Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

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

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

IN10018

Placebo of IN10018

40 mg/m2 once every 4 weeks (Q4W) intravenously (IV)

Pegylated Liposomal Doxorubicin

Shangyu CHEN

Lingying WU

This is a multicenter, randomized, double-blind, phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).

This is a multicenter, randomized, double-blind, Phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).

Approximately 168 subjects will be enrolled into the study. Eligible subjects will be randomized in a 2: 1 ratio to receive IN10018 in combination with PLD treatment (Experimental Arm, N = approx. 112) or placebo of IN10018 in combination with PLD (Control Arm, N = approx. 56). Subjects will be stratified by prior bevacizumab use (yes or no) and platinum free interval (PFI, \< 3 months or 3-6 months).

Subjects will be randomized to one of following treatment arms. The investigator should follow the clinical study protocol, the approved label of these drugs and/or institutional standard of care.

* Experimental Arm: IN10018 100 mg QD orally (PO) plus PLD 40 mg/m2 once every 4 weeks (Q4W) intravenously (IV).
* Control Arm: Placebo of IN10018 100 mg QD orally (PO) plus PLD 40 mg/m2 once every 4 weeks (Q4W) intravenously (IV).

Treatment allocation/randomization will be stratified according to the following factors:

1. Prior bevacizumab use (yes or no).
2. Platinum free interval (PFI, \< 3 months or 3-6 months), 3 months is defined as 90 days.

This is a randomized, double-blind clinical study, therefore, investigator, site staff, subject, and sponsor involved in study will not know the treatment administered. In addition, the central imaging reviewer conducting the BICR evaluation will also be blinded to study treatment allocation.

IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer

A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer

Area under the concentration-time curve (AUC)

PK parameters (i.e., AUC0-τ, Cmax and Ctrough) of IN10018 and PLD, and expose-response relationship of IN10018 by population PK models.

Defined as the proportion of subjects with complete response (CR) or partial response (PR)

Defined as the proportion of patients with CR, PR, or stable disease (SD).

Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first.

The number of participants who experienced AEs is presented.

InxMed (Shanghai) Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer	NCT06014528	Ovarian Cancer ...	IN10018 Placebo of IN10... Pegylated Lipos...	18 Years -	InxMed (Shanghai) Co., Ltd.
IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer	NCT06014528	Ovarian Cancer ...	IN10018 Placebo of IN10... Pegylated Lipos...	18 Years -	InxMed (Shanghai) Co., Ltd.

Spots Global Cancer Trial Database for placebo of in10018