Phase 2
Completed N=22
A Study of Ramucirumab and Docetaxel in Participants With Solid Tumors
Malignant Solid Tumor
Source: ClinicalTrials.gov NCT01567163 ↗
Enrolled (actual)
22
Serious AEs
50.0%
Results posted
Jun 2014
Primary outcomePrimary: Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 1 — 13.7 nanograms*hour/milliliter/milligram
Summary
The purpose of this study is to assess the effect of concomitant ramucirumab on the pharmacokinetics of docetaxel in participants with advanced malignant solid tumors.
Participants who do not complete both Cycle 1, Day 1, and Cycle 2, Day 1 according to schedule will be replaced for the purpose of analysis; these participants may continue to receive study therapy. No dose reductions, delayed or missed doses are allowed during Cycles 1 and 2.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 1 |
13.7 | — |
| PRIMARY Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 2 |
12.8 | — |
| PRIMARY Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 1 |
7.66 | — |
| PRIMARY Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 2 |
8.78 | — |
| SECONDARY Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies |
0; 0 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Docetaxel |
42400 | — |
| SECONDARY Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Docetaxel |
303.6 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has histologic or cytologic documentation of a malignant solid tumor
- Participant has an advanced solid tumor that is resistant to standard therapy or for which no standard therapy is available
- Participant has had 0-1 prior taxane-containing treatment regimens (including taxane monotherapy), which must have been completed at least 6 months before the first dose of study medication. Prior bevacizumab is allowed.
- Participant has resolution to Grade ≤ 1 (except where otherwise stated in this eligibility criteria) by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v 4.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
- Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
- Participant has adequate hematologic function (absolute neutrophil count [ANC] ≥ 1500 cells/liter (cells/L), hemoglobin ≥ 10 grams/deciliter (g/dL), and platelet count ≥ 100,000 cells/microliter (cells/mcL)]. Blood transfusion is allowed but must be completed 48 hours before study drug administration.
- Participant has adequate hepatic function (bilirubin ≤ 1.5 times the upper limit of normal [x ULN], aspartate transaminase [AST] and alanine transaminase [ALT] ≤ 1.5 x ULN)
- Participant has serum creatinine ≤ 1.5 x ULN. If serum creatinine > 1.5 x ULN, the calculated creatinine clearance [CrCl] should be ≥ 40 milliliters/minute (mL/min)
- Participant's urinary protein is <2+ on dipstick or routine urinalysis (UA) at study entry
- Participant must have adequate coagulation function as defined by an international normalized ratio (INR) of ≤ 1.5 and a partial thromboplastin time (PTT) or an activated PTT (aPTT) ≤ 1.5 x ULN
- Women with childbearing potential must have a negative serum or urine pregnancy test. Eligible participants of reproductive potential (both sexes) agree to use adequate method of contraception during the study period and for 12 weeks after the last dose of study medication.
Exclusion Criteria
- Has a known allergy or hypersensitivity to any of the treatment components
- Are currently enrolled in, or discontinued within the last 14 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Has received a therapeutic monoclonal antibody within 42 days prior to first dose of study medication
- Has received radiotherapy within 14 days prior to first dose of study medication
- Has received cytotoxic chemotherapy within 21 days prior to first dose of study medication
- Is receiving concurrent treatment with another anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy (except for androgen deprivation therapy for prostate cancer), radiation therapy, chemoembolization, targeted or other investigational anticancer therapy
- Is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other antiplatelet agents. (Aspirin use at doses up to 325 milligrams/day (mg/day) and analgesic agents with no or low bleeding risk are permitted.)
- Has a history of uncontrolled hereditary or acquired bleeding or thromboembolic disorders
- Has experienced any arterial thromboembolic event, including myocardial infarction (MI), unstable angina, stroke or transient ischemic attack (TIA), within 6 months prior to first dose of study medication
- Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to first dose of study medication
- Has experienced a Grade 3 or 4 hemorrhagic event within 3 months prior to first dose of study medication
- Has experienced peripheral neuropathy ≥ Grade 2 at any time prior to study entry
- Has a bowel obstruction, history or presence of inflammatory enteropathy or
Data sourced from ClinicalTrials.gov (NCT01567163). 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.