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PARP Inhibitor

INCB001158 for Ovarian Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. day 1 of cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection
Awards & highlights

Study Summary

This trial is testing a new drug for cancer in combination with chemotherapy in people with advanced or metastatic solid tumors.

Eligible Conditions
  • Ovarian Cancer
  • Solid Tumors
  • Biliary Tract Cancer
  • Colorectal Cancer
  • Endometrial Cancer
  • Gastroesophageal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. day 1 of cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. day 1 of cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)
Phase 2: Objective Response Rate (ORR)
Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
+1 more
Secondary outcome measures
AUC0-t of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
Cmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
Cmin of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy on Cycle 2 Day 1 Following Repeated Dose Administration
+6 more

Side effects data

From 2022 Phase 1 & 2 trial • 149 Patients • NCT03314935
67%
Fatigue
50%
Diarrhoea
50%
Platelet count decreased
50%
Nausea
50%
Peripheral sensory neuropathy
33%
Decreased appetite
33%
Stomatitis
33%
Anaemia
33%
Back pain
17%
Seborrhoeic keratosis
17%
White blood cell count decreased
17%
Headache
17%
Constipation
17%
Neutrophil count decreased
17%
Dizziness
17%
Intermenstrual bleeding
17%
Lipase increased
17%
Rash maculo-papular
17%
Hyperkalaemia
17%
Epistaxis
17%
Brain oedema
17%
Cough
17%
Dysphonia
17%
Amylase increased
17%
Haemorrhage intracranial
17%
Embolism
17%
Hiccups
17%
Lip infection
17%
Oesophagitis
17%
Thrombocytopenia
17%
Gastroenteritis
17%
Abdominal pain
17%
Dermatitis acneiform
17%
Rhinitis
17%
Upper respiratory tract infection
17%
Vomiting
17%
Glaucoma
17%
Hypercholesterolaemia
17%
Dysgeusia
17%
Hyponatraemia
17%
Muscle spasms
17%
Oropharyngeal pain
17%
Tremor
17%
Tumour pain
17%
Blood alkaline phosphatase increased
17%
Blood cholesterol increased
17%
Blood creatinine increased
17%
Neutropenia
17%
Catheter site erythema
17%
Influenza like illness
17%
Insomnia
17%
Paraesthesia
17%
Taste disorder
17%
Vitreous floaters
17%
Weight decreased
17%
Neuropathy peripheral
17%
Hypoalbuminaemia
17%
Dyspepsia
17%
Hypersensitivity
17%
Abdominal discomfort
17%
Infusion related reaction
17%
Confusional state
17%
Abdominal pain upper
17%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6
Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin
Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel
Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6
Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin
Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel
Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel
Total
Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6
Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment Group CExperimental Treatment2 Interventions
INCB001158 + paclitaxel
Group II: Treatment Group BExperimental Treatment3 Interventions
INCB001158 + gemcitabine/cisplatin
Group III: Treatment Group AExperimental Treatment4 Interventions
INCB001158 + FOLFOX
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5-Fluorouracil
2012
Completed Phase 3
~7800
INCB001158
2019
Completed Phase 2
~430
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin
2005
Completed Phase 4
~5730
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,016 Total Patients Enrolled
7 Trials studying Ovarian Cancer
955 Patients Enrolled for Ovarian Cancer
Sven Gogov, MDStudy DirectorIncyte Corporation
5 Previous Clinical Trials
429 Total Patients Enrolled
Lance Leopold, MDStudy DirectorIncyte Corporation
14 Previous Clinical Trials
1,326 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What outcomes is this scientific experiment attempting to demonstrate?

"The primary endpoint of this 28-day clinical trial is the objective response rate. Other secondary endpoints are the duration of response, disease control rate, and participants with treatment-emergent adverse events (TEAEs)."

Answered by AI

Has there been prior experimentation regarding the effects of INCB001158 on individuals?

"At present, a total of 1859 clinical studies are actively researching the effects of INCB001158 and 590 have reached Phase 3. Predominately based in Guangzhou, Guangdong, there are 98115 different medical centres conducting trials for INCB001158."

Answered by AI

What indications is INCB001158 commonly prescribed for?

"The most common treatment for metastatic bladder cancer is INCB001158, which has also been proven to help patients with urinary bladder problems, advanced testicular cancer and small cell lung carcinoma."

Answered by AI

How many healthcare facilities have implemented this trial?

"Six sites are presently participating in this clinical trial. These include START San Antonio, The University of Texas MD Anderson Cancer Centre, and Northwest Georgia Oncology Centres; there is also a small collection of additional medical centres across the United States that are involved."

Answered by AI

Are there any open enrollment opportunities for this research?

"Currently, this experiment is not in search of any further volunteers. Initially posted on November 21st 2017, the trial's last update was July 20th 2022. For alternate studies involving biliary tract cancer, 2328 trials are currently recruiting and 1859 clinical trials are accepting participants for INCB001158 treatments."

Answered by AI

How many individuals can potentially partake in this medical trial?

"Presently, this trial is not recruiting any additional patients. The study was initially listed on November 21st 2017 and was last updated July 20th 2022. However, if you are searching for other trials there are currently 2328 biliary tract cancer studies and 1859 INCB001158 studies still seeking participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
2017. "A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03314935.
~20 spots leftby Apr 2025
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