Head and Neck CancerPhase 1NCT01911598
A Study of MEHD7945A in Combination With Cisplatin and 5-Fluorouracil (5-FU) or Paclitaxel and Carboplatin in Participants With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)
A Phase 1 study testing 5-FU, Carboplatin and Cisplatin in people with Head and Neck Cancer, run by Genentech, Inc. at 6 sites in 2 countries.
Trial summary
This open-label, multicenter study will evaluate the safety, tolerability, and pharmacokinetics of MEHD7945A in combination with chemotherapy (either cisplatin plus 5-FU or carboplatin plus paclitaxel) in participants with previously untreated R/M SCCHN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- 5-FU, Carboplatin and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 19 Sep 2013to 22 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed R/M SCCHN of mucosal origin (e.g., oral cavity, oropharynx, hypopharynx, larynx) that is not amenable to further curative local therapy (e.g., surgery, radiation including re-irradiation) (1L R/M)
- Participants with unknown primary SCCHN presumed to be of head and neck mucosal origin are eligible if they meet all other entry criteria
- For participants who present with de novo metastatic disease, no prior systemic chemotherapy is allowed
- For participants with recurrent SCCHN, prior systemic therapy is allowed if it was given as part of induction or definitive therapy. If participants have received prior combined chemo-radiation therapy, they must be off therapy for at least 3 months
- Consent to provide archival tumor tissue for biomarker testing
- Life expectancy greater than or equal to (>/=) 12 weeks
Show all 9Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Disease that is measurable per modified RECIST v1.1
- Adequate bone marrow and organ function
Who cannot join
- Nasopharyngeal cancer
- Prior treatment with an investigational or approved agent for the purpose of inhibiting human epidermal growth factor receptor (HER) family members. This includes, but is not limited to, cetuximab, panitumumab, erlotinib, gefitinib, and lapatinib
- Prior treatment with an epidermal growth factor receptor (EGFR) inhibitor is allowed if it was administered as part of definitive therapy for locally advanced disease and completed/terminated >/= 3 months before study enrollment
- Major surgical procedure within 4 weeks prior to Day 1
- Leptomeningeal disease as the only manifestation of the current malignancy
- Active infection requiring antibiotics
Show all 20Show fewer
- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs)
- Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- Current severe, uncontrolled systemic disease
- History of cardiac heart failure of New York Heart Association Class II or greater or serious cardiac arrhythmia requiring treatment (except for atrial fibrillation and paroxysmal supraventricular tachycardia)
- History of myocardial infarction within 6 months prior to Cycle 1, Day 1, or history of unstable angina
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- History of bleeding diathesis or coagulopathy other than that due to anticoagulation therapy
- Clinically significant gastrointestinal (GI) bleeding within 6 months prior to Cycle 1, Day 1
- History of interstitial lung disease (ILD)
- History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies that required discontinuation of therapy
- Known human immunodeficiency virus (HIV) infection
- Untreated/active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- Pregnant or lactating women
- Malignancies other than SCCHN within 5 years prior to enrollment, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix or skin (e.g., melanoma in situ) or indolent prostate cancer
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
University of Colorado Cancer Center Department of Hematology
Aurora, Colorado, 80045
Massachusetts General Hospital;Hematology/ Oncology
Boston, Massachusetts, 02114
University of Chicago; Hematology/Oncology
Chicago, Illinois, 60637
Belgium3 sites
Cliniques Universitaires St-Luc
Brussels, 1200
UZ Antwerpen
Edegem, 2650
UZ Leuven Gasthuisberg
Leuven, 3000
About this study
Official title: A Phase 1b Open-Label Study of the Safety and Pharmacokinetics of MEHD7945A in Combination With Either Cisplatin and 5-FU or Paclitaxel and Carboplatin in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
This open-label, multicenter study will evaluate the safety, tolerability, and pharmacokinetics of MEHD7945A in combination with chemotherapy (either cisplatin plus 5-FU or carboplatin plus paclitaxel) in participants with previously untreated R/M SCCHN. There are two stages for each arm in this study: a Dose-limiting Toxicity (DLT)-evaluation stage (Stage I) and a cohort-expansion stage (Stage II). In Stage I, DLTs will be assessed during a DLT Assessment Window of 21 days (i.e., Cycle 1 Day 1 through Cycle 1 Day 21) for both arms. In Stage II, participants will be enrolled to further characterize the safety, pharmacokinetics, and anti-tumor activity of MEHD7945A in combination with cisplatin + 5-FU or carboplatin + paclitaxel at the identified recommended Phase II dose.
- Conditions
- Head and Neck Cancer
- Being tested
- 5-FU, Carboplatin, Cisplatin, MEHD7945A, Paclitaxel
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FUDrug
5-FU will be administered as per schedule specified in the respective arm.
CarboplatinDrug
Carboplatin will be administered as per schedule specified in the respective arm.
CisplatinDrug
Cisplatin will be administered as per schedule specified in the respective arm.
MEHD7945ADrug
Also called Duligotuzumab
MEHD7945A will be administered as per schedule specified in the respective arms.
PaclitaxelDrug
Paclitaxel will be administered as per schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| A: MEHD7945A+ Cisplatin + 5-FU | Experimental | Participants with previously untreated R/M SCCHN will receive MEHD7945A 1650 milligrams (mg) intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or protocol violation. Cisplatin will be administered as 100 milligrams per square meter (mg/m^2) IV infusion on Day 1 of Cycles 1 to 6. 5-FU will be administered as 1000 mg/m^2/day administered as continuous infusion over Days 1-4 of Cycles 1 to 6. Receives: Drug: 5-FU; Drug: Cisplatin; Drug: MEHD7945A |
| B: MEHD7945A + Paclitaxel + Carboplatin | Experimental | Participants with previously untreated R/M SCCHN will receive MEHD7945A 1650 mg IV infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or protocol violation. Carboplatin will be administered at a dose to achieve an area under the curve (AUC) of 6 milligrams/milliliter/minute (mg/mL/min) as an IV infusion on Day 1 of Cycles 1 to 6. Paclitaxel will be administered as 200 mg/m^2 IV infusion on Day 1 of Cycles 1 to 6. Receives: Drug: Carboplatin; Drug: MEHD7945A; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With DLTs
Measured: Cycle 1 Day 1 through Cycle 1 Day 21 (Cycle length = 3 weeks)
Percentage of Participants with Adverse Events
Measured: From Baseline until 45 days after last dose of study drug or until initiation of another anti-cancer therapy, withdrawal or lost to follow-up, whichever occurs first (up to approximately 3 years)
Secondary outcomes (18)
Area Under Concentration-Time Curve From Day 1 to 21 (AUC0-21d) of MEHD7945A
Measured: Pre-infusion (0 hour), 30 minutes post-infusion (infusion duration=90 minutes) on Day 1 of Cycles 1, 2, 3, 4, 8; 4 hours post-infusion on Day 1 of Cycle 1; Days 2, 4, 8, 15 of Cycle 1 (each cycle = 3 weeks)
Maximum Serum Concentration (Cmax) of MEHD7945A
Measured: 30 minutes and 4 hours post-infusion (infusion duration=90 minutes) on Day 1 of Cycle 1; 30 min post-infusion on Day 1 of Cycles 2, 3, 4, and 8 (each cycle = 3 weeks)
Minimum Serum Concentration (Cmin) of MEHD7945A
Measured: Pre-infusion (0 hour) on Day 1 of Cycles 1, 2, 3, 4, and 8 (each cycle = 3 weeks)
Cmax of Cisplatin
Measured: Pre-infusion (0 hour), 0 to 5 minutes and 1, 2, 4, 6 hours post-infusion (infusion duration = 1-2 hours) on Day 1 of Cycle 1 (Cycle length = 3 weeks)
Area Under Concentration-Time Curve From 0 to 6 Hours (AUC0-6h) of Cisplatin
Measured: Pre-infusion (0 hour), 0 to 5 minutes and 1, 2, 4, 6 hours post-infusion (infusion duration = 1-2 hours) on Day 1 of Cycle 1 (Cycle length = 3 weeks)
Plasma Concentrations of 5-FU
Measured: Pre-infusion (0 hour) on Day 1 of Cycle 1; Day 2 of Cycle 1 (Cycle length = 3 weeks)
Cmax of Carboplatin
Measured: Pre-infusion (0 hour), 0 to 5 minutes and 1, 2, 4, 6 hours post-infusion (infusion duration = 15-30 minutes) on Day 1 of Cycle 1 (Cycle length = 3 weeks)
AUC0-6h of Carboplatin
Measured: Pre-infusion (0 hour), 0 to 5 minutes and 1, 2, 4, 6 hours post-infusion (infusion duration = 15-30 minutes) on Day 1 of Cycle 1 (Cycle length = 3 weeks)
Cmax Normalized by Dose (Cmax/D) of Carboplatin
Measured: Pre-infusion (0 hour), 0 to 5 minutes and 1, 2, 4, 6 hours post-infusion (infusion duration = 15-30 minutes) on Day 1 of Cycle 1 (Cycle length = 3 weeks)
AUC0-6h Normalized by Dose (AUC0-6h/D) of Carboplatin
Measured: Pre-infusion (0 hour), 0 to 5 minutes and 1, 2, 4, 6 hours post-infusion (infusion duration = 15-30 minutes) on Day 1 of Cycle 1 (Cycle length = 3 weeks)
Cmax of Paclitaxel
Measured: Pre-infusion (0 hour), 0 to 5 minutes and 1, 3, 5 hours post-infusion (infusion duration = 3 hours) on Day 1 of Cycle 1, Day 2 of Cycle 1 (Cycle length = 3 weeks)
Area Under Concentration-Time Curve From 0 to 24 Hours (AUC0-24h) of Paclitaxel
Measured: Pre-infusion (0 hour), 0 to 5 minutes and 1, 3, 5 hours post-infusion (infusion duration = 3 hours) on Day 1 of Cycle 1, Day 2 of Cycle 1 (Cycle length = 3 weeks)
Plasma Half-Life (t1/2) of Paclitaxel
Measured: Pre-infusion (0 hour), 0 to 5 minutes and 1, 3, 5 hours post-infusion (infusion duration = 3 hours) on Day 1 of Cycle 1, Day 2 of Cycle 1 (Cycle length = 3 weeks)
Percentage of Participants With Anti-Therapeutic Antibodies to MEHD7945A
Measured: Pre-dose (0 hour) on Day 1 of Cycles 1, 4, 8 (each cycle = 3 weeks) and at study completion (approximately 3 years)
Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) as Assessed by Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: From first dose of study drug until disease progression or death (up to approximately 3 years)
Percentage of Participants With Disease Control (CR or PR or Stable Disease [SD]) as Assessed by Modified RECIST v1.1 Criteria
Measured: From first dose of study drug until disease progression or death (up to approximately 3 years)
Duration of Objective Response (CR or PR) as Assessed by Modified RECIST v1.1 Criteria
Measured: From first occurrence of CR or PR until relapse or death (up to approximately 3 years)
Progression-Free Survival as Assessed by Modified RECIST v1.1 Criteria
Measured: From first dose of study drug until disease progression or death (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study start19 Sep 2013
- Primary completion22 Jun 2017
- Study completion22 Jun 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 Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911598
- Sponsor's protocol ID
- GO28909
- Other IDs
- 2013-001285-42
- Status last verified
- Jul 2017
- First submitted
- 26 Jul 2013
- Last updated
- 6 Jul 2017
- Results posted
- No
Publications
Gerber DE, Infante JR, Gordon MS, Goldberg SB, Martin M, Felip E, Martinez Garcia M, Schiller JH, Spigel DR, Cordova J, Westcott V, Wang Y, Shames DS, Choi Y, Kahn R, Dere RC, Samineni D, Xu J, Lin K, Wood K, Royer-Joo S, Lemahieu V, Schuth E, Vaze A, Maslyar D, Humke EW, Burris HA 3rd. Phase Ia Study of Anti-NaPi2b Antibody-Drug Conjugate Lifastuzumab Vedotin DNIB0600A in Patients with Non-Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer. Clin Cancer Res. 2020 Jan 15;26(2):364-372. doi: 10.1158/1078-0432.CCR-18-3965. Epub 2019 Sep 20.
PubMed 31540980
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Open-Label Study of the Safety and Pharmacokinetics of MEHD7945A in Combination With Either Cisplatin and 5-FU or Paclitaxel and Carboplatin in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT01911598
- Acronym / sponsor ID
- GO28909
- Conditions
- Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2013 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 30 Jul 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 open-label, multicenter study will evaluate the safety, tolerability, and pharmacokinetics of MEHD7945A in combination with chemotherapy (either cisplatin plus 5-FU or carboplatin plus paclitaxel) in participants with previously untreated R/M SCCHN. There are two stages for each arm in this study: a Dose-limiting Toxicity (DLT)-evaluation stage (Stage I) and a cohort-expansion stage (Stage II). In Stage I, DLTs will be assessed during a DLT Assessment Window of 21 days (i.e., Cycle 1 Day 1 through Cycle 1 Day 21) for both arms. In Stage II, participants will be enrolled to further characterize the safety, pharmacokinetics, and anti-tumor activity of MEHD7945A in combination with cisplatin + 5-FU or carboplatin + paclitaxel at the identified recommended Phase II dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: MEHD7945A+ Cisplatin + 5-FU | Experimental | Drug: 5-FU, Drug: Cisplatin, Drug: MEHD7945AParticipants with previously untreated R/M SCCHN will receive MEHD7945A 1650 milligrams (mg) intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or protocol violation. Cisplatin will be administered as 100 milligrams per square meter (mg/m^2) IV infusion on Day 1 of Cycles 1 to 6. 5-FU will be administered as 1000 mg/m^2/day administered as continuous infusion over Days 1-4 of Cycles 1 to 6. |
| B: MEHD7945A + Paclitaxel + Carboplatin | Experimental | Drug: Carboplatin, Drug: MEHD7945A, Drug: PaclitaxelParticipants with previously untreated R/M SCCHN will receive MEHD7945A 1650 mg IV infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or protocol violation. Carboplatin will be administered at a dose to achieve an area under the curve (AUC) of 6 milligrams/milliliter/minute (mg/mL/min) as an IV infusion on Day 1 of Cycles 1 to 6. Paclitaxel will be administered as 200 mg/m^2 IV infusion on Day 1 of Cycles 1 to 6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed R/M SCCHN of mucosal origin (e.g., oral cavity, oropharynx, hypopharynx, larynx) that is not amenable to further curative local therapy (e.g., surgery, radiation including re-irradiation) (1L R/M)
- Participants with unknown primary SCCHN presumed to be of head and neck mucosal origin are eligible if they meet all other entry criteria
- For participants who present with de novo metastatic disease, no prior systemic chemotherapy is allowed
- For participants with recurrent SCCHN, prior systemic therapy is allowed if it was given as part of induction or definitive therapy. If participants have received prior combined chemo-radiation therapy, they must be off therapy for at least 3 months
- Consent to provide archival tumor tissue for biomarker testing
Key exclusion criteria (20 listed)
- Nasopharyngeal cancer
- Prior treatment with an investigational or approved agent for the purpose of inhibiting human epidermal growth factor receptor (HER) family members. This includes, but is not limited to, cetuximab, panitumumab, erlotinib, gefitinib, and lapatinib
- Prior treatment with an epidermal growth factor receptor (EGFR) inhibitor is allowed if it was administered as part of definitive therapy for locally advanced disease and completed/terminated >/= 3 months before study enrollment
- Major surgical procedure within 4 weeks prior to Day 1
- Leptomeningeal disease as the only manifestation of the current malignancy
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 |
|---|---|---|
| 5-FU5-FU will be administered as per schedule specified in the respective arm. | Drug | A: MEHD7945A+ Cisplatin + 5-FU |
| CarboplatinCarboplatin will be administered as per schedule specified in the respective arm. | Drug | B: MEHD7945A + Paclitaxel + Carboplatin |
| CisplatinCisplatin will be administered as per schedule specified in the respective arm. | Drug | A: MEHD7945A+ Cisplatin + 5-FU |
| MEHD7945AAlso: DuligotuzumabMEHD7945A will be administered as per schedule specified in the respective arms. | Drug | A: MEHD7945A+ Cisplatin + 5-FU, B: MEHD7945A + Paclitaxel + Carboplatin |
| PaclitaxelPaclitaxel will be administered as per schedule specified in the respective arm. | Drug | B: MEHD7945A + Paclitaxel + Carboplatin |
Primary outcome
Percentage of Participants With DLTs
Time frame: Cycle 1 Day 1 through Cycle 1 Day 21 (Cycle length = 3 weeks)
Percentage of Participants with Adverse Events
Time frame: From Baseline until 45 days after last dose of study drug or until initiation of another anti-cancer therapy, withdrawal or lost to follow-up, whichever occurs first (up to approximately 3 years)
18 secondary outcomes
Area Under Concentration-Time Curve From Day 1 to 21 (AUC0-21d) of MEHD7945A
Time frame: Pre-infusion (0 hour), 30 minutes post-infusion (infusion duration=90 minutes) on Day 1 of Cycles 1, 2, 3, 4, 8; 4 hours post-infusion on Day 1 of Cycle 1; Days 2, 4, 8, 15 of Cycle 1 (each cycle = 3 weeks)
Maximum Serum Concentration (Cmax) of MEHD7945A
Time frame: 30 minutes and 4 hours post-infusion (infusion duration=90 minutes) on Day 1 of Cycle 1; 30 min post-infusion on Day 1 of Cycles 2, 3, 4, and 8 (each cycle = 3 weeks)
Minimum Serum Concentration (Cmin) of MEHD7945A
Time frame: Pre-infusion (0 hour) on Day 1 of Cycles 1, 2, 3, 4, and 8 (each cycle = 3 weeks)
Cmax of Cisplatin
Time frame: Pre-infusion (0 hour), 0 to 5 minutes and 1, 2, 4, 6 hours post-infusion (infusion duration = 1-2 hours) on Day 1 of Cycle 1 (Cycle length = 3 weeks)
Area Under Concentration-Time Curve From 0 to 6 Hours (AUC0-6h) of Cisplatin
Time frame: Pre-infusion (0 hour), 0 to 5 minutes and 1, 2, 4, 6 hours post-infusion (infusion duration = 1-2 hours) on Day 1 of Cycle 1 (Cycle length = 3 weeks)
Plasma Concentrations of 5-FU
Time frame: Pre-infusion (0 hour) on Day 1 of Cycle 1; Day 2 of Cycle 1 (Cycle length = 3 weeks)
Cmax of Carboplatin
Time frame: Pre-infusion (0 hour), 0 to 5 minutes and 1, 2, 4, 6 hours post-infusion (infusion duration = 15-30 minutes) on Day 1 of Cycle 1 (Cycle length = 3 weeks)
AUC0-6h of Carboplatin
Time frame: Pre-infusion (0 hour), 0 to 5 minutes and 1, 2, 4, 6 hours post-infusion (infusion duration = 15-30 minutes) on Day 1 of Cycle 1 (Cycle length = 3 weeks)
Cmax Normalized by Dose (Cmax/D) of Carboplatin
Time frame: Pre-infusion (0 hour), 0 to 5 minutes and 1, 2, 4, 6 hours post-infusion (infusion duration = 15-30 minutes) on Day 1 of Cycle 1 (Cycle length = 3 weeks)
AUC0-6h Normalized by Dose (AUC0-6h/D) of Carboplatin
Time frame: Pre-infusion (0 hour), 0 to 5 minutes and 1, 2, 4, 6 hours post-infusion (infusion duration = 15-30 minutes) on Day 1 of Cycle 1 (Cycle length = 3 weeks)
Cmax of Paclitaxel
Time frame: Pre-infusion (0 hour), 0 to 5 minutes and 1, 3, 5 hours post-infusion (infusion duration = 3 hours) on Day 1 of Cycle 1, Day 2 of Cycle 1 (Cycle length = 3 weeks)
Area Under Concentration-Time Curve From 0 to 24 Hours (AUC0-24h) of Paclitaxel
Time frame: Pre-infusion (0 hour), 0 to 5 minutes and 1, 3, 5 hours post-infusion (infusion duration = 3 hours) on Day 1 of Cycle 1, Day 2 of Cycle 1 (Cycle length = 3 weeks)
Plasma Half-Life (t1/2) of Paclitaxel
Time frame: Pre-infusion (0 hour), 0 to 5 minutes and 1, 3, 5 hours post-infusion (infusion duration = 3 hours) on Day 1 of Cycle 1, Day 2 of Cycle 1 (Cycle length = 3 weeks)
Percentage of Participants With Anti-Therapeutic Antibodies to MEHD7945A
Time frame: Pre-dose (0 hour) on Day 1 of Cycles 1, 4, 8 (each cycle = 3 weeks) and at study completion (approximately 3 years)
Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) as Assessed by Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: From first dose of study drug until disease progression or death (up to approximately 3 years)
Percentage of Participants With Disease Control (CR or PR or Stable Disease [SD]) as Assessed by Modified RECIST v1.1 Criteria
Time frame: From first dose of study drug until disease progression or death (up to approximately 3 years)
Duration of Objective Response (CR or PR) as Assessed by Modified RECIST v1.1 Criteria
Time frame: From first occurrence of CR or PR until relapse or death (up to approximately 3 years)
Progression-Free Survival as Assessed by Modified RECIST v1.1 Criteria
Time frame: From first dose of study drug until disease progression or death (up to approximately 3 years)
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 6 Jul 2017.
- Derived from this study: PubMed 31540980Gerber DE, Infante JR, Gordon MS, Goldberg SB, Martin M, Felip E, Martinez Garcia M, Schiller JH, Spigel DR, Cordova J, Westcott V, Wang Y, Shames DS, Choi Y, Kahn R, Dere RC, Samineni D, Xu J, Lin K, Wood K, Royer-Joo S, Lemahieu V, Schuth E, Vaze A, Maslyar D, Humke EW, Burris HA 3rd. Phase Ia Study of Anti-NaPi2b Antibody-Drug Conjugate Lifastuzumab Vedotin DNIB0600A in Patients with Non-Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer. Clin Cancer Res. 2020 Jan 15;26(2):364-372. doi: 10.1158/1078-0432.CCR-18-3965. Epub 2019 Sep 20.
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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.
Clinical Trials study director
Genentech, Inc.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5-FU, Carboplatin and Cisplatin in people with Head and Neck Cancer, run by Genentech, Inc. at 6 sites in 2 countries.
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 9 inclusion and 20 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Belgium. 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?
Percentage of Participants With DLTs (time frame: Cycle 1 Day 1 through Cycle 1 Day 21 (Cycle length = 3 weeks)). The study lists 2 primary outcomes in all. 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 NCT01911598, 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 6 Jul 2017.