Solid TumorsPhase 1NCT01957007
A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC
A Phase 1 study testing Docetaxel and vantictumab in people with Solid Tumors, run by OncoMed Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with docetaxel. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Docetaxel and vantictumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2013to Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado
Aurora, Colorado, 80045
Roswell Park Cancer Center, Elm & Carlton Streets
Buffalo, New York, 14263
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: A Phase 1b Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with docetaxel.
Read the detailed description
Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with docetaxel. Up to approximately 34 patients may be enrolled into the study.
- Conditions
- Solid Tumors
- Being tested
- Docetaxel, vantictumab
- Keywords
- Phase 1, dose escalation, histologically confirmed, malignancy metastatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel will be administered IV.
vantictumabDrug
Also called (OMP-18R5)
Vantictumab will be administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Experimental | Drug: Docetaxel - administered intravenously Receives: Drug: Docetaxel; Drug: vantictumab |
| vantictumab | Experimental | Drug: vantictumab - administered intravenously Receives: Drug: Docetaxel; Drug: vantictumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)
Secondary outcomes (1)
Pharmacokinetics (PK) of vantictumab when administered in combination with docetaxel to patients with recurrent or advanced NSCLC
Apparent half life, AUC, clearance, volume of distribution
Measured: Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion and before docetaxel infusion from Day 0 to treatment termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957007
- Sponsor's protocol ID
- 18R5-004
- Status last verified
- Sep 2020
- First submitted
- 27 Sep 2013
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01957007
- Acronym / sponsor ID
- 18R5-004
- Conditions
- Solid Tumors
- Keywords
- Phase 1, dose escalation, histologically confirmed, malignancy metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with docetaxel.
Detailed description
Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with docetaxel. Up to approximately 34 patients may be enrolled into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Experimental | Drug: Docetaxel, Drug: vantictumabDrug: Docetaxel - administered intravenously |
| vantictumab | Experimental | Drug: Docetaxel, Drug: vantictumabDrug: vantictumab - administered intravenously |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelDocetaxel will be administered IV. | Drug | Docetaxel, vantictumab |
| vantictumabAlso: (OMP-18R5)Vantictumab will be administered intravenously | Drug | Docetaxel, vantictumab |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Docetaxel and vantictumab in people with Solid Tumors, run by OncoMed Pharmaceuticals, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.