Not provided
Not provided
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Not provided
Sponsor decided to terminate the study
Not provided
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| Name | Class |
|---|---|
| Repare Therapeutics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to assess the safety and tolerability of RP-6306 in combination gemcitabine, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-6306 in combination with gemcitabine, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.
Phase 1, multi-center, open-label, dose-escalation study to:
The Sponsor of the study has changed from 'Repare Therapeutics' to 'Debiopharm International SA' in the United States.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose Escalation | Experimental | Multiple dose levels of RP-6306 and gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP-6306 (oral PKMYT1 inhibitor) | Drug | RP-6306 in combination with gemcitabine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With of Treatment-related Adverse Event Data Per CTCAE v5.0 Criteria to Determine Safety and Tolerability of RP-6306 in Combination With Gemcitabine. | Incidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs) | Start of treatment to 30 days post last dose. up to 1.5 years |
| Number of Dose Limiting Toxicities, as Defined Per Protocol, That Occur During the First Cycle (21 Days) of Treatment at Each Dose Level | Evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25% | During 21 days from the initiation of the study treatment (C1D1) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| # 1018, Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| # 1019, UCLA, Westwood Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine | 40 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG001 | Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine | 80 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG002 | Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine | 40 mg QD oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG003 | Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG004 | Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG005 | Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib continuously daily in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG006 | Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine | 120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG007 | Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine | 120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG008 | Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG009 | Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine | 60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG010 | Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day | 60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG011 | Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8 | 80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG012 | Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8 | 80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| FG013 | Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8 | 120 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine | 40 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG001 | Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With of Treatment-related Adverse Event Data Per CTCAE v5.0 Criteria to Determine Safety and Tolerability of RP-6306 in Combination With Gemcitabine. | Incidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs) | Posted | Count of Participants | Participants | Start of treatment to 30 days post last dose. up to 1.5 years |
|
Start of treatment to 30 days post last dose up to 1.5 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine | 40 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
Module 1a and 1b was conducted. However, Module 1c and 1d were not conducted, and the study was terminated early by the sponsor/company
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Repare Therapeutics Medical Monitor | Repare Therapeutics | 857-340-5402 | clininfo@reparerx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2023 | Aug 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2024 | Aug 8, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
Not provided
Not provided
Dose Escalation and Expansion
Not provided
Not provided
Not provided
Not provided
| Los Angeles |
| California |
| 90095 |
| United States |
| # 1017, Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| # 1022, Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| # 1023, START Midwest | Grand Rapids | Michigan | 49546 | United States |
| # 1016, Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| # 1008, Columbia University | New York | New York | 10032 | United States |
| # 1004, Memorial Sloan Kettering Cancer Institute | New York | New York | 10065 | United States |
| # 1010, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| # 2001, Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2C1 | Canada |
| # 3003, Sarah Cannon Research Institute | London | United Kingdom |
80 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG002 | Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine | 40 mg QD oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG003 | Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG004 | Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG005 | Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib continuously daily in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG006 | Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine | 120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG007 | Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine | 120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG008 | Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG009 | Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine | 60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG010 | Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day | 60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG011 | Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8 | 80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG012 | Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8 | 80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG013 | Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8 | 120 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| BG014 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
80 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle
| OG002 | Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine | 40 mg QD oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| OG003 | Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| OG004 | Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| OG005 | Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib continuously daily in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| OG006 | Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine | 120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| OG007 | Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine | 120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| OG008 | Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| OG009 | Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine | 60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| OG010 | Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day | 60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| OG011 | Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8 | 80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| OG012 | Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8 | 80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
| OG013 | Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8 | 120 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle |
|
|
| Primary | Number of Dose Limiting Toxicities, as Defined Per Protocol, That Occur During the First Cycle (21 Days) of Treatment at Each Dose Level | Evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25% | Posted | Count of Participants | Participants | During 21 days from the initiation of the study treatment (C1D1) |
|
|
|
| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| EG001 | Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine | 80 mg QD oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 5 | 7 | 3 | 7 | 7 | 7 |
| EG002 | Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine | 40 mg QD oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 3 | 4 | 2 | 4 | 4 | 4 |
| EG003 | Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib continuously daily in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 4 | 4 | 1 | 4 | 4 | 4 |
| EG004 | Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib continuously daily in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 2 | 10 | 5 | 10 | 10 | 10 |
| EG005 | Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib continuously daily in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 3 | 8 | 3 | 8 | 8 | 8 |
| EG006 | Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine | 120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 4 | 5 | 1 | 5 | 5 | 5 |
| EG007 | Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine | 120 mg QD oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 1 | 5 | 1 | 5 | 5 | 5 |
| EG008 | Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine | 40 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 3 | 4 | 2 | 4 | 4 | 4 |
| EG009 | Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine | 60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 1 | 4 | 2 | 4 | 4 | 4 |
| EG010 | Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day | 60 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 400 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 2 | 6 | 2 | 6 | 6 | 6 |
| EG011 | Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8 | 80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 2 | 4 | 2 | 4 | 4 | 4 |
| EG012 | Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8 | 80 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 600 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 1 | 3 | 1 | 3 | 3 | 3 |
| EG013 | Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8 | 120 mg BID oral (PO) lunresertib for the first 3 day per week ( 3 days on/4 days off) in combination with 800 mg/m2 intravenous (IV) gemcitabine given over 30 minutes on Day 1 and 8 of each 21-day treatment cycle | 1 | 2 | 1 | 2 | 2 | 2 |
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombotic microangiopathy | Blood and lymphatic system disorders | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | Systematic Assessment |
|
| Small intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Large intestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Obstruction gastric | Gastrointestinal disorders | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Pyelonephritis fungal | Infections and infestations | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Large intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Pelvic infection | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Embolism | Vascular disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Influenza like illness | General disorders | Systematic Assessment |
|
| Mucosal inflammation | General disorders | Systematic Assessment |
|
| Oedema peripheral | General disorders | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Candida infection | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Blood lactate dehydrogenase | Investigations | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Flushing | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |