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Small Molecule Inhibitor
PLX2853 for Gynecologic Neoplasms
Phase 1 & 2
Waitlist Available
Research Sponsored by Plexxikon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
Age ≥18 years at the time of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of first dose until completion of long term follow-up, approximately 24 months.
Awards & highlights
Study Summary
This study is evaluating whether a drug may help treat advanced gynecological malignancies.
Eligible Conditions
- Gynecologic Neoplasms
- Ovarian Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of first dose until completion of long term follow-up, approximately 24 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of first dose until completion of long term follow-up, approximately 24 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b (PLX2853 + carboplatin combination): establish the MTD/RP2D for the combination of PLX2853 and carboplatin
Phase 2a (PLX2853 + carboplatin combination): ORR as measured by RECIST v1.1
Phase 2a (PLX2853 monotherapy): overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Secondary outcome measures
Disease control rate (DCR) (both arms)
Duration Of Response (DOR) (both arms)
Therapeutic procedure
+12 moreSide effects data
From 2008 Phase 2 trial • 149 Patients • NCT0200409359%
Nausea
59%
Diarrhoea
48%
Neutropenia
40%
Fatigue
32%
Vomiting
29%
Alopecia
27%
Constipation
25%
Decreased appetite
25%
Anaemia
24%
Abdominal pain
23%
Rash
21%
Headache
19%
Epistaxis
15%
Drug hypersensitivity
15%
Arthralgia
15%
Thrombocytopenia
15%
Neuropathy peripheral
13%
Dysgeusia
13%
Stomatitis
12%
Dizziness
12%
Dyspepsia
12%
Leukopenia
12%
Asthenia
11%
Dyspnoea
11%
Nail disorder
11%
Peripheral sensory neuropathy
9%
Mucosal inflammation
9%
Pruritus
9%
Muscle spasms
9%
Cystitis
8%
Back pain
8%
Hemorrhoids
8%
Insomnia
8%
Hypertension
8%
Pain in extremity
8%
Urinary tract infection
7%
Nasopharyngitis
7%
Cough
7%
Erythema
7%
Flushing
7%
Myalgia
7%
Bone pain
7%
Abdominal pain upper
7%
Pyrexia
7%
Chest pain
7%
Musculoskeletal pain
5%
Lethargy
5%
Dry skin
5%
Paraesthesia
5%
Abdominal pain lower
5%
Vaginal discharge
5%
Oedema peripheral
4%
Phlebitis
3%
Intestinal obstruction
1%
Abdominal distension
1%
Ascites
1%
Local swelling
1%
Pulmonary embolism
1%
Diaphragmatic hernia
1%
Cardiac failure congestive
1%
Hepatic lesion
1%
Blood glucose increased
1%
Gastrointestinal haemorrhage
1%
Lower respiratory tract infection
1%
Pneumonia
1%
Syncope
1%
Ileus paralytic
1%
Left ventricular dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy + Pertuzumab
Chemotherapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: PLX2853 Phase 2a MonotherapyExperimental Treatment1 Intervention
Up to 26 evaluable subjects with ARID1A mutation-positive advanced gynecological malignancies will be enrolled.
Group II: PLX2853 + Carboplatin Phase 1b/2a Combination TherapyExperimental Treatment2 Interventions
Phase 1b (PLX2853 + carboplatin combination): Up to 15 evaluable subjects with platinum-resistant EOC will be enrolled.
Phase 2a (PLX2853 + carboplatin combination): Up to 26 evaluable subjects with platinum-resistant EOC will be enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PLX2853
2019
Completed Phase 1
~80
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
PlexxikonLead Sponsor
24 Previous Clinical Trials
1,064 Total Patients Enrolled
Opna-IO LLCLead Sponsor
3 Previous Clinical Trials
90 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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