E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Untreated Metastatic Colorectal Cancer |
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E.1.1.1 | Medical condition in easily understood language |
Untreated Metastatic Colorectal Cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052362 |
E.1.2 | Term | Metastatic colorectal cancer |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objectives of the study is to assess whether the addition of oral veliparib to FOLFIRI will improve progression-free survival (PFS) in subjects with metastatic colorectal cancer (mCRC). |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study is to assess overall survival (OS), objective response rate (ORR), safety, and tolerability. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenetic substudy: optional blood test
Pharmacodynamic substudies: blood tests and tissue if available |
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E.3 | Principal inclusion criteria |
• ≥ 18 years of age;
• Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum;
• At least 1 unresectable lesion on a CT scan that is measurable as defined by RECIST, Version 1.1;
• ECOG performance score of 0 or 1;
• Adequate hematologic, renal and hepatic function. |
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E.4 | Principal exclusion criteria |
• Prior anti-cancer treatment for metastatic colorectal cancer;
• Prior exposure to PARP inhibitors;
• The last course of adjuvant or neoadjuvant chemotherapy must have ended > 12 months prior to C1D-2;
• Any Clinically significant and uncontrolled major medical condition;
• Subject is pregnant or lactating;
• Any medical condition, which in the opinion of the study Investigator, places the subject at an unacceptably high risk for toxicities.
• For those receiving bevacizumab, standard medical exclusionary conditions apply. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-Free Survival (PFS) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
PFS will be defined as the number of days from date of randomization to the date of earliest disease progression or death. |
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E.5.2 | Secondary end point(s) |
Overall survival (OS) and objective response rate (ORR) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
OS will be defined as the number of days from the date of randomization to the date of death. ORR will be defined as the proportion of subjects with objective response. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Performance Status (ECOG) |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Austria |
Belgium |
France |
Germany |
Hungary |
Russian Federation |
Spain |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end-of-study is defined as the date of last subject's last visit. The sponsor may also end the study upon confirmation that the primary endpoint was statistically met. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |