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VS-6063

Phase 1

Ovarian Cancer | Small molecule | Oncology |Verastem, Inc.|Last Updated: Aug 12, 2024

Target and mechanism

Molecular targetFAK
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

VS-6063 · 1 trial · 1 indication

Phase 1 1
NCT03287271ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAKOvarian Cancer
RECRUITING90 Analytics
PHASE1RECRUITING
ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
4 years

Measured Via Adverse Events

Objective response rate (ORR)
4 years

ORR by RECIST 1.1.

Secondary Endpoints

To assess the toxicity and adverse event profile of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
4 years
To describe health-related quality-of-life (QoL) outcomes of patients receiving VS-6063 plus paclitaxel and carboplatin chemotherapy. (Measured Via Questionnaire)
4 years
progression free survival (PFS)
4 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Defactinib (VS-6063) +Carboplatin/PaclitaxelEXPERIMENTALDefactinib (VS-6063) +Carboplatin/Paclitaxel

Interventions

NameTypeDescription
VS-6063DRUGPhase 1: * First 3 patient cohort: VS-6063 200 mg PO twice daily * IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily, Phase 2: VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
PaclitaxelDRUGPhase 1: * First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle. * IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle. Phase 2: Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
CarboplatinDRUGPhase 1: * First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle. * IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle. Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma, diagnosed within 6 months of completing their most recent platinum-containing chemotherapy. * Patients with the following histologic cell types are eligible: Serous adenocarcinoma, endo...

Countries:United States
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Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Frequently asked questions about VS-6063

What is VS-6063 used for in ovarian cancer?

VS-6063 is an investigational small molecule being studied for the treatment of ovarian cancer. It is currently in Phase 1 clinical development, specifically being evaluated in patients with carboplatin-resistant ovarian cancer to assess its potential to re-sensitize tumors to carboplatin treatment.

What does VS-6063 target?

VS-6063 targets FAK, which is focal adhesion kinase, a protein involved in cell signaling and tumor progression. By inhibiting FAK, the drug aims to interfere with cancer cell survival and growth, potentially making resistant ovarian cancer cells more responsive to chemotherapy.

Who makes VS-6063?

VS-6063 is being developed by Verastem, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VSTM. The company is conducting clinical research to evaluate the drug's safety and efficacy in ovarian cancer.

What phase is VS-6063 in?

VS-6063 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to determine its safety, dosing, and potential effectiveness in patients with ovarian cancer.

What clinical trials is VS-6063 in?

VS-6063 is being studied in the ROCKIF Trial (NCT03287271), a Phase 1 study titled 'Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK.' This trial is recruiting 90 participants in the United States and is open to adults aged 18 years and older.

Is VS-6063 the same as defactinib?

VS-6063 is also known as defactinib, a selective inhibitor of focal adhesion kinase (FAK). In clinical trials, it is referred to by both names, and researchers use the compound to investigate its potential in overcoming resistance to carboplatin in ovarian cancer.