Table 3. Potential anti-cancer activities of CPI-613 + gemcitabine combination in patients with stage IV pancreatic cancer, based on prolonged OS when compared to the results from Phase III trials of the current most effective chemotherapies in the clinic, FOLFIRINOX and Abraxane + Gemcitabine combination.
| Patients |
Stage of pancreatic cancer | ECOG at baseline | Chemotherapy prior to CPI-613 | CPI-613 |
AE (severity gradeb) during study | Overall survival (months)c | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Identity | Race | Gender | Agea | Dose (mg/m2) | # Of cycles | |||||
| Low dose groups: median OS =5.3 | ||||||||||
| 001-106 R-A | Hispanic | Male | 50 | Stage IV | 0 | None | 70 | 1 | None | 1.5 |
| 001-107 R-D | Caucasian | Male | 62 | Stage IV | 0 | Gemzar | 105 | 1 | None | 9 |
| High dose groups: OS =17.8 | ||||||||||
| 001-110 M-C | Caucasian | Female | 64 | Stage IV | 0 | None | 150 | 1 | Stomach ache (1); swelling around eyes and nose (1); vomiting (1) | 7 |
| 001-111 B-M | Caucasian | Female | 75 | Stage IV | 0 | Gemzar; FOLFOX + Transferrin laced Oxaliplatin; 5-FU | 150 | 1 | Malaise (1); rash (2); rigors (1) | 26 |
| 001-113 M-W | African-American | Female | 76 | Stage IV | 0 | None | 190 | 2 | Headache (1); elevated G-GTP (3) | ~43 (still alive) |
| 002-107 PAK | Caucasian | Male | 64 | Stage IV | 1 | Gemzar + Tarceva; Xeloda + investigational drug | 320 | 2 | Fatigue (1); weakness (1) | 9.5 |
#, number; AE, adverse event; ECOG, Eastern Cooperative Oncology Group Performance Status; G-GTP, gamma-glutamyl transferase; a, age shown is the age at the start of the trial; b, severity grade was according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Event (CTCAE); c, survival was calculated from the start of the first chemotherapy for stage IV pancreatic cancer till death, which is the same criteria used in the FOLFIRINOX clinical trial (3) and the Abraxane + Gemcitabine combination clinical trials (4).