Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Prostatic Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Patients will receive XL309 once daily in sequential cohorts of increasing doses.

Patients will receive XL309 once daily in sequential cohorts of increasing dose in combination with olaparib.

The recommended dose as determined in the Escalation Stage will be further studied in advanced solid tumor-specific cohorts.

The recommended dose as determined in the Escalation Stage will be further studied in combination with olaparib in advanced solid tumor-specific cohorts.

XL309 will be administered orally once daily.

XL309 (ISM3091)

Olaparib administered orally twice daily.

Exelixis Clinical Trials

This is a FIH, multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as PK and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in subjects with advanced solid tumors.

A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Patients With Advanced Solid Tumors

An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in Patients With Advanced Solid Tumors

To assess the safety and tolerability and to establish a preliminary RD of XL309 as monotherapy and in combination. Incidence of dose-limiting toxicities (DLTs).

Incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs). AEs and SAEs that lead to any dose modification, AEs and SAEs leading to discontinuation or deaths.

PK parameters, including AUC, Cmax, Tmax, clearance, Cmin.

To further assess the safety and tolerability of XL309 as monotherapy and in combination.

To assess preliminary efficacy of XL309 as monotherapy and in combination.

Incidence of treatment-emergent AEs, SAEs, AEs and SAEs leading to dose reduction, delay, discontinuation or deaths.

ORR per PCWG3 criteria for prostate cancer and RECIST version 1.1 for all other solid tumors as assessed by Investigator.

To characterize the PK of XL309 alone and when given in combination following a single dose administration and at a steady state after multiple dosing.

Concentration of XL309 agent and olaparib in plasma at specified time points

Concentration of XL309 and olaparib in plasma at specified time points.

Spots Global Cancer Trial Database for xl309 (ism3091)