Metastatic Breast CancerPhase 1NCT01973309
A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer
A Phase 1 study testing Vantictumab combined with paclitaxel in people with Metastatic Breast Cancer, run by OncoMed Pharmaceuticals, Inc. at 4 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 paclitaxel. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Vantictumab combined with paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2013to Dec 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Age ≥18 years
- Histologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease
- o Patients with breast cancer overexpressing HER2 are not eligible.
- Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Show all 10Show fewer
- All acute treatment-related 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, agreement to use two effective forms of contraception
Who cannot join
- Known significant dose delays during prior treatment with a taxane due to drug-related toxicities
- Prior treatment with more than two regimens of systemic cytotoxic chemotherapy for locally recurrent or metastatic disease
- Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Cedars-Sinai Medical Center/ Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
Texas Oncology-Tyler
Tyler, Texas, 75702
About this study
Official title: A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with paclitaxel.
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 paclitaxel. Up to approximately 34 patients may be enrolled into the study.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Vantictumab combined with paclitaxel
- Keywords
- Locally Recurrent, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vantictumab combined with paclitaxelDrug
Also called (OMP-18R5)
Vantictumab combined with paclitaxel will be administered IV.
| Study group | Role | What they receive |
|---|---|---|
| Vantictumab combined with paclitaxel | Experimental | Drug: vantictumab combined with paclitaxel - administered intravenously Receives: Drug: Vantictumab combined with paclitaxel |
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 paclitaxel in patients with locally recurrent or metastatic breast cancer
The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with paclitaxel
Measured: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28 days).
Secondary outcomes (1)
Pharmacokinetics (PK) of vantictumab when administered in combination with paclitaxel to patients with locally recurrent or metastatic breast cancer
Apparent half life, AUC, clearance, volume of distribution
Measured: Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion on Days 0, 14, 56 and 70 and at the end of the vantictumab infusion with paclitaxel infusion on Days 0 and 56.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973309
- Sponsor's protocol ID
- 18R5-002
- Status last verified
- Sep 2020
- First submitted
- 25 Oct 2013
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Diamond JR, Becerra C, Richards D, Mita A, Osborne C, O'Shaughnessy J, Zhang C, Henner R, Kapoun AM, Xu L, Stagg B, Uttamsingh S, Brachmann RK, Farooki A, Mita M. Phase Ib clinical trial of the anti-frizzled antibody vantictumab (OMP-18R5) plus paclitaxel in patients with locally advanced or metastatic HER2-negative breast cancer. Breast Cancer Res Treat. 2020 Nov;184(1):53-62. doi: 10.1007/s10549-020-05817-w. Epub 2020 Aug 14.
PubMed 32803633
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 Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01973309
- Acronym / sponsor ID
- 18R5-002
- Conditions
- Metastatic Breast Cancer
- Keywords
- Locally Recurrent, Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 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 paclitaxel.
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 paclitaxel. 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
- 1
| Arm | Type | Receives |
|---|---|---|
| Vantictumab combined with paclitaxel | Experimental | Drug: Vantictumab combined with paclitaxelDrug: vantictumab combined with paclitaxel - administered intravenously |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed Informed Consent Form
- Age ≥18 years
- Histologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease
- o Patients with breast cancer overexpressing HER2 are not eligible.
- Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy
Key exclusion criteria (3 listed)
- Known significant dose delays during prior treatment with a taxane due to drug-related toxicities
- Prior treatment with more than two regimens of systemic cytotoxic chemotherapy for locally recurrent or metastatic disease
- Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment
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 |
|---|---|---|
| Vantictumab combined with paclitaxelAlso: (OMP-18R5)Vantictumab combined with paclitaxel will be administered IV. | Drug | Vantictumab combined with paclitaxel |
Primary outcome
Safety and tolerability of vantictumab in combination with paclitaxel in patients with locally recurrent or metastatic breast cancer
Time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28 days).
The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with paclitaxel
1 secondary outcome
Pharmacokinetics (PK) of vantictumab when administered in combination with paclitaxel to patients with locally recurrent or metastatic breast cancer
Time frame: Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion on Days 0, 14, 56 and 70 and at the end of the vantictumab infusion with paclitaxel infusion on Days 0 and 56.
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.
- Derived from this study: PubMed 32803633Diamond JR, Becerra C, Richards D, Mita A, Osborne C, O'Shaughnessy J, Zhang C, Henner R, Kapoun AM, Xu L, Stagg B, Uttamsingh S, Brachmann RK, Farooki A, Mita M. Phase Ib clinical trial of the anti-frizzled antibody vantictumab (OMP-18R5) plus paclitaxel in patients with locally advanced or metastatic HER2-negative breast cancer. Breast Cancer Res Treat. 2020 Nov;184(1):53-62. doi: 10.1007/s10549-020-05817-w. Epub 2020 Aug 14.
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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.
4 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 Vantictumab combined with paclitaxel in people with Metastatic Breast Cancer, run by OncoMed Pharmaceuticals, Inc. at 4 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 10 inclusion and 3 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 4 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 paclitaxel in patients with locally recurrent or metastatic breast cancer (time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973309, which also lists 1 linked publication.
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.