Phase 3
Completed N=1,428
APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Nausea and vomiting · Unspecified Adult Solid Tumor, Protocol Specific
Source: ClinicalTrials.gov NCT00343460 ↗
Enrolled (actual)
1,428
Serious AEs
9.8%
Results posted
Dec 2016
Primary outcomePrimary: Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 — 160; 163; 156; 178 participants
◆ Published Evidence
Emerging
14citations · ~1 / year
Slow-release granisetron (APF530) versus palonosetron for chemotherapy-induced nausea/vomiting: analysis by American Society of Clinical Oncology emetogenicity criteria.
Summary
This randomized phase III trial is studying APF530 and dexamethasone to see how well they work compared with palonosetron and dexamethasone in preventing nausea and vomiting in patients receiving chemotherapy for cancer.
Linked Publications (2)
-
Slow-release granisetron (APF530) versus palonosetron for chemotherapy-induced nausea/vomiting: analysis by American Society of Clinical Oncology emetogenicity criteria.
-
Randomized phase III trial of APF530 versus palonosetron in the prevention of chemotherapy-induced nausea and vomiting in a subset of patients with breast cancer receiving moderately or highly emetogenic chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 |
160; 163; 156; 178; 195; 192 | — |
| PRIMARY Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 |
110; 125; 120; 148; 164; 158 | — |
| SECONDARY Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1 |
154; 152; 147; 170; 183; 184 | — |
| SECONDARY Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1 |
135; 121; 113; 141; 146; 158 | — |
| SECONDARY Number of Emetic Episodes |
3.4; 3.1; 2.1; 2.3; 2.4; 2.5 | — |
| SECONDARY Time to First Treatment Failure |
0.738; 0.763; 0.755; 0.781; 0.811; 0.803 | — |
| SECONDARY First and Overall Use of Rescue Medication |
42; 37; 41; 35; 23; 25 | — |
| SECONDARY Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours) |
78; 85; 66; 105; 102; 121 | — |
| SECONDARY Sustainability of Antiemetic Effect of APF530 Over Multiple Chemotherapy Courses |
34; 35; 56; 52 | — |
| SECONDARY Quality of Life and the Impact of Nausea and Vomiting on Day 5 |
112; 127; 120; 142; 142; 159 | — |
| SECONDARY Patient's Global Satisfaction With Antiemetic Therapy During Acute Phase and Chemotherapy Course 1 |
101; 113; 98; 128; 128; 135 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignant disease
- No head and neck cancer or upper gastrointestinal cancer
- Scheduled to receive a single day of moderately or highly emetogenic chemotherapy regimen (for ≤ 4 courses)
- Chemotherapy administration ≤ 4 hours
- Duration of each course ≤ 28 days
- Causing nausea and vomiting in 30-100% of patients if untreated according to Hesketh algorithm
- Must be able to receive standardized doses of dexamethasone for the prevention of emesis during study treatment
- No greater than mild nausea or any vomiting within 24 hours before beginning study treatment
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known allergy or hypersensitivity to other selective 5-HT3 receptor antagonists or local anesthetics
- QTc interval ≤ 500 ms
- No cardiac abnormality predisposing the patient to arrhythmia
- No psychological problem that, in the opinion of the investigator, is severe enough to preclude study participation
- No recent history (i.e., ≤ 1 year) of alcohol or drug abuse
- No concurrent condition that, in the opinion of the investigator, could affect assessment of study medication or interfere with the nausea/vomiting response (e.g., severe renal or hepatic impairment)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No radiotherapy 7 days prior to, during, and 5 days after completion of study treatment
- More than 7 days since prior chemotherapy
- More than 7 days since prior and no concurrent prohibited medications (e.g., CYP3A4 inhibitors or other antiemetic medications)
- More than 7 days since prior antinausea medications
- More than 30 days since prior treatment on an investigational trial
- No other concurrent corticosteroids or dexamethasone at a different dose than study treatment
- No concurrent use of APF530, palonosetron hydrochloride, or aprepitant as rescue medications
Data sourced from ClinicalTrials.gov (NCT00343460) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.