A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01957007 |
Recruitment Status :
Completed
First Posted : October 8, 2013
Last Update Posted : September 9, 2020
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumors | Drug: Docetaxel Drug: vantictumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 34 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer |
Study Start Date : | September 2013 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | June 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Docetaxel
Drug: Docetaxel - administered intravenously
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Drug: Docetaxel
Docetaxel will be administered IV. Drug: vantictumab Vantictumab will be administered intravenously
Other Name: (OMP-18R5) |
Experimental: vantictumab
Drug: vantictumab - administered intravenously
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Drug: Docetaxel
Docetaxel will be administered IV. Drug: vantictumab Vantictumab will be administered intravenously
Other Name: (OMP-18R5) |
- Safety and tolerability of vantictumab in combination with docetaxel in patients with recurrent or advanced NSCLC. The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly paclitaxel. [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28) ]
- Pharmacokinetics (PK) of vantictumab when administered in combination with docetaxel to patients with recurrent or advanced NSCLC [ Time Frame: Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion and before docetaxel infusion from Day 0 to treatment termination ]Apparent half life, AUC, clearance, volume of distribution

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed Informed Consent Form
- Age ≥18 years
- Histologically documented recurrent or advanced (Stage IV) NSCLC
- Eastern CooperativeOncology Group (ECOG) performance status of 0 or 1
- All acute treatmentrelated toxicity from prior therapy must have resolved to Grade ≤ 1 prior to study entry
- Adequate hematologic and end-organ function
- Evaluable or measurable disease per RECIST v1.1
- For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception
Exclusion Criteria:
- Prior treatment with docetaxel for recurrent or advanced NSCLC
- More than two regimens of systemic cytotoxic chemotherapy for recurrent or advanced NSCLC
- Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment
- Known hypersensitivity to any component of study treatments
- Grade ≥ 2 sensory neuropathy
- Uncontrolled seizure disorder or active neurologic disease
- Untreated brain metastases
- Leptomeningeal disease as a manifestation of cancer
- Active infection requiring antibiotics
- Bisphosphonate therapy for symptomatic hypercalcemia
- Known history of clinically significant liver disease, including active viral hepatitis and cirrhosis
- Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
- Pregnancy, lactation, or breastfeeding
- Known HIV infection
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Concurrent use of therapeutic warfarin
- New York Heart Association Classification III or IV (see Appendix E)
- Known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
- Osteoporosis based on a T-score of <-2.5 at the left or right total hip, left or right femoral neck or lumbar spine (L1-L4) as determined by DEXA scan
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Bone metastases and one of the following:
- Prior history of a pathologic fracture
- Lytic lesion requiring an impending orthopedic intervention
- Lack of treatment with a bisphosphonate or denosumab
- Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos® (pioglitazone), and Avandia® (rosiglitzone)
- Active treatment with an oral or IV glucocortocoid for ≥4 weeks at a daily dose equivalent to or greater than 7.5 mg of oral prednisone
- Fasting β-CTX of >1000 pg/mL
- Metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957007
United States, Colorado | |
University of Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, New York | |
Roswell Park Cancer Center, Elm & Carlton Streets | |
Buffalo, New York, United States, 14263 | |
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 |
Responsible Party: | OncoMed Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01957007 |
Other Study ID Numbers: |
18R5-004 |
First Posted: | October 8, 2013 Key Record Dates |
Last Update Posted: | September 9, 2020 |
Last Verified: | September 2020 |
Phase 1 dose escalation histologically confirmed malignancy metastatic |
Docetaxel Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |