs included Grade (Gr) 3 or Gr 4 neutropenia with fever \>38.5°C and/or infection requiring antibiotic or anti-fungal treatment, and any Gr 4-5 hematological toxicity EXCEPT Gr 4 anemia, leukopenia, lymphopenia, neutropenia lasting \<7 days, and thrombocytopenia lasting \<4 days, except if a platelet transfusion was required. Non-hematologic DLT defined as any Gr 3, 4, or 5 nonhematologic toxicity EXCEPT: Gr 3 nausea, vomiting, diarrhea, or dehydration judged by Investigator and SPONSOR to occur in setting of inadequate compliance with supportive care measures and last for less than 48 hours, alopecia of any grade, inadequately treated hypersensitivity reactions, or clinically non-significant, treatable or reversible lab abnormalities.
Time frame: During Cycle 1 of Part 1 (first 21 days)
Parts 1 and 2: Percentage of Participants That Experienced an Adverse Event (AE)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm.
Time frame: Part 1: Day 1 through Post Study (286 days total). Part 2: Day 1 through Post Study (479 days total)
Parts 1 and 2: Percentage of Participants That Discontinued Study Treatment Due to an AE
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that discontinued study treatment (paclitaxel, carboplatin, or MK-1775) due to an AE was reported for each treatment arm.
Time frame: Part 1: Day 1 through Post Study (286 days total). Part 2: Day 1 through Post Study (479 days total)
Part 1: Objective Response Rate (ORR) Per Gynecological Cancer Intergroup (GCIG) Criteria Based on Both RECIST 1.1 and Cancer Antigen 125 (CA-125) Level by Independent Radiology Review
ORR was defined as the percentage of participants whose best response was confirmed partial response (PR) or complete response (CR) based both on imaging per RECIST 1.1 and on serum marker CA-125 level according to GCIC criteria. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. A response according to CA-125 had occurred if there was ≥50% reduction in CA-125 levels from a pretreatment sample. The response must have been confirmed and maintained for at least 28 days. Participants could be evaluated according to CA-125 only if they had a pretreatment sample that was ≥2 times the upper limit of normal and within 2 weeks prior to starting treatment. Only evaluable Part 1 participants were included in this analysis.
Time frame: Up to 57 months
Part 2: Median PFS in Weeks Based on RECIST 1.1 by Independent Radiology Review
PFS was defined as the time from randomization to progressive disease (based on blinded independent central radiologic review) or death, whichever occurred earlier. Tumor response was evaluated every 6 weeks during treatment by diagnostic anatomic imaging and objective response assessments were performed based on RECIST 1.1 criteria. According to RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR a ≥20% increase in the sum of target lesion diameters (SOD) taking as reference the nadir (smallest SOD recorded since treatment started). PFS was analyzed for all randomized participants in Part 2 using the Kaplan-Meier method and median PFS was reported in weeks. Per protocol, Part 1 participants were not included in this analysis.
Time frame: Up to 57 months
Part 2: ORR Per GCIG Criteria Based on Both Enhanced RECIST 1.1 and CA125 Level by Independent Radiology Review
ORR defined as the percentage of participants with best response of confirmed PR or CR based both on imaging per enhanced RECIST 1.1 and on serum marker CA-125 level according to GCIC criteria. CR defined by enhanced RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have had reduction in short axis to \<10 mm. PR was defined by enhanced RECIST 1.1 as ≥30% decrease in SOV of target lesions, taking as reference baseline SOV. Response according to CA-125 had occurred if there was ≥50% reduction in CA-125 levels from pretreatment sample. Response must have been confirmed and maintained for ≥28 days. Participants could be evaluated according to CA-125 only if they had a pretreatment sample that was ≥2 times the upper limit of normal and within 2 weeks prior to starting treatment. All randomized participants in Part 2 were analyzed. Per protocol, Part 1 participants were not included in this analysis.
Time frame: Up to 57 months
Part 2: Median Overall Survival (OS) in Months
OS was defined as the time from randomization to death due to any cause, reported in months. Participants without documented death at the time of analysis were censored at the date last known to be alive. For this endpoint, all randomized participants in Part 2 were analyzed. Per protocol, Part 1 participants were not evaluated for OS.
Time frame: Up to 57 months
| Milestone | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin |
|---|---|---|---|
| Started | 15 | 0 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 15 | 0 | 0 |
| Withdrew: Death | 5 | 0 | 0 |
| Withdrew: Lost to follow-up | 3 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 5 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Milestone | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin |
|---|---|---|---|
| Started | 0 | 59 | 62 |
| Treated | 0 | 59 | 60 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 59 | 62 |
| Withdrew: Death | 0 | 22 | 19 |
| Withdrew: Lost to follow-up | 0 | 1 | 6 |
| Withdrew: Physician decision | 0 | 1 | 4 |
| Withdrew: Progressive disease | 0 | 1 | 3 |
| Withdrew: Study terminated by sponsor | 0 | 29 | 26 |
| Withdrew: Withdrawal by subject | 0 | 5 | 4 |
PFS was defined as the time from randomization to progressive disease (based on blinded independent central radiologic review) or death, whichever occurred earlier. Tumor response was evaluated every 6 weeks during treatment by diagnostic anatomic imaging and objective response assessments were performed based on enhanced RECIST 1.1 criteria. According to enhanced RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR an unambiguous increase in the sum of target lesion volumes with both 1) \>20% increase in the sum of volumes (SOV) of all target lesions (taking as reference the nadir) and 2) greater than two times the variability of the measurements estimated by the sponsor and/or its designees. PFS was analyzed for Part 2 participants only using the Kaplan-Meier method and median PFS was reported in weeks. Per protocol, Part 1 participants were not included in this analysis.
| weeks | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin |
|---|---|---|---|
| Part 2: Median Progression-free Survival (PFS) in Weeks Based on Enhanced Response Evaluation Criteria In Solid Tumors Version 1.1 (Enhanced RECIST 1.1) by Independent Radiology Review | — | 34.14 (29.86 to 43.14) | 31.86 (24.43 to 35.57) |
ORR was defined as the percentage of participants whose best response was confirmed partial response (PR) or complete response (CR) based both on imaging per RECIST 1.1 and on serum marker CA-125 level according to GCIC criteria. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. A response according to CA-125 had occurred if there was ≥50% reduction in CA-125 levels from a pretreatment sample. The response must have been confirmed and maintained for at least 28 days. Participants could be evaluated according to CA-125 only if they had a pretreatment sample that was ≥2 times the upper limit of normal and within 2 weeks prior to starting treatment. Only evaluable Part 1 participants were included in this analysis.
| percentage of participants | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin |
|---|---|---|---|
| Part 1: Objective Response Rate (ORR) Per Gynecological Cancer Intergroup (GCIG) Criteria Based on Both RECIST 1.1 and Cancer Antigen 125 (CA-125) Level by Independent Radiology Review | 75.00 (42.814 to 94.514) | — | — |
PFS was defined as the time from randomization to progressive disease (based on blinded independent central radiologic review) or death, whichever occurred earlier. Tumor response was evaluated every 6 weeks during treatment by diagnostic anatomic imaging and objective response assessments were performed based on RECIST 1.1 criteria. According to RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR a ≥20% increase in the sum of target lesion diameters (SOD) taking as reference the nadir (smallest SOD recorded since treatment started). PFS was analyzed for all randomized participants in Part 2 using the Kaplan-Meier method and median PFS was reported in weeks. Per protocol, Part 1 participants were not included in this analysis.
| weeks | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin |
|---|---|---|---|
| Part 2: Median PFS in Weeks Based on RECIST 1.1 by Independent Radiology Review | — | 42.86 (35.00 to 48.86) | 34.86 (30.43 to 36.86) |
DLTs assessed during first 21-day cycle of Part 1 and defined as toxicities that met pre-defined severity criteria, were possibly, probably, or definitely related to triplet therapy, and could possibly result in a change in the given dose. Hematologic DLTs included Grade (Gr) 3 or Gr 4 neutropenia with fever \>38.5°C and/or infection requiring antibiotic or anti-fungal treatment, and any Gr 4-5 hematological toxicity EXCEPT Gr 4 anemia, leukopenia, lymphopenia, neutropenia lasting \<7 days, and thrombocytopenia lasting \<4 days, except if a platelet transfusion was required. Non-hematologic DLT defined as any Gr 3, 4, or 5 nonhematologic toxicity EXCEPT: Gr 3 nausea, vomiting, diarrhea, or dehydration judged by Investigator and SPONSOR to occur in setting of inadequate compliance with supportive care measures and last for less than 48 hours, alopecia of any grade, inadequately treated hypersensitivity reactions, or clinically non-significant, treatable or reversible lab abnormalities.
| participants | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin |
|---|---|---|---|
| Total | 3 | — | — |
| Febrile neutropenia | 1 | — | — |
| Neutropenia | 1 | — | — |
| Thrombocytopenia | 1 | — | — |
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm.
| percentage of participants | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin |
|---|---|---|---|
| Parts 1 and 2: Percentage of Participants That Experienced an Adverse Event (AE) | 100.0 | 100.0 | 96.7 |
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that discontinued study treatment (paclitaxel, carboplatin, or MK-1775) due to an AE was reported for each treatment arm.
| percentage of participants | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin |
|---|---|---|---|
| Parts 1 and 2: Percentage of Participants That Discontinued Study Treatment Due to an AE | 20.0 | 20.3 | 21.7 |
ORR defined as the percentage of participants with best response of confirmed PR or CR based both on imaging per enhanced RECIST 1.1 and on serum marker CA-125 level according to GCIC criteria. CR defined by enhanced RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have had reduction in short axis to \<10 mm. PR was defined by enhanced RECIST 1.1 as ≥30% decrease in SOV of target lesions, taking as reference baseline SOV. Response according to CA-125 had occurred if there was ≥50% reduction in CA-125 levels from pretreatment sample. Response must have been confirmed and maintained for ≥28 days. Participants could be evaluated according to CA-125 only if they had a pretreatment sample that was ≥2 times the upper limit of normal and within 2 weeks prior to starting treatment. All randomized participants in Part 2 were analyzed. Per protocol, Part 1 participants were not included in this analysis.
| percentage of participants | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin |
|---|---|---|---|
| Part 2: ORR Per GCIG Criteria Based on Both Enhanced RECIST 1.1 and CA125 Level by Independent Radiology Review | — | 74.58 (61.6 to 85.0) | 69.35 (56.3 to 80.4) |
OS was defined as the time from randomization to death due to any cause, reported in months. Participants without documented death at the time of analysis were censored at the date last known to be alive. For this endpoint, all randomized participants in Part 2 were analyzed. Per protocol, Part 1 participants were not evaluated for OS.
| months | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin |
|---|---|---|---|
| Part 2: Median Overall Survival (OS) in Months | — | NA (20.34 to NA) | NA (NA to NA) |
Collected over Part 1: Day 1 through Post Study (286 days total). Part 2: Day 1 through Post Study (479 days total). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | — | 9/15 (60%) | 15/15 (100%) |
| Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | — | 24/59 (40.7%) | 59/59 (100%) |
| Part 2: Placebo + Paclitaxel +Carboplatin | — | 12/60 (20%) | 57/60 (95%) |
| Event | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin |
|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 3/15 | 13/59 | 2/60 |
| NeutropeniaBlood and lymphatic system disorders | 3/15 | 2/59 | 1/60 |
| DiarrhoeaGastrointestinal disorders | 2/15 | 1/59 | 1/60 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/15 | 0/59 | 1/60 |
| Sinus tachycardiaCardiac disorders | 1/15 | 0/59 | 0/60 |
| VomitingGastrointestinal disorders | 1/15 | 2/59 | 1/60 |
| Influenza like illnessGeneral disorders | 1/15 | 0/59 | 0/60 |
| Multi-organ failureGeneral disorders | 1/15 | 0/59 | 0/60 |
| CellulitisInfections and infestations | 1/15 | 0/59 | 0/60 |
| Transfusion reactionInjury, poisoning and procedural complications | 1/15 | 0/59 | 0/60 |
| Event | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 13/15 | 44/59 | 22/60 |
| NauseaGastrointestinal disorders | 13/15 | 46/59 | 36/60 |
| VomitingGastrointestinal disorders | 13/15 | 37/59 | 16/60 |
| FatigueGeneral disorders | 13/15 | 32/59 | 33/60 |
| AlopeciaSkin and subcutaneous tissue disorders | 11/15 | 32/59 | 40/60 |
| Decreased appetiteMetabolism and nutrition disorders | 8/15 | 11/59 | 11/60 |
| AnaemiaBlood and lymphatic system disorders | 6/15 | 31/59 | 19/60 |
| NeutropeniaBlood and lymphatic system disorders | 7/15 | 24/59 | 24/60 |
| PyrexiaGeneral disorders | 7/15 | 6/59 | 6/60 |
| HypomagnesaemiaMetabolism and nutrition disorders | 6/15 | 11/59 | 9/60 |
All enrolled participants
| Age, Continuous(years) | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin | Total |
|---|---|---|---|---|
| Mean | 58.2 ± 9.9 | 58.3 ± 10.1 | 60.4 ± 9.8 | 59.3 ± 9.9 |
| Sex: Female, Male(Participants) | Part 1: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: MK-1775 225 mg + Paclitaxel +Carboplatin | Part 2: Placebo + Paclitaxel +Carboplatin | Total |
|---|---|---|---|---|
| Female | 15 | 59 | 62 | 136 |
| Male | 0 | 0 | 0 | 0 |
No study locations are listed for this record.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Jul 2011 to primary completion in Aug 2016, 60 months.
Results were first posted in Sep 2017, 1 year after primary completion.
Of 104 industry-sponsored phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 51. This study's 60 months is above that.
Counting every sponsor, half of 307 studies reached it within 47 months; a quarter within 33 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adavosertib