Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Gastrointestinal Neoplasms

Cystadenocarcinoma, Serous

Carcinosarcoma

Mixed Tumor, Mullerian

Digestive System Neoplasms

Ovarian Cancer

Ovarian Epithelial Cancer

Malignant Mixed Mullerian Tumor

Uterine Carcinosarcoma

INCB123667 will be administered at a protocol defined starting regimen once daily (QD) orally in 28-day cycles.

Subsequent dose regimens will be determined during study conduct.

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma ) will enroll in this group.

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with Endometrial/Uterine cancer will enroll in this group.

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with gastric, Gastro Esophageal Junction (GEJ), and esophageal adenocarcinomas will enroll in this group.

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with Triple Negative Breast Cancer(TNBC) will enroll in this group.

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with HR+/HER2- breast cancer who have had disease progression on or been intolerant of a CDK4/6 inhibitor will enroll in this group.

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with other tumor indications with CCNE1 amplification or cyclin E1 over-expression will enroll in this group.

INCB0123667

Incyte Corporation Call Center (US)

Incyte Corporation Call Center (ex-US)

Liz Croft Richards

This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A.

Part 1a will be dose escalation using a statistical hybrid design to identify the RDE(s), and the starting dose of INCB123667 will be 50mg QD. Part 1B is a dose expansion portion during which drug will be administered at the RDE(s) defined in Part 1A to 6 Disease Groups.

Study of INCB123667 in Subjects With Advanced Solid Tumors

A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors

Toxicities occurring during the first treatment cycle, Part 1a, will define tolerability. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.

TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Participants will receive dose reductions of INCB123667 according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.

Participants will receive dose reductions according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.

TEAE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Defines as the maximum (peak) plasma drug concentration

Defined as the time to reach maximum (peak) plasma concentration following drug administration

Ctau is defined as concentration at the end of the dosing interval

Defined as the area under the plasma concentration-time curve

Defined as the apparent total body clearance of the drug from plasma

Defined as apparent volume of distribution during terminal phase

Defined as Elimination half-life (to be used in one-or noncompartmental model)

Defined as having a best overall Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

Defined as having a best overall response of CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

Defined as the time from earliest date of disease response (Completed Rresponse or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or death due to any cause if occurring sooner than progression.

Incyte Corporation

Symptoms and General Pathology

Recurrence

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Disease Attributes

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Epithelial-myoepithelial Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Niraparib 200mg po QD day1\~21, Anlotinib 10mg po QD day1\~14

Anlotinib 10mg po QD, day1\~14, 3 weeks/cycle

Anlotinib

According to the definition of National Comprehensive Cancer Network (NCCN), ovarian clear cell carcinoma (OCCC) is a less common subtype of epithelial ovarian cancer (EOC) . The preliminary trial ANNIE (NCT04376073) shows a promising efficacy and safety profile for the ANNIE combo (anlotinib+niraparib). There is limited progress in targeted therapy for those less common ovarian cancers. In this study (CC-ANNIE), we aim to evaluate the antitumor activity and safety of niraparib combined with anlotinib in patients with platinum-resistant or platinum-refractory OCCC.

The CC-ANNIE trial is a single-arm, single-center, exploratory phase II trial. Eligible patients (≥18 \& ≤70 years) are histologically confirmed platinum-resistant recurrent OCCC and 20 subjects are planned to be enrolled. All subjects must have measurable lesions (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) and are going to be treated with niraparib 200mg once daily, anlotinib 10mg on day 1-14 of each 21-day cycle thereafter until disease progression or intolerable toxicity. The primary endpoint is the objective response rate.

Drug: Niraparib Niraparib 200mg po QD day1\~21 Drug: Anlotinib Anlotinib 10mg po QD day1\~14.

Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma.

An Open-Label, Single Arm, Phase II Trial of Niraparib in Combination With Anlotinib in Patients With Platinum-Resistant Recurrent or Platinum-Refractory Clear Cell Ovarian Cancer.

IPD for this study will be made available via the medresman site.

The primary objective of this study is to determine the preliminary efficacy of administration of niraparib in combination with anlotinib in the treatment of platinum-resistant recurrent or platinum-refractory clear cell ovarian cancer, as measured by the objective response rate (ORR), which is a combination of CR (complete response, the target lesion completely disappeared over 4 weeks) and PR (partial response, the target lesions were reduced by more than 30% for more than 4 weeks).

The frequency and severity of adverse events and toxicity based upon CTCAE version 5.0 during subjects receiving the study treatment.

Duration of response is defined as the time from the first documentation of CR or PR to the first documentation of tumor progression, or to death due to any cause.

Time to response is defined as the time from date of enrollment to the date of first documented tumor response (CR or PR).

24 weeks clinical benefit rate is defined as the rate of CR plus PR and stabel disease (SD).

The efficacy of administration of niraparib in combination with anlotinib in the homologous recombination deficient group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of INCB123667 in Subjects With Advanced Solid Tumors	NCT05238922	Solid Tumors	INCB0123667	18 Years -	Incyte Corporation
Study of INCB123667 in Subjects With Advanced Solid Tumors	NCT05238922	Solid Tumors	INCB0123667	18 Years -	Incyte Corporation
Study of INCB123667 in Subjects With Advanced Solid Tumors	NCT05238922	Solid Tumors	INCB0123667	18 Years -	Incyte Corporation
Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma.	NCT05130515	Platinum-resist...	Niraparib Anlotinib	18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma.	NCT05130515	Platinum-resist...	Niraparib Anlotinib	18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for clear cell ovarian cancer