Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Fulvestrant

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Participants will receive vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.

Participants will receive vevorisertib 10 mg orally QD until discontinuation or toxicity.

Participants will receive vevorisertib 20 mg orally QD until discontinuation or toxicity.

Participants will receive vevorisertib 25 mg orally QD until discontinuation or toxicity.

Participants will receive vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.

Participants will receive vevorisertib 50 mg orally QD until discontinuation or toxicity.

Participants will receive vevorisertib 75 mg orally QD until discontinuation or toxicity.

Participants will receive vevorisertib 100 mg orally QD until discontinuation or toxicity.

Participants will receive vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.

Participants will receive vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.

Participants will receive vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.

Participants will receive vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.

Administered as an oral dose every day or every other day.

Vevorisertib

Administered as an intramuscular (IM) injection.

Administered as an intravenous (IV) infusion.

Medical Director

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.

This study was terminated due to business reasons, and pharmacokinetic (PK) testing was prioritized.

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)

A Phase 1b Study of ARQ 751 as a Single Agent or in Combination With Other Anti-cancer Agents in Adult Subjects With Advanced Solid Tumors With PIK3CA / AKT / PTEN Mutations

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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 in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE.

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.

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.

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.

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 who got ≥1 dose of study drug.

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).

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-defined duration for SD. Percentage of participants with CR, PR, SD, PD, or inevaluable as a best overall response have been reported.

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 \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\].

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

The analysis population for All-Cause Mortality included all randomized participants.The analysis population for AEs included all randomized participants who received at least 1 dose of study treatment.

Participants received vevorisertib 5 mg orally once a day (QD) until discontinuation or toxicity.

Part 1: Vevorisertib 5 mg QD

Participants received vevorisertib 10 mg orally QD until discontinuation or toxicity.

Part 1: Vevorisertib 10 mg QD

Participants received vevorisertib 20 mg orally QD until discontinuation or toxicity.

Part 1: Vevorisertib 20 mg QD

Participants received vevorisertib 25 mg orally QD until discontinuation or toxicity.

Part 1: Vevorisertib 25 mg QD

Participants received vevorisertib 25 mg orally every other day (QOD) until discontinuation or toxicity.

Part 1: Vevorisertib 25 mg QOD

Participants received vevorisertib 50 mg orally QD until discontinuation or toxicity.

Part 1: Vevorisertib 50 mg QD

Participants received vevorisertib 75 mg orally QD until discontinuation or toxicity.

Part 1: Vevorisertib 75 mg QD

Participants received vevorisertib 100 mg orally QD until discontinuation or toxicity.

Part 1: Vevorisertib 100 mg QD

Participants received vevorisertib 50 mg orally QD plus paclitaxel 80 mg/m\^2 via intravenous (IV) infusion on Days 1, 7, 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.

Part 2: Vevorisertib 50 mg QD Plus Paclitaxel

Participants received vevorisertib 75 mg orally QD plus paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 7, and 15 followed by a week of rest of each 28-day cycle until discontinuation or toxicity.

Part 2: Vevorisertib 75 mg QD Plus Paclitaxel

Participants received vevorisertib 50 mg orally QD plus fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.

Part 2: Vevorisertib 50 mg QD Plus Fulvestrant

Participants received vevorisertib 75 mg orally QD plus fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until discontinuation or toxicity.

Part 2: Vevorisertib 75 mg QD Plus Fulvestrant

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Senior Vice President, Global Clinical Development

Part 1: Vevorisertib 20 mg

All participants who received at least 1 dose of study treatment.

Number of Participants Who Experience One or More Adverse Events (AEs)

Number of Participants Who Discontinue Study Treatment Due to an AE

Cycle 1 Day 1

Cycle 1 Day 22

Cycle 2 Day 1

All participants who received at least 1 dose of study drug and had ≥1 sample collected to assess Cmax at each time point. Due to termination of the study, PK testing was prioritized for dosing arms and time points that would support programmatic decision-making and subsequent clinical studies. Zero participants analyzed indicate data were not generated and no data were available.

Maximum Plasma Concentration (Cmax) of Vevorisertib

Cycle 1 Day1

All participants who received at least 1 dose of study drug and had ≥1 sample collected to assess AUC0-24 at each time point. Due to termination of the study, PK testing was prioritized for dosing arms and time points that would support programmatic decision-making and subsequent clinical studies. Zero participants analyzed indicate data were not generated and no data were available.

Area Under the Curve From 0-24 Hours (AUC0-24 Hours) of Vevorisertib

All participants who received at least 1 dose of study drug and had ≥1 sample collected to assess t1/2 at each time point. Due to termination of the study, PK testing was prioritized for dosing arms and time points that would support programmatic decision-making and subsequent clinical studies. Zero participants analyzed indicate data were not generated and no data were available.

Elimination Half-life (t½) of Vevorisertib

Number of Participants With a Dose-Limiting Toxicity (DLT), for the Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

All participants who received at least 1 dose of study treatment and had ORR data available.

Objective Response Rate (ORR)

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Progressive Disease (PD)

Inevaluable

All participants who received at least 1 dose of study treatment and had BOR data available.

Best Overall Response (BOR)

All participants who received at least 1 dose of study treatment and had DCR data available.

Disease Control Rate (DCR)

Overall Study

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Recurrence

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Anti-Infective Agents

Sirolimus

Temsirolimus

MTOR Inhibitors

Subjects in this study will receive ARQ 092 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 10 mg every other day (QOD) and will escalate until the MTD or RP2D is determined. Cycles will be repeated in four-week (28 day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.

ARQ 092

This is an open-label, Phase 1, dose escalation study of oral ARQ 092 administered to subjects with advanced solid tumors and recurrent malignant lymphoma. The study is designed to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 092 and to define a recommended Phase 2 dose of ARQ 092.

Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma

A Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma

Infections

Musculoskeletal Diseases

Diseases and Abnormalities at or Before Birth

Syndrome

Proteus Infections

Proteus Syndrome

Communicable Diseases

Enterobacteriaceae Infections

Bacterial Infections

Gram-Negative Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Hamartoma Syndrome, Multiple

Hamartoma

Neoplasms, Multiple Primary

Bone Diseases

Bone Diseases, Developmental

Congenital Abnormalities

Limb Deformities, Congenital

Musculoskeletal Abnormalities

Abnormalities, Multiple

This is a single-arm study. All study participants will be taking the experimental drug, MK-7075 (miransertib).

MK-7075 (miransertib) is a small molecule developed by ArQule Inc., a wholly owned subsidiary of Merck Sharp \&amp; Dohme, that effectively inhibits AKT. Proteus syndrome is caused by mosaic activating mutations in AKT1. This is a Phase 2 trial investigating the efficacy of miransertib as a treatment for adult and pediatric patients with Proteus syndrome.

MK-7075 (miransertib)

Christopher A Ours, M.D.

Leslie G Biesecker, M.D.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Background:

Proteus syndrome is a rare overgrowth disorder. Most people begin to have symptoms between 6 months and 2 years of age. There are very few living adults with this disease. There is also no known treatment for it. Researchers want to see if a new drug can slow down or stop overgrowth in people with Proteus syndrome.

Objective:

To learn if miransertib is a safe and effective treatment for Proteus syndrome.

Eligibility:

People ages 3 and older with Proteus syndrome

Design:

Participants will be screened with a medical checkup. They will answer questions about their medical history and current health. They will have a physical exam with vital signs. They will have an electrocardiogram to measure their heartbeat. They will give blood and urine samples. They will repeat the screening tests during the study.

Participants will take a miransertib pill once a day. They will bring their empty pill bottles with them to the NIH when they visit. If they can t swallow a pill, researchers will try to find other ways for them to take the drug.

Participants will have X-rays, ultrasounds, and imaging scans. Photos may be taken of their feet and other parts of the body that have or develop signs of Proteus syndrome.

Participants will have lung function tests to measure how much and how fast air moves out of their lungs.

Participants will complete surveys about their levels of pain, physical functioning, and quality of life.

Participants may have additional tests performed to assess their individual disease. They may have consultations with other specialists.

Participation lasts about 4 years. Participants will have 20-30 visits at the NIH....

Study Description: The primary objective of this study is to determine the response rate of miransertib as measured by the change in CCTN involvement of the plantar surface from baseline, using blinded independent central review of lesional photography in individuals with Proteus syndrome (Cohort 1). Cohorts 2 and 3 will enroll up to 30 additional patients whose non-plantar CCTN Proteus syndrome-associated lesions will be evaluated to address the secondary and exploratory study objectives. All participants will be treated with miransertib in continuous, 28-day cycles. Participants in Cohorts 1 and 2 will receive miransertib at the starting dose of 15 mg/m\^2 daily for the first three cycles, and then the dose will be increased to 25 mg/m\^2 daily, provided no clinically significant drug-related toxicity is observed. Participants in Cohort 3 will receive miransertib at the dose they were on at the time of enrollment if continuing use of miransertib or at the starting dose for Cohorts 1 and 2, not to exceed 25 mg/m\^2 daily. Safety and toxicity data will be gathered on all participants. Participants will stay on treatment for up to 52 cycles. The final clinical safety follow-up will be performed 30 days after the last dose.

Objectives:

Primary Objective: To determine the response to treatment with miransertib as measured by the growth of plantar CCTN in individuals with Proteus syndrome.

Secondary Objectives:

1. To estimate the change from baseline in pain in participants treated with miransertib
2. To estimate change from baseline in physical functioning in participants treated with miransertib
3. To estimate change from baseline in quality of life in participants treated with miransertib
4. To describe the long-term tolerability and safety of miransertib
5. To determine the duration of response in responders with respect to the primary study endpoint

Exploratory Objectives:

1. To describe the effect of miransertib on Proteus syndrome-related overgrowth manifestations assessed by imaging
2. To describe the effect of miransertib on the rate of growth of the CCTN lesion and the total lesional area (CCTN and confluent papules and nodules (pre-CCTN)) as compared to historical data from untreated participants
3. To determine if the clinical gestalt status of participants with Proteus syndrome improves on/after treatment with miransertib by comparing baseline pre-treatment gestalt to available gestalt data on/after treatment
4. To describe the effect of miransertib on d-dimer and fibrinogen levels
5. To describe the PK profile of miransertib

Endpoints:

Primary Endpoint (assessed in Cohort 1):

Change in lesional size as a proportion of the plantar surface from baseline will be used to classify each participant as either a responder or non- responder (binary) in the treated population. The primary endpoint is the response rate (defined as a \<= 5% increase in the proportion of plantar involvement from baseline after two years) as assessed by blinded central photography review.

Secondary Endpoints:

1. Change from baseline in pain score as assessed by the NRS-11 Pain Rating Scale
2. Change from baseline in physical functioning as assessed by PROMIS (Pediatric Upper Extremity Short Form 8a, Parent Proxy Upper Extremity Short Form 8a, Pediatric Mobility Short Form 8a, Parent Proxy Mobility Short Form 8a, Physical Function Short Form 8b, Parent Proxy Pain Behavior Short Form 8a)
3. Change from baseline in quality of life as assessed by the Pediatric Quality of Life Inventory (PedsQL)
4. Safety and tolerability as assessed by frequency, duration and severity of AEs from the first dose of miransertib through 30 days after the last dose of the drug (severity of AEs will be assessed by CTCAE version 5.0)
5. Time from response to failure to respond defined as having a \> 5% increase in the proportion of plantar involvement over a rolling two year period

Exploratory Endpoints:

1. Change from baseline in selected disease-related manifestations as evaluated by CT, MRI, ultrasound, and/or photography
2. Behavior of the CCTN lesion (+/- confluent papules and nodules) while on continuous treatment with miransertib using historical control data for comparison
3. Change in clinical gestalt status in treated participants using a blinded review panel and a set of pre-selected and customized endpoints for each participant
4. Change from baseline in d-dimer and fibrinogen levels
5. PK parameters (e.g., maximum plasma drug concentration \[Cmax\], time to maximum plasma drug concentration \[Tmax\], and area under the curve \[AUC\]) which are calculated from plasma concentration time data

MK-7075 (Miransertib) in Proteus Syndrome

A Multi-Cohort Phase 2 Dose-Escalation Study of MK-7075 (Miransertib) in Proteus Syndrome

Change in CCTN involvement of the plantar surface from baseline will be used to classify each subject as either a responder or non-responder (binary) in the treated population. The primary endpoint is response rate (defined as =\< 5% increase in plantar involvement from baseline over two years). This will be assessed by blinded central photography review.

Duration of response is defined as the amount of time from first response signal to progression of CCTN involvement \>5% over rolling two year intervals.

Periodic safety (e.g., physical examination, vital sign measurements, clinical laboratory tests, use of concomitant medications and collection of AE information) assessments.

Change from baseline in pain score (NRS-11), physical functioning (PROMIS), and quality of life (PedsQL).

National Human Genome Research Institute (NHGRI)

MK-7075 or miransertib (formerly ARQ 092) is small molecule that effectively inhibits AKT. Proteus syndrome is caused by mosaic activating mutations in AKT1. This is a phase I study to determine a recommended dose for subsequent trials, which will determine the efficacy of miransertib in Proteus syndrome.

Background:

Proteus syndrome (PS) is caused by a mutation in the AKT1 gene. This gene makes a protein that communicates with other proteins in the body to make cells grow. The AKT1 mutation changes chemical signals in the body and causes overgrowth. PS can be fatal. The drug MK-7075 reduces signals from the AKT1 protein. This may reduce or stabilize some of the overgrowth in people with PS. Researchers want to find the best dose of MK-7075 based on its effect on tissues in people with PS.

Objective:

To determine the safety, tolerability, and recommended dose of MK-7075 in people with PS.

Eligibility:

People ages 6 and older with PS

Design:

Participants will be screened with medical history, physical exam, and blood and urine tests.

Participants will take MK-7075 by mouth once daily for up to 12 28-day cycles.

Participants must stay near the NIH Clinical Center (CC) during the whole first cycle, for weekly visits to the CC. For cycle 2, they will have visits every 2 weeks. They will have 1 visit before cycles 3 and 4, and once before every other cycle for cycles 5 11. The final visit will be at the end of cycle 12. Visits may include:

Small skin samples taken.

ECG: Soft electrodes on the skin record heart signals.

Echocardiogram: A small probe held to the chest takes pictures of the heart.

MRI: Participants will lie in a machine that takes pictures of the body.

Joint and mobility function tests.

Participants will complete surveys by phone and in person.

Participants will keep a daily medication and symptom diary.

...

Proteus syndrome is a rare segmental overgrowth disorder caused by a somatic gain of function mutation, c.49GA, p.Glu17Lys) in the oncogene AKT1, encoding the AKT1 kinase . The disorder is progressive, with high morbidity and mortality - there are very few living adults with this disease. Tissues and cell lines from patients with Proteus syndrome harbor admixtures of mutant alleles that ranged from \<1% to approximately 50%. This mutation causes constitutive activation of AKT1, through Ser473 and Thr308 phosphorylation. This activation stimulates the AKT/PI3K pathway, mediating processes including increased cell proliferation and decreased apoptosis. The progressive nature of the disorder and the mechanism of disease (gain of function) make AKT1 an excellent target for therapeutics, specifically repression. The AKT/PI3K pathway is mutated in numerous cancers as well. Because it is commonly mutated in cancer, pharmaceutical companies are interested in targeting this molecule with inhibitors. Indeed, Proteus syndrome can be considered a simple model for cancer therapeutics, as these patients are known to harbor only a single activating mutation instead of the hundreds or thousands that are mutated in cancers. ArQule Inc., a wholly owned subsidiary of Merck \& Co., has developed a small molecule, miransertib (MK-7075) that effectively inhibits AKT, with the lowest IC50 for AKT1 (as compared to AKT2 or AKT3, and orders of magnitude lower for other kinases). This agent has undergone significant development with animal toxicity studies and is currently in phase I trials in patients with different types of cancer. In addition, we have performed in vitro testing with miransertib in cells from patients with Proteus syndrome and demonstrated reduction in AKT1 phosphorylation at doses in the range of achievable blood levels in humans with low toxicity. Because Proteus syndrome is a chronic disease, typical approaches to defining the recommended phase II dose by determining the maximum tolerated dose (MTD) are not appropriate it is unreasonable to propose that patients would tolerate significant side effects for prolonged time periods. As an initial trial for this disease, we propose a phase I study to determine a recommended dose for subsequent trials, which will determine the efficacy of miransertib in Proteus syndrome. The recommended phase II dose will be determined based on the tolerability of miransertib in children and adults with Proteus syndrome and measures of drug levels in plasma and affected tissues in patients with Proteus syndrome and measures of tissue phosphorylation of AKT1. We hypothesize that the recommended dose of miransertib will be substantially below that of doses used in patients with cancer and that this will lead to a highly favorable risk-benefit ratio on which we can base future efficacy studies.

Dose Finding Trial of MK-7075 in Children and Adults With Proteus Syndrome

Phase 1 Dose Finding Trial of MK-7075 in Children and Adults With Proteus Syndrome

Tissue drug levels are assessed at baseline, cycle 1 /day 14, and cycle 4/day 1.

Tissue tissue phospho-AKT is assessed at baseline, cycle 1/day 14, and cycle 4/day 1.

Tolerability and side effects are assessed on an ongoing basis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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)	NCT02761694	Cancer Solid Tumors	Vevorisertib Fulvestrant Paclitaxel	18 Years -	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma	NCT01473095	Solid Tumor Malignant Lymph... Tumor	ARQ 092	18 Years -	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma	NCT01473095	Solid Tumor Malignant Lymph... Tumor	ARQ 092	18 Years -	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
MK-7075 (Miransertib) in Proteus Syndrome	NCT04316546	Proteus Syndrom...	MK-7075 (mirans...	3 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Dose Finding Trial of MK-7075 in Children and Adults With Proteus Syndrome	NCT02594215	Proteus Syndrom...	MK-7075 (mirans...	6 Years - 65 Years	National Institutes of Health Clinical Center (CC)
Dose Finding Trial of MK-7075 in Children and Adults With Proteus Syndrome	NCT02594215	Proteus Syndrom...	MK-7075 (mirans...	6 Years - 65 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for akt1

Every month we try and update this database with for akt1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for akt1

Every month we try and update this database with for akt1 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for akt1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.