NeoplasmsPhase 1IMYO29233NCT02825940
A Study to Assess the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Administered Intravenously (IV) as a Single Agent or in Combination With Chemotherapy in Chinese Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing Atezolizumab, Gemcitabine and Cisplatin in people with Neoplasms, run by Hoffmann-La Roche at 7 sites in China.
Trial summary
This Phase I, open-label, multicenter study will evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of atezolizumab as monotherapy in Chinese participants with locally advanced or metastatic gastric cancer, nasopharyngeal cancer, esophageal cancer, and hepatocellular carcinoma (HCC) that are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Atezolizumab, Gemcitabine and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesChina
- Study dates
- 4 Aug 2016to 4 Nov 2022
- 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 documented, incurable or metastatic solid tumor that is advanced (non-resectable) or recurrent and progressing since the last the anti-tumor therapy and for which no recognized standard curative therapy exists or who have refused the standard therapy
- Adequate hematologic and end organ function
- Measurable disease per RECIST v1.1 or mRECIST
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Women who are not postmenopausal (greater than or equal to (>=) 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment
- A representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in paraffin block (preferred) or 15 or more unstained, freshly cut, serial sections (on slides) from an FFPE tumor specimen is required for participation in this study. This specimen must be accompanied by the pathology report
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- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (<) 1% per year during the treatment period and for at least 90 days 5 months after the last dose of atezolizumab, or 6 months after the last dose of cisplatin or gemcitabine, whichever is longer, if combined. Women must refrain from donating eggs during this same period
- For men in the NSCLC cohort only: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm
- For participants in the NSCLC Cohort: Histologically or cytologically confirmed Stage IV NSCLC (per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system)
- For participants in the NSCLC Cohort: No prior chemotherapy for Stage IV NSCLC
- For participants in the NSCLC Cohort: Participants who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from enrollment since the last chemotherapy, radiotherapy, or chemoradiotherapy cycle
Who cannot join
- Pregnant or lactating
- Any approved anti-cancer therapy, including chemotherapy, targeted therapy or hormonal therapy less than (<) 5 half-lives prior to initiation of study treatment
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- Uncontrolled hypercalcemia (greater than (>) 1.5 millimoles per liter (mmol/L) ionized calcium or calcium >12 milligram per deciliter (mg/dL) or corrected serum calcium greater than the upper limit of normal) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease, uncontrolled major seizure disorder, or superior vena cava syndrome
- Participants with acute leukemia, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma
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- Symptomatic, actively progressing, or untreated central nervous system metastases as determined by computed tomography or magnetic resonance imaging evaluation during screening and prior radiographic assessments
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Participants with prior allogenic stem cell or solid organ transplantation
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk from treatment complications
- Positive test for HIV
- Participants with active hepatitis B infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C infection (for the non-HCC cohorts only)
- For participants in the NSCLC Cohort: Known tumor programmed death-ligand 1 (PD-L1) expression status as determined by an immunohistochemistry assay during participation in other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-programmed death 1 or anti-PD-L1 antibodies but were not eligible are excluded)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Cancer Hospital
Beijing, 100142
Jilin Cancer Hospital
Changchun, 132013
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
Guangzhou, 510060
Sir Run Run Shaw Hospital
Hangzhou, 310018
Harbin Medical University Cancer Hospital
Harbin, 150081
Zhongshan Hospital Fudan University
Shanghai, 200032
Fudan University Shanghai Cancer Center
Shanghai, 200120
About this study
Official title: A Phase I, Open-Label Study to Assess the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Administered Intravenously as a Single Agent or in Combination With Chemotherapy in Chinese Patients With Locally Advanced or Metastatic Solid Tumors
This Phase I, open-label, multicenter study will evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of atezolizumab as monotherapy in Chinese participants with locally advanced or metastatic gastric cancer, nasopharyngeal cancer, esophageal cancer, and hepatocellular carcinoma (HCC) that are refractory to standard therapeutic modalities and for whom no further standard therapy is available or who have refused standard therapy; and the safety and preliminary anti-tumor activity of atezolizumab in combination with gemcitabine and cisplatin in Chinese participants with Stage IV, treatment-naive non-small cell lung cancer (NSCLC). The study will consist of a pharmacokinetic (PK) phase and an extension phase.
- Conditions
- Neoplasms
- Being tested
- Atezolizumab, Gemcitabine, Cisplatin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called MPDL3280A, RO5541267
Atezolizumab will be administered at a dose of 1200 mg IV q3w (in 21-day cycles), except for participants with NSCLC who will be administered atezolizumab at a dose of 1200 mg IV on Day 1.
GemcitabineDrug
Gemcitabine will be administered to participants with NSCLC at a dose of 1250 mg/m^2 on Days 1 and 8.
CisplatinDrug
Cisplatin will be administered to participants with NSCLC at a dose of 75 mg/m^2 on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab Monotherapy: PK and Extension Phases | Experimental | Participants during the PK and extension phases of the study will receive atezolizumab alone at a dose of 1200 milligrams (mg) IV every 3 weeks (q3w) (in 21-day cycles) continuously until loss of clinical benefit, disease progression, unacceptable toxicity, participant or physician decision to discontinue, or death. Study treatment may continue beyond disease progression based on the investigator's discretion. Receives: Drug: Atezolizumab |
| Atezolizumab and Chemotherapy: Extension Phase | Experimental | Participants during the extension phase of the study will receive atezolizumab at a dose of 1200 mg IV on Day 1 in combination with gemcitabine at a dose of 1250 milligrams per square meter (mg/m^2) on Days 1 and 8 and cisplatin at a dose of 75 mg/m^2 on Day 1 (four or six 21-day cycles at the discretion of the investigator), followed by atezolizumab as a single agent at a dose of 1200 mg IV q3w on Day 1 of a 21-day cycle) as maintenance treatment continuously until loss of clinical benefit, disease progression, unacceptable toxicity, participant or physician decision to discontinue, or death. Study treatment may continue beyond disease progression based on the investigator's discretion. Receives: Drug: Atezolizumab; Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Atezolizumab
Measured: Pre-dose (0 hours [h]), 0.5h post-dose (PtD) at Day (D) 1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Minimum Observed Plasma Concentration (Cmin) of Atezolizumab
Measured: Pre-dose (0h), 0.5h PtD at D1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Accumulation Ratio (R) of Atezolizumab Based on Concentrations After the First Dose and at Steady State
Measured: Pre-dose (0h), 0.5h PtD at D 1; D2, 4, 8, 15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Area Under the Plasma Concentration-Time Curve (AUC) of Atezolizumab (PK phase only)
Measured: Pre-dose (0h), 0.5h PtD at D 1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Systemic Clearance (CL) of Atezolizumab (PK phase only)
Measured: Pre-dose (0h), 0.5h PtD at D1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Volume of Distribution at Steady State (Vss) of Atezolizumab (PK phase only)
Measured: Pre-dose (0h), 0.5h PtD at D1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Terminal Half-Life (t1/2) of Atezolizumab (PK phase only)
Measured: Pre-dose (0h), 0.5h PtD at D1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Objective Response (OR), Defined as a Complete Response (CR) or Partial Response (PR) on Two Consecutive Occasions >/= 4 Weeks Apart, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: From the first occurrence of a PR or CR through the end of study (maximum up to 3 years)
Secondary outcomes (7)
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Measured: From the first occurrence of a documented OR to the first occurrence of disease progression, whichever occurs first (maximum up to 3 years)
Time to Progression (TTP) (HCC Cohort) as Determined by the Investigator According to RECIST v1.1
Measured: From the first dose of atezolizumab (Day 1) to the first occurrence of disease progression (maximum up to 3 years)
Progression-free Survival (PFS) as Determined by the Investigator According to RECIST v1.1
Measured: From the first dose of atezolizumab (Day 1) to the first occurrence of disease progression or death, whichever comes first (maximum up to 3 years)
Overall survival (OS)
Measured: From the first dose of atezolizumab (Day 1) to death from any cause (maximum up to 3 years)
OS at 6 Months and 1 Year
Measured: 6 Months; 1 Year
Percentage of Participants with Adverse Events (AE)
Measured: From baseline through the end of study (maximum up to 3 years)
Percentage of Participants with Anti-Therapeutic Antibodies (ATA) to Atezolizumab
Measured: From first dose of atezolizumab (Day 1) through the end of study (maximum up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start4 Aug 2016
- Primary completion14 Jan 2020
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825940
- Sponsor's protocol ID
- YO29233
- Acronym
- IMYO29233
- Status last verified
- Jan 2023
- First submitted
- 5 Jul 2016
- Last updated
- 4 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study to Assess the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Administered Intravenously as a Single Agent or in Combination With Chemotherapy in Chinese Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT02825940
- Acronym / sponsor ID
- IMYO29233 / YO29233
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2016 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 7 Jul 2016 (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 Phase I, open-label, multicenter study will evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of atezolizumab as monotherapy in Chinese participants with locally advanced or metastatic gastric cancer, nasopharyngeal cancer, esophageal cancer, and hepatocellular carcinoma (HCC) that are refractory to standard therapeutic modalities and for whom no further standard therapy is available or who have refused standard therapy; and the safety and preliminary anti-tumor activity of atezolizumab in combination with gemcitabine and cisplatin in Chinese participants with Stage IV, treatment-naive non-small cell lung cancer (NSCLC). The study will consist of a pharmacokinetic (PK) phase and an extension phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab Monotherapy: PK and Extension Phases | Experimental | Drug: AtezolizumabParticipants during the PK and extension phases of the study will receive atezolizumab alone at a dose of 1200 milligrams (mg) IV every 3 weeks (q3w) (in 21-day cycles) continuously until loss of clinical benefit, disease progression, unacceptable toxicity, participant or physician decision to discontinue, or death. Study treatment may continue beyond disease progression based on the investigator's discretion. |
| Atezolizumab and Chemotherapy: Extension Phase | Experimental | Drug: Atezolizumab, Drug: Gemcitabine, Drug: CisplatinParticipants during the extension phase of the study will receive atezolizumab at a dose of 1200 mg IV on Day 1 in combination with gemcitabine at a dose of 1250 milligrams per square meter (mg/m^2) on Days 1 and 8 and cisplatin at a dose of 75 mg/m^2 on Day 1 (four or six 21-day cycles at the discretion of the investigator), followed by atezolizumab as a single agent at a dose of 1200 mg IV q3w on Day 1 of a 21-day cycle) as maintenance treatment continuously until loss of clinical benefit, disease progression, unacceptable toxicity, participant or physician decision to discontinue, or death. Study treatment may continue beyond disease progression based on the investigator's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically documented, incurable or metastatic solid tumor that is advanced (non-resectable) or recurrent and progressing since the last the anti-tumor therapy and for which no recognized standard curative therapy exists or who have refused the standard therapy
- Adequate hematologic and end organ function
- Measurable disease per RECIST v1.1 or mRECIST
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Women who are not postmenopausal (greater than or equal to (>=) 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment
Key exclusion criteria (13 listed)
- Pregnant or lactating
- Any approved anti-cancer therapy, including chemotherapy, targeted therapy or hormonal therapy less than (<) 5 half-lives prior to initiation of study treatment
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- Uncontrolled hypercalcemia (greater than (>) 1.5 millimoles per liter (mmol/L) ionized calcium or calcium >12 milligram per deciliter (mg/dL) or corrected serum calcium greater than the upper limit of normal) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease, uncontrolled major seizure disorder, or superior vena cava syndrome
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 |
|---|---|---|
| AtezolizumabAlso: MPDL3280A, RO5541267Atezolizumab will be administered at a dose of 1200 mg IV q3w (in 21-day cycles), except for participants with NSCLC who will be administered atezolizumab at a dose of 1200 mg IV on Day 1. | Drug | Atezolizumab Monotherapy: PK and Extension Phases, Atezolizumab and Chemotherapy: Extension Phase |
| GemcitabineGemcitabine will be administered to participants with NSCLC at a dose of 1250 mg/m^2 on Days 1 and 8. | Drug | Atezolizumab and Chemotherapy: Extension Phase |
| CisplatinCisplatin will be administered to participants with NSCLC at a dose of 75 mg/m^2 on Day 1. | Drug | Atezolizumab and Chemotherapy: Extension Phase |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Atezolizumab
Time frame: Pre-dose (0 hours [h]), 0.5h post-dose (PtD) at Day (D) 1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Minimum Observed Plasma Concentration (Cmin) of Atezolizumab
Time frame: Pre-dose (0h), 0.5h PtD at D1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Accumulation Ratio (R) of Atezolizumab Based on Concentrations After the First Dose and at Steady State
Time frame: Pre-dose (0h), 0.5h PtD at D 1; D2, 4, 8, 15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Area Under the Plasma Concentration-Time Curve (AUC) of Atezolizumab (PK phase only)
Time frame: Pre-dose (0h), 0.5h PtD at D 1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Systemic Clearance (CL) of Atezolizumab (PK phase only)
Time frame: Pre-dose (0h), 0.5h PtD at D1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Volume of Distribution at Steady State (Vss) of Atezolizumab (PK phase only)
Time frame: Pre-dose (0h), 0.5h PtD at D1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Terminal Half-Life (t1/2) of Atezolizumab (PK phase only)
Time frame: Pre-dose (0h), 0.5h PtD at D1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)
Objective Response (OR), Defined as a Complete Response (CR) or Partial Response (PR) on Two Consecutive Occasions >/= 4 Weeks Apart, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: From the first occurrence of a PR or CR through the end of study (maximum up to 3 years)
7 secondary outcomes
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Time frame: From the first occurrence of a documented OR to the first occurrence of disease progression, whichever occurs first (maximum up to 3 years)
Time to Progression (TTP) (HCC Cohort) as Determined by the Investigator According to RECIST v1.1
Time frame: From the first dose of atezolizumab (Day 1) to the first occurrence of disease progression (maximum up to 3 years)
Progression-free Survival (PFS) as Determined by the Investigator According to RECIST v1.1
Time frame: From the first dose of atezolizumab (Day 1) to the first occurrence of disease progression or death, whichever comes first (maximum up to 3 years)
Overall survival (OS)
Time frame: From the first dose of atezolizumab (Day 1) to death from any cause (maximum up to 3 years)
OS at 6 Months and 1 Year
Time frame: 6 Months; 1 Year
Percentage of Participants with Adverse Events (AE)
Time frame: From baseline through the end of study (maximum up to 3 years)
Percentage of Participants with Anti-Therapeutic Antibodies (ATA) to Atezolizumab
Time frame: From first dose of atezolizumab (Day 1) through the end of study (maximum up to 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 4 Jan 2023.
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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
Hoffmann-La Roche
7 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 Atezolizumab, Gemcitabine and Cisplatin in people with Neoplasms, run by Hoffmann-La Roche at 7 sites in China.
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 11 inclusion and 13 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 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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?
Maximum Observed Plasma Concentration (Cmax) of Atezolizumab (time frame: Pre-dose (0 hours [h]), 0.5h post-dose (PtD) at Day (D) 1; D2,4,8,15 of C1; pre-dose (-2h), 0.5h PtD at D1 of C2,3,4,8,12,16, thereafter every eight cycles until treatment discontinuation or 120 days after last dose (maximum up to 3 years)). The study lists 8 primary outcomes in all. 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 4 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.