NCT02761694 is a Phase 1 clinical trial of Vevorisertib in Cancer, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

What drugs are being tested in NCT02761694?

Interventions in NCT02761694: Vevorisertib, Fulvestrant, Paclitaxel.

What condition does NCT02761694 study?

NCT02761694 studies Cancer, Solid Tumors.

Is NCT02761694 still recruiting?

NCT02761694 is currently terminated. Last updated 6 May 2023.

Are results published for NCT02761694?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-05-06 · How we verify

NCT02761694

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Vevorisertib (ARQ 751) as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations (MK-4440-001)

Terminated Phase 1 Results posted Last updated 6 May 2023

What this trial tests

Phase 1 trial testing Vevorisertib in Cancer in 78 participants. Terminated before completion.

Timeline

26 June 2016

Primary endpoint
10 March 2021

10 March 2021

Quick facts

Lead sponsor	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	78
Start date	26 June 2016
Primary completion	10 March 2021
Estimated completion	10 March 2021
Sites	6 locations across United States

Drugs / interventions tested

Vevorisertib — full drug profile →
Fulvestrant (fulvestrant) — full drug profile →
Paclitaxel — full drug profile →

Conditions studied

Cancer — all drugs for Cancer →
Solid Tumors — all drugs for Solid Tumors →

Sponsor

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) — full company profile →

Who can join

18 and older, any sex, with Cancer or Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Experience One or More Adverse Events (AEs) Primary · Up to approximately 120 weeks

An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with study-drug treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change i

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	4
Part 1: Vevorisertib 10 mg QD	4
Part 1: Vevorisertib 20 mg	1
Part 1: Vevorisertib 25 mg QD	3
Part 1: Vevorisertib 25 mg QOD	3
Part 1: Vevorisertib 50 mg QD	3
Part 1: Vevorisertib 75 mg QD	32
Part 1: Vevorisertib 100 mg QD	8
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	5
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	5
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	3
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	6

Number of Participants Who Discontinue Study Treatment Due to an AE Primary · Up to approximately 116 weeks

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	0
Part 1: Vevorisertib 10 mg QD	1
Part 1: Vevorisertib 20 mg QD	0
Part 1: Vevorisertib 25 mg QD	0
Part 1: Vevorisertib 25 mg QOD	0
Part 1: Vevorisertib 50 mg QD	0
Part 1: Vevorisertib 75 mg QD	3
Part 1: Vevorisertib 100 mg QD	0
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	1
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	1
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	0
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	1

Maximum Plasma Concentration (Cmax) of Vevorisertib Secondary · Cycle 1 Day 1: predose and 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose; Cycle 1 Day 22: predose and 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose; Cycle 2 Day 1: predose. Cycle = 28 days.

Cmax was defined as the maximum plasma drug concentration. This study was terminated because of business reasons. Due to study termination, pharmacokinetic (PK) testing was prioritized for dosing arms and timepoints that would provide the required data to support programmatic decision-making and subsequent clinical studies. Zero participants analyzed entered in the table indicate data were not generated and no data were available. Cmax is reported as geometric mean with a percent coefficient of variation.

Cycle 1 Day 1

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	NA	± NA
Part 1: Vevorisertib 10 mg QD	4.820	± 80.1
Part 1: Vevorisertib 20 mg QD	15.3	± NA
Part 1: Vevorisertib 25 mg QD	51.39	± 68.1
Part 1: Vevorisertib 25 mg QOD	22.73	± 5.9
Part 1: Vevorisertib 50 mg QD	59.79	± 7.6
Part 1: Vevorisertib 75 mg QD	98.75	± 88.2
Part 1: Vevorisertib 100 mg QD	122.6	± 107.1
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	29.13	± 245.6
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	49.11	± 67.0
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	91.7	± NA
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	166.7	± 101.7

Cycle 1 Day 22

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	4.154	± 45.3
Part 1: Vevorisertib 10 mg QD	12.82	± 71.1
Part 1: Vevorisertib 20 mg QD	7.79	± NA
Part 1: Vevorisertib 25 mg QD	65.40	± 61.5
Part 1: Vevorisertib 25 mg QOD	19.49	± 96.5
Part 1: Vevorisertib 50 mg QD	55.15	± 76.7
Part 1: Vevorisertib 75 mg QD	225.1	± 80.0
Part 1: Vevorisertib 100 mg QD	207.7	± 80.6

Cycle 2 Day 1

Group	Value	95% CI
Part 1: Vevorisertib 75 mg QD	186.8	± 47.3
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	78.36	± 216.8
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	79.52	± 69.6
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	62.59	± 140.1
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	138.2	± 48.4

Area Under the Curve From 0-24 Hours (AUC0-24 Hours) of Vevorisertib Secondary · Cycle 1 Day 1: predose and 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose; Cycle 1 Day 22: predose and 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose; Cycle 2 Day 1: predose. Cycle = 28 days.

AUC0-24hrs was defined as area under the concentration-time curve from time 0 to 24 hours after dose administration. This study was terminated because of business reasons. Due to study termination, pharmacokinetic (PK) testing was prioritized for dosing arms and timepoints that would provide the required data to support programmatic decision-making and subsequent clinical studies. Zero participants analyzed entered in the table indicate data were not generated and no data were available. AUC0-24 is reported as geometric mean with a percent coefficient of variation.

Cycle 1 Day1

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	NA	± NA
Part 1: Vevorisertib 10 mg QD	12.27	± NA
Part 1: Vevorisertib 20 mg QD	42.2	± NA
Part 1: Vevorisertib 25 mg QD	244.1	± 113.3
Part 1: Vevorisertib 25 mg QOD	128.6	± 52.4
Part 1: Vevorisertib 50 mg QD	287.5	± 4.5
Part 1: Vevorisertib 75 mg QD	667.6	± 84.6
Part 1: Vevorisertib 100 mg QD	786.1	± 117.7
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	391.1	± NA
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	649.6	± 41.7
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	449	± NA
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	1115	± 73.5

Cycle 1 Day 22

Group	Value	95% CI
Part 1: Vevorisertib 10 mg QD	67.89	± 197.1
Part 1: Vevorisertib 20 mg QD	78.5	± NA
Part 1: Vevorisertib 25 mg QD	501.8	± 35.5
Part 1: Vevorisertib 25 mg QOD	181.2	± 59.0
Part 1: Vevorisertib 50 mg QD	543.8	± 78.2
Part 1: Vevorisertib 75 mg QD	1832	± 68.5
Part 1: Vevorisertib 100 mg QD	1786	± 82.4

Cycle 2 Day 1

Group	Value	95% CI
Part 1: Vevorisertib 75 mg QD	2013	± 66.4
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	837.2	± 200.6
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	1280	± 39.1
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	750.7	± 67.0
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	1948	± 49.7

Elimination Half-life (t½) of Vevorisertib Secondary · Cycle 1 Day 1: predose, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose; Cycle 1 Day 22: predose, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose; Cycle 2 Day 1: predose. Cycle = 28 days.

t1/2 was defined as the terminal elimination half-life of drug. This study was terminated because of business reasons. Due to study termination, pharmacokinetic (PK) testing was prioritized for dosing arms and timepoints that would provide the required data to support programmatic decision-making and subsequent clinical studies. Zero participants analyzed entered in the table indicate data were not generated and no data were available. t1/2 is reported as geometric mean with a percent coefficient of variation.

Cycle 1 Day 1

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	NA	± NA
Part 1: Vevorisertib 20 mg QD	3.68	± NA
Part 1: Vevorisertib 25 mg QD	15.43	± 104.2
Part 1: Vevorisertib 25 mg QOD	8.257	± 102.7
Part 1: Vevorisertib 50 mg QD	15.94	± 19.3
Part 1: Vevorisertib 75 mg QD	12.39	± 37.7
Part 1: Vevorisertib 100 mg QD	7.437	± 69.0
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	8.920	± NA
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	8.909	± 16.3
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	9.48	± NA
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	9.176	± 46.7

Cycle 1 Day 22

Group	Value	95% CI
Part 1: Vevorisertib 10 mg QD	10.12	± 87.0
Part 1: Vevorisertib 25 mg QD	39.33	± 48.6
Part 1: Vevorisertib 25 mg QOD	21.25	± 13.8
Part 1: Vevorisertib 50 mg QD	20.03	± 1.6
Part 1: Vevorisertib 75 mg QD	12.94	± 71.8
Part 1: Vevorisertib 100 mg QD	24.59	± 6.9

Cycle 2 Day 1

Group	Value	95% CI
Part 1: Vevorisertib 75 mg QD	22.93	± 36.8
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	20.89	± 70.9
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	28.78	± 16.3
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	11.46	± NA

Number of Participants With a Dose-Limiting Toxicity (DLT), for the Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) Secondary · Cycle 1 (Up to approximately 28 days)

DLTs consisted of hematologic or non-hematologic toxicities. Hematologic DLT was any grade (Gr) 4 anemia, Gr 4 neutropenia, Gr 4 thrombocytopenia, Gr 3 lasting \>7 days, Gr 3 thrombocytopenia in the presence of bleeding, or ≥ Gr 3 hyperglycemia. Non-hematologic DLT was any Gr 3, 4 or 5 non-hematologic toxicity with the exception of: (1) Gr 3 nausea, vomiting, diarrhea or responding to optimal medical management within 48 hours; (2) alopecia. Per protocol DLTs were analyzed in the first 28-day treatment cycle. The number of participants experiencing DLTs is reported here for all participants wh

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	0
Part 1: Vevorisertib 10 mg QD	0
Part 1: Vevorisertib 20 mg QD	0
Part 1: Vevorisertib 25 mg QD	0
Part 1: Vevorisertib 25 mg QOD	0
Part 1: Vevorisertib 50 mg QD	0
Part 1: Vevorisertib 75 mg QD	1
Part 1: Vevorisertib 100 mg QD	1
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	0
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	1
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	0
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	0

Objective Response Rate (ORR) Secondary · Up to approximately 116 weeks

ORR was defined as the percentage of participants who have best response of Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 10 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 20 mg QD	0	0.00 – 97.50
Part 1: Vevorisertib 25 mg QD	33.3	0.84 – 90.57
Part 1: Vevorisertib 25 mg QOD	0	0.00 – 70.76
Part 1: Vevorisertib 50 mg QD	0	0.00 – 84.19
Part 1: Vevorisertib 75 mg QD	4.2	0.11 – 21.12
Part 1: Vevorisertib 100 mg QD	14.3	0.36 – 57.87
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	50.0	6.76 – 93.24
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	0	0.00 – 70.76
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	0	0.00 – 84.19
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	0	0.00 – 60.24

Best Overall Response (BOR) Secondary · Up to approximately 116 weeks

BOR was assessed using RECIST 1.1. Response categories included: CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; and Inevaluable: participants who have SD as their best overall response but fail to achieve the protocol-define

Complete Response (CR)

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 10 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 20 mg QD	0	0.00 – 97.50
Part 1: Vevorisertib 25 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 25 mg QOD	0	0.00 – 70.76
Part 1: Vevorisertib 50 mg QD	0	0.00 – 84.19
Part 1: Vevorisertib 75 mg QD	0	0.00 – 14.25
Part 1: Vevorisertib 100 mg QD	0	0.00 – 40.96
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	0	0.00 – 60.24
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	0	0.00 – 70.76
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	0	0.00 – 84.19
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	0	0.00 – 60.24

Partial Response (PR)

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 10 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 20 mg QD	0	0.00 – 97.50
Part 1: Vevorisertib 25 mg QD	33.3	0.84 – 90.57
Part 1: Vevorisertib 25 mg QOD	0	0.00 – 70.76
Part 1: Vevorisertib 50 mg QD	0	0.00 – 84.19
Part 1: Vevorisertib 75 mg QD	4.2	0.11 – 21.12
Part 1: Vevorisertib 100 mg QD	14.3	0.36 – 57.87
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	50.0	6.76 – 93.24
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	0	0.00 – 70.76
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	0	0.00 – 84.19
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	0	0.00 – 60.24

Stable Disease (SD)

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 10 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 20 mg QD	100.0	2.50 – 100.00
Part 1: Vevorisertib 25 mg QD	66.7	9.43 – 99.16
Part 1: Vevorisertib 25 mg QOD	33.3	0.84 – 90.57
Part 1: Vevorisertib 50 mg QD	50.0	1.26 – 98.74
Part 1: Vevorisertib 75 mg QD	41.7	22.11 – 63.36
Part 1: Vevorisertib 100 mg QD	42.9	9.90 – 81.59
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	25.0	0.63 – 80.59
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	33.3	0.84 – 90.57
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	0	0.00 – 84.19
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	50.0	6.76 – 93.24

Progressive Disease (PD)

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	100.0	29.24 – 100.00
Part 1: Vevorisertib 10 mg QD	100.0	29.24 – 100.00
Part 1: Vevorisertib 20 mg QD	0	0.00 – 97.50
Part 1: Vevorisertib 25 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 25 mg QOD	66.7	9.43 – 99.16
Part 1: Vevorisertib 50 mg QD	50.0	1.26 – 98.74
Part 1: Vevorisertib 75 mg QD	54.2	32.82 – 74.45
Part 1: Vevorisertib 100 mg QD	28.6	3.67 – 70.96
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	0	0.00 – 60.24
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	66.7	9.43 – 99.16
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	100.0	15.81 – 100.00
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	50.0	6.76 – 93.24

Inevaluable

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 10 mg QD	0	0.00 – 0.76
Part 1: Vevorisertib 20 mg QD	0	0.00 – 97.50
Part 1: Vevorisertib 25 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 25 mg QOD	0	0.00 – 70.76
Part 1: Vevorisertib 50 mg QD	0	0.00 – 84.19
Part 1: Vevorisertib 75 mg QD	0	0.00 – 14.25
Part 1: Vevorisertib 100 mg QD	14.3	0.36 – 57.87
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	25.0	0.63 – 80.59
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	0	0.00 – 70.76
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	0	0.00 – 84.19
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	0	0.00 – 60.24

Disease Control Rate (DCR) Secondary · Up to approximately 116 weeks

DCR was defined, per RECIST 1.1, as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\].

Group	Value	95% CI
Part 1: Vevorisertib 5 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 10 mg QD	0	0.00 – 70.76
Part 1: Vevorisertib 20 mg QD	100.0	2.50 – 100.00
Part 1: Vevorisertib 25 mg QD	100.0	29.24 – 100.00
Part 1: Vevorisertib 25 mg QOD	33.3	0.84 – 90.57
Part 1: Vevorisertib 50 mg QD	50.0	1.26 – 98.74
Part 1: Vevorisertib 75 mg QD	45.8	25.55 – 67.18
Part 1: Vevorisertib 100 mg QD	57.1	18.41 – 90.10
Part 2: Vevorisertib 50 mg QD Plus Paclitaxel	75.0	19.41 – 99.37
Part 2: Vevorisertib 75 mg QD Plus Paclitaxel	33.3	0.84 – 90.57
Part 2: Vevorisertib 50 mg QD Plus Fulvestrant	0	0.00 – 84.19
Part 2: Vevorisertib 75 mg QD Plus Fulvestrant	50.0	6.76 – 93.24

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 120 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: Vevorisertib 5 mg QD

Serious: 2/4 (50%)

Deaths: 2/4

Part 1: Vevorisertib 10 mg QD

Serious: 3/4 (75%)

Deaths: 2/4

Part 1: Vevorisertib 20 mg QD

Serious: 0/1 (0%)

Deaths: 0/1

Part 1: Vevorisertib 25 mg QD

Serious: 2/3 (67%)

Deaths: 1/3

Part 1: Vevorisertib 25 mg QOD

Serious: 1/3 (33%)

Deaths: 0/3

Part 1: Vevorisertib 50 mg QD

Serious: 2/3 (67%)

Deaths: 1/3

Part 1: Vevorisertib 75 mg QD

Serious: 12/32 (38%)

Deaths: 7/33

Part 1: Vevorisertib 100 mg QD

Serious: 5/8 (63%)

Deaths: 2/8

Part 2: Vevorisertib 50 mg QD Plus Paclitaxel

Serious: 3/5 (60%)

Deaths: 2/5

Part 2: Vevorisertib 75 mg QD Plus Paclitaxel

Serious: 2/5 (40%)

Deaths: 2/5

Part 2: Vevorisertib 50 mg QD Plus Fulvestrant

Serious: 0/3 (0%)

Deaths: 1/3

Part 2: Vevorisertib 75 mg QD Plus Fulvestrant

Serious: 3/6 (50%)

Deaths: 0/6

Serious adverse events (45 terms)

Reaction	System	Part 1: Vevorisertib 5 mg QD	Part 1: Vevorisertib 10 mg…	Part 1: Vevorisertib 20 mg…	Part 1: Vevorisertib 25 mg…	Part 1: Vevorisertib 25 mg…	Part 1: Vevorisertib 50 mg…	Part 1: Vevorisertib 75 mg…	Part 1: Vevorisertib 100 m…	Part 2: Vevorisertib 50 mg…	Part 2: Vevorisertib 75 mg…	Part 2: Vevorisertib 50 mg…	Part 2: Vevorisertib 75 mg…
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—
Eyelid ptosis	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Proctalgia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Umbilical hernia, obstructive	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Disease progression	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (163 terms — click to expand)

Reaction	System	Part 1: Vevorisertib 5 mg QD	Part 1: Vevorisertib 10 mg…	Part 1: Vevorisertib 20 mg…	Part 1: Vevorisertib 25 mg…	Part 1: Vevorisertib 25 mg…	Part 1: Vevorisertib 50 mg…	Part 1: Vevorisertib 75 mg…	Part 1: Vevorisertib 100 m…	Part 2: Vevorisertib 50 mg…	Part 2: Vevorisertib 75 mg…	Part 2: Vevorisertib 50 mg…	Part 2: Vevorisertib 75 mg…
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Mucosal inflammation	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rash pruritic	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Cheilitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Ascites, Diarrhoea, Small intestinal obstruction, Anaemia, Pericardial effusion, Eyelid ptosis, Abdominal pain, Colitis.

Data from ClinicalTrials.gov NCT02761694 adverse events section.

Sponsor's own description

The primary objectives of this study are: Part 1 - Vevorisertib as single agent: To assess the safety and tolerability of vevorisertib in participants with advanced solid tumors with v-Akt murine thymoma viral oncogene homolog (AKT) 1, 2, 3 genetic alterations, activating phosphatidylinositol-3-kinase (PI3K) mutations, phosphatase and tensin homolog deleted on chromosome ten (PTEN)-null, or other known actionable PTEN mutations; Part 2 - Vevorisertib in combination with other anti-cancer agents: To assess the safety and tolerability of vevorisertib in combination with paclitaxel or fulvestrant in participants with advanced, inoperable, metastatic and/or recurrent solid tumors with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) / PTEN actionable mutations and/or AKT genetic alterations.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.
Jiang N, Dai Q, Su X, Fu J, et al · · 2020 · cited 419× · PMID 32333246 · DOI 10.1007/s11033-020-05435-1
Maximising the potential of AKT inhibitors as anti-cancer treatments.
Brown JS, Banerji U. · · 2017 · cited 184× · PMID 27919797 · DOI 10.1016/j.pharmthera.2016.12.001
Targeting PI3K/AKT/mTOR Signaling Pathway in Breast Cancer.
Li H, Prever L, Hirsch E, Gulluni F. · · 2021 · cited 132× · PMID 34298731 · DOI 10.3390/cancers13143517
A comprehensive overview of metaplastic breast cancer: clinical features and molecular aberrations.
Reddy TP, Rosato RR, Li X, Moulder S, et al · · 2020 · cited 127× · PMID 33148288 · DOI 10.1186/s13058-020-01353-z
Targeting the PI3K/AKT/mTOR pathway in epithelial ovarian cancer, therapeutic treatment options for platinum-resistant ovarian cancer.
Rinne N, Christie EL, Ardasheva A, Kwok CH, et al · · 2021 · cited 80× · PMID 35582310 · DOI 10.20517/cdr.2021.05
Next generation sequencing of vitreoretinal lymphomas from small-volume intraocular liquid biopsies: new routes to targeted therapies.
Cani AK, Hovelson DH, Demirci H, Johnson MW, et al · · 2017 · cited 68× · PMID 28002793 · DOI 10.18632/oncotarget.14008
Clinical Development of AKT Inhibitors and Associated Predictive Biomarkers to Guide Patient Treatment in Cancer Medicine.
Coleman N, Moyers JT, Harbery A, Vivanco I, et al · · 2021 · cited 46× · PMID 34858045 · DOI 10.2147/pgpm.s305068
Targeting Akt in Hepatocellular Carcinoma and Its Tumor Microenvironment.
Mroweh M, Roth G, Decaens T, Marche PN, et al · · 2021 · cited 44× · PMID 33670268 · DOI 10.3390/ijms22041794

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02761694 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Last refreshed: 6 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02761694.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02761694

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (45 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Cancer

Other ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) trials

Verify against primary sources