Advanced Renal Cell CarcinomaPhase 2NCT01727336
Study of Dalantercept and Axitinib in Patients With Advanced Renal Cell Carcinoma
A Phase 2 study testing Dalantercept and axitinib in people with Advanced Renal Cell Carcinoma, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA at 36 sites in United States.
Trial summary
The purpose of Part 1 of this study is to evaluate the safety and tolerability of dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (RCC) to determine the recommended dose level of dalantercept in combination with axitinib for Part 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma
- What is being tested?
- Dalantercept and axitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 36 sitesUnited States
- Study dates
- Dec 2012to Nov 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, advanced, predominantly clear cell renal cell carcinoma (RCC).
- Part 1: Progression of disease following up to three lines of prior therapy, including at least one approved VEGF receptor tyrosine kinase inhibitor for RCC. Adjuvant therapy is permitted as one line of prior therapy.
- Part 2: Progression of disease following one VEGF pathway inhibitor for RCC (e.g. sunitinib, pazopanib, sorafenib, bevacizumab, tivozanib, or cabozantinib) inclusive of adjuvant therapy if there was documented disease progression during treatment. Patients may have received one additional line of an approved mTOR kinase inhibitor (e.g. everolimus, temsirolimus). Prior exposure to investigational and/or approved anticancer immune therapies is permitted.
- A minimum of 1 week since the last dose of prior therapy (a minimum of 4 weeks since anticancer immune therapy or bevacizumab +/- interferon).
- Measurable disease that is evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Clinical laboratory values within acceptable ranges within 72 hours prior to study day 1.
Who cannot join
- Clinically significant organ/system disease unrelated to RCC that in the judgment of the investigator should preclude treatment with dalantercept or axitinib.
- Clinically significant cardiovascular risk.
- Known CNS metastases or leptomeningeal disease:
- For Part 1, patients with CNS metastases treated with whole brain radiotherapy, gamma knife, and/or surgery who are considered stable by CNS imaging and are not being treated with corticosteroids 6 weeks prior to study day 1 may be enrolled.
- For Part 2, patients with CNS metastases treated stereotactic radio-surgery (SRS), and/or surgery who are considered stable by CNS imaging for at least 2 months prior to enrollment and are not being treated with corticosteroids 6 weeks prior to study day 1 may be enrolled.
- Any active malignancy, other than RCC, for which chemotherapy or other anti-cancer therapy is indicated. Patients with adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 3 years will be permitted.
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- Any lesion invading or having encasement ≥ 180 degrees around the wall of a major blood vessel as assessed by computed tomography (CT) scan and/or magnetic resonance imaging (MRI).
- Radiotherapy within 2 weeks prior to study day 1.
- Lack of recovery from toxic effects of previous treatment for RCC ≤ grade 1 with the exception of alopecia, unless stabilized under adequate medical control.
- Patients undergoing renal dialysis.
- Major surgery within 4 weeks prior to study day 1 (patients must have recovered completely from any previous surgery prior to study day 1).
- Any active infection requiring antibiotic therapy within 2 weeks of study day 1.
- Anti-coagulation therapy. Aspirin, other anti-platelet agents, and low molecular weight heparin are permitted unless the investigator deems the patient is at a significant risk for bleeding.
- Current use or anticipated inability to avoid potent CYP3A4/5 inhibitors or inducers (please refer to the Inlyta® [axitinib] prescribing information) during participation in the study.
- Peripheral edema requiring medical intervention within 2 weeks prior to study day 1.
- Bleeding diathesis including clinically significant platelet disorders or active hemoptysis (defined as bright red blood of ≥ 1/2 teaspoon [2.5 mL] in any 24 hour period) within 6 months prior to study day 1. For clinically significant epistaxis within 4 weeks prior to study day 1, no risk of further bleeding must be clearly documented.
- Known history of hereditary hemorrhagic telangiectasia (HHT).
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections or positive human immunodeficiency virus (HIV) antibody results. Patients with sustained virologic response to HCV treatment or immunity to HBV from prior infection without cirrhosis may be included.
- History of severe (defined as ≥ grade 3, using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 [NCI-CTCAE] v4 current active minor version) allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients (10 mM Tris buffered saline) in the investigational agent.
- Any prior treatment with dalantercept or any other agent targeting ALK1 pathway.
- Any prior treatment with axitinib.
- A morbidity (per the prescribing information) that would require starting a patient at a reduced dose of axitinib.
- Treatment with another investigational drug (with the exception of anticancer immune therapy) or device, or approved therapy for investigational use, within 5 times the half-life of the drug or within 3 weeks prior to study day 1 if the half life is not known.
- Pregnant or lactating female patients.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
New York Oncology Hematology, P.C.
Albany, New York
University of New Mexico
Albuquerque, New Mexico
Rocky Mountain Cancer Centers
Aurora, Colorado
Texas Oncology-South Austin
Austin, Texas
Saint Luke's University Health Network
Bethlehem, Pennsylvania
Beth Israel Deaconess Med Center
Boston, Massachusetts
Lahey Hospital & Medical Center
Burlington, Massachusetts
Medical University of South Carolina
Charleston, South Carolina
Levin Cancer Institute
Charlotte, North Carolina
Loyola University Chicago
Chicago, Illinois
Cleveland Clinic
Cleveland, Ohio
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas
Texas Oncology-El Paso Cancer Treatment Center Grandview
El Paso, Texas
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72758
Cancer Center Hackensack UMC
Hackensack, New Jersey
Penn State Milton S- Hershey Medical Center
Hershey, Pennsylvania
Texas Oncology - Memorial City
Houston, Texas
Indiana University Health Melvin & Bren Simon Cancer Center
Indianapolis, Indiana
University of California Irvine Medical Center
Irvine, California, 92697
North Shore LIJ Center for Advance Medicine
Lake Success, New York
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada
University of California, Los Angeles (UCLA) - Institute of Urologic Oncology
Los Angeles, California, 90095
University of Wisconsin, Carbone Cancer Center
Madison, Wisconsin
University of Miami
Miami, Florida
Mem Sloan Kettering Cancer Center
New York, New York
NYU Cancer Institute
New York, New York
Nebraska Methodist Hospital
Omaha, Nebraska
Fox Chase Cancer Center
Philadelphia, Pennsylvania
University of Pittsburgh, Hillman Cancer Center
Pittsburgh, Pennsylvania
Stanford Hospital and Clinics
Stanford, California
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida
Northwest Cancer Specialists, P.C.
Tualatin, Oregon
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85718
Texas Oncology - Tyler and Longview
Tyler, Texas
Georgetown University Medical Center
Washington D.C., District of Columbia
Shenandoah Oncology P.C.
Winchester, Virginia
About this study
Official title: A Phase 2 Randomized, Double-Blind Study of Dalantercept and Axitinib Compared to Placebo and Axitinib in Patients With Advanced Renal Cell Carcinoma
The purpose of Part 1 of this study is to evaluate the safety and tolerability of dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (RCC) to determine the recommended dose level of dalantercept in combination with axitinib for Part 2.
The purpose of Part 2 of this study is to determine whether treatment with dalantercept in combination with axitinib prolongs progression free survival (PFS) compared to axitinib alone in patients with advanced renal cell carcinoma (RCC).
Read the detailed description
In Part 1 of the study, groups of subjects received escalating doses of dalantercept; 0.6, 0.9 and 1.2 mg/kg in sequential groups. All subjects received concurrent axitinib 5 mg PO BID. A total of 29 subjects were enrolled i Part 1 of the study.
In Part 2, dalantercept at 0.9 mg/kg once every 3 weeks plus axitinib 5 mg PO BID was compared to placebo plus axitinib 5 mg PO BID. A total of 131 subjects were enrolled in Part 2 for a total of 160 in the study
- Conditions
- Advanced Renal Cell Carcinoma
- Being tested
- Dalantercept and axitinib, Placebo and axitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalantercept and axitinibDrug
Also called ACE-041, Inlyta
Placebo and axitinibDrug
Also called Inlyta
| Study group | Role | What they receive |
|---|---|---|
| Dalantercept 0.9 mg/kg plus axitinib | Experimental | Subcutaneous (SC) injection of dalantercept 0.9 mg/kg once every 3 weeks and oral axitinib 5 mg BID for continuous dosing. Receives: Drug: Dalantercept and axitinib |
| Placebo plus axitinib | Placebo comparator | Subcutaneous injection of normal saline once every 3 weeks and oral axitinib 5 mg BID for continuous dosing Receives: Drug: Placebo and axitinib |
| Dalantercept 0.6 mg/kg | Experimental | Part 1 dose escalation arm 0.6 mg/kg dalantercept once every 3 weeks Receives: Drug: Dalantercept and axitinib |
| Dalantercept 0.9 mg/kg | Experimental | Part 1 dose escalation arm 0.9 mg/kg dalantercept once every 3 weeks Receives: Drug: Dalantercept and axitinib |
| Dalantercept 1.2 mg/kg | Experimental | Part 1 dose escalation arm 1.2 mg/kg dalantercept once every 3 weeks Receives: Drug: Dalantercept and axitinib |
| Dalantercept 1.5 mg/kg | Experimental | Part 1 dose escalation arm 1.5 mg/kg dalantercept once every 3 weeks Receives: Drug: Dalantercept and axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
Outcome measure is intended for Part 1 of the study in order to determine recommended dose level for Part 2.
Measured: Assessed from time of first dose to approximately 30 days after last dose. Participants were allowed to remain on treatment until documented disease progression. The time frame for Part 1 of the study was up to 21.6 months
Part 2: Progression Free Survival (PFS).
PFS was defined as the time from randomization to the date of first documentation of disease progression based on RECIST (version 1.1) or to death due to any cause, whichever occurred first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
RECIST 1.1 defines disease progression as an increase of at least a 20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression)
Measured: Progression free survival is defined as the time from the date of the randomization to the first documented disease progression (according to RECIST v1.1) or death due to any cause. The Time frame for Part 2 was up to 29.0 months
Secondary outcomes (10)
Part 1: Progression Free Survival (PFS).
PFS was defined as the time from randomization to the date of first documentation of disease progression based on RECIST (version 1.1) or to death due to any cause, whichever occurred first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: The time frame for Part 1 of the study was up to 21.6 months
Part 1: Overall Survival (OS). [The Time Frame for Part 1 of the Study Was up to 21.6 Months]
Percentage of Part 1 subjects alive at the end of Part 1 of the study. [The time frame for Part 1 of the study was up to 21.6 months]
Measured: Up to 21.6 months
Part 1: Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number and percentage of patients who have a partial response (PR) or complete response (CR) to therapy. A CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. A PR is defined as a decrease of at least a 30% in the sum of diameters of target lesions, taking as reference the baseline sum diameters. As no subjects in Part 1 experienced a CR, the ORR in Part 1 is defined by the PR
Measured: Up to 21.6 months from randomization in Part 1 of the study
Part 1: Disease Control Rate (DCR)
The number and percentage of patients whose disease shrinks or remains stable. DCR is the sum of the complete, partial and stable disease rates.
Measured: From randomization up to 21.6 months in Part 1 of the study
Part 1: Duration of Response (DoR)
Response duration is measured from the time measurement criteria are first met for objective response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study.
Measured: From randomization up to 21.6 months in Part 1 of the study.
Part 2: Progression Free Survival (PFS) for the Subset of Participants With 2 or More Lines of Prior Systemic Chemotherapy
Progression Free Survival (PFS) for the subset of participants with 2 or more lines of prior systemic chemotherapy. PFS was based upon RECIST 1.1 assessment, as described in outcome measure 2.
Measured: Progression free survival is defined as the time from the date of the randomization to the first documented disease progression (according to RECIST v1.1) or death due to any cause. The Time frame for Part 2 was up to 29.0 months
Part 2: Overall Survival.
The number of months from the date of randomization to the date of death.
Measured: Patients to be contacted every 3 months for up to 12 months (anticipated) for survival follow-up, as well as tumor assessment scans if progression of disease has not previously been documented. The time frame for Part 2 was up to 29.0 months
Part 2: Objective Response Rate.
Objective response rate (ORR) is defined as the number and percentage of patients who have a partial response (PR) or complete response (CR) to therapy. A CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. A PR is defined as a decrease of at least a 30% in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Assessed at 30 days after last dose of study drug; up to 29.0 months for Part 2 of the study
Part 2: Duration of Response
Response duration is measured from the time measurement criteria are first met for objective response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study.
Measured: Assessed at 30 days after the last dose of study drug; up to 29.0 months for Part 2 of the study.
Part 2: Disease Control Rate.
The number and percentage of patients whose disease shrinks or remains stable. DCR is the sum of the complete, partial and stable disease rates.
Measured: Assessed at 30 days after last dose of study drug. The time frame for Part 2 was up to 29.0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2017
- Study completionNov 2017
Why it stopped: The study was terminated by the sponsor following unblinding of the Progression Free Survival endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Renal Cell CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1 of the study involved a dose escalation phase to select a dose for Part 2 of the study. In Part 1, a total of 29 subjects escalated through 3 dose levels of dalantercept: 0.6, 0.9 and 1.2 mg/kg once every 3 weeks. In Part 2, dalantercept (0.9 mg/kg once every 3 weeks) plus axitinib 5 mg PO BID) was compared with placebo plus axitinib 5 mg PO BID. Part 2 enrolled 131 subjects for a total of 160 subjects in the study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727336
- Sponsor's protocol ID
- A041-04
- Other IDs
- ACE-041
- Status last verified
- Sep 2021
- First submitted
- 8 Nov 2012
- Last updated
- 6 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Voss MH, Bhatt RS, Vogelzang NJ, Fishman M, Alter RS, Rini BI, Beck JT, Joshi M, Hauke R, Atkins MB, Burgess E, Logan TF, Shaffer D, Parikh R, Moazzam N, Zhang X, Glasser C, Sherman ML, Plimack ER. A phase 2, randomized trial evaluating the combination of dalantercept plus axitinib in patients with advanced clear cell renal cell carcinoma. Cancer. 2019 Jul 15;125(14):2400-2408. doi: 10.1002/cncr.32061. Epub 2019 Apr 5.
PubMed 30951193
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind Study of Dalantercept and Axitinib Compared to Placebo and Axitinib in Patients With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01727336
- Acronym / sponsor ID
- A041-04
- Conditions
- Advanced Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated by the sponsor following unblinding of the Progression Free Survival endpoint.
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USAIndustry (pharma, biotech, devices)
- Study start
- Dec 2012 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Posted 24 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of Part 1 of this study is to evaluate the safety and tolerability of dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (RCC) to determine the recommended dose level of dalantercept in combination with axitinib for Part 2.
The purpose of Part 2 of this study is to determine whether treatment with dalantercept in combination with axitinib prolongs progression free survival (PFS) compared to axitinib alone in patients with advanced renal cell carcinoma (RCC).
Detailed description
In Part 1 of the study, groups of subjects received escalating doses of dalantercept; 0.6, 0.9 and 1.2 mg/kg in sequential groups. All subjects received concurrent axitinib 5 mg PO BID. A total of 29 subjects were enrolled i Part 1 of the study.
In Part 2, dalantercept at 0.9 mg/kg once every 3 weeks plus axitinib 5 mg PO BID was compared to placebo plus axitinib 5 mg PO BID. A total of 131 subjects were enrolled in Part 2 for a total of 160 in the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Part 1 of the study involved a dose escalation phase to select a dose for Part 2 of the study. In Part 1, a total of 29 subjects escalated through 3 dose levels of dalantercept: 0.6, 0.9 and 1.2 mg/kg once every 3 weeks. In Part 2, dalantercept (0.9 mg/kg once every 3 weeks) plus axitinib 5 mg PO BID) was compared with placebo plus axitinib 5 mg PO BID. Part 2 enrolled 131 subjects for a total of 160 subjects in the study
| Arm | Type | Receives |
|---|---|---|
| Dalantercept 0.9 mg/kg plus axitinib | Experimental | Drug: Dalantercept and axitinibSubcutaneous (SC) injection of dalantercept 0.9 mg/kg once every 3 weeks and oral axitinib 5 mg BID for continuous dosing. |
| Placebo plus axitinib | Placebo comparator | Drug: Placebo and axitinibSubcutaneous injection of normal saline once every 3 weeks and oral axitinib 5 mg BID for continuous dosing |
| Dalantercept 0.6 mg/kg | Experimental | Drug: Dalantercept and axitinibPart 1 dose escalation arm 0.6 mg/kg dalantercept once every 3 weeks |
| Dalantercept 0.9 mg/kg | Experimental | Drug: Dalantercept and axitinibPart 1 dose escalation arm 0.9 mg/kg dalantercept once every 3 weeks |
| Dalantercept 1.2 mg/kg | Experimental | Drug: Dalantercept and axitinibPart 1 dose escalation arm 1.2 mg/kg dalantercept once every 3 weeks |
| Dalantercept 1.5 mg/kg | Experimental | Drug: Dalantercept and axitinibPart 1 dose escalation arm 1.5 mg/kg dalantercept once every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed, advanced, predominantly clear cell renal cell carcinoma (RCC).
- Part 1: Progression of disease following up to three lines of prior therapy, including at least one approved VEGF receptor tyrosine kinase inhibitor for RCC. Adjuvant therapy is permitted as one line of prior therapy.
- Part 2: Progression of disease following one VEGF pathway inhibitor for RCC (e.g. sunitinib, pazopanib, sorafenib, bevacizumab, tivozanib, or cabozantinib) inclusive of adjuvant therapy if there was documented disease progression during treatment. Patients may have received one additional line of an approved mTOR kinase inhibitor (e.g. everolimus, temsirolimus). Prior exposure to investigational and/or approved anticancer immune therapies is permitted.
- A minimum of 1 week since the last dose of prior therapy (a minimum of 4 weeks since anticancer immune therapy or bevacizumab +/- interferon).
- Measurable disease that is evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Key exclusion criteria (24 listed)
- Clinically significant organ/system disease unrelated to RCC that in the judgment of the investigator should preclude treatment with dalantercept or axitinib.
- Clinically significant cardiovascular risk.
- Known CNS metastases or leptomeningeal disease:
- For Part 1, patients with CNS metastases treated with whole brain radiotherapy, gamma knife, and/or surgery who are considered stable by CNS imaging and are not being treated with corticosteroids 6 weeks prior to study day 1 may be enrolled.
- For Part 2, patients with CNS metastases treated stereotactic radio-surgery (SRS), and/or surgery who are considered stable by CNS imaging for at least 2 months prior to enrollment and are not being treated with corticosteroids 6 weeks prior to study day 1 may be enrolled.
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 |
|---|---|---|
| Dalantercept and axitinibAlso: ACE-041, Inlyta | Drug | Dalantercept 0.6 mg/kg, Dalantercept 0.9 mg/kg, Dalantercept 0.9 mg/kg plus axitinib, Dalantercept 1.2 mg/kg, Dalantercept 1.5 mg/kg |
| Placebo and axitinibAlso: Inlyta | Drug | Placebo plus axitinib |
Primary outcome
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
Time frame: Assessed from time of first dose to approximately 30 days after last dose. Participants were allowed to remain on treatment until documented disease progression. The time frame for Part 1 of the study was up to 21.6 months
Outcome measure is intended for Part 1 of the study in order to determine recommended dose level for Part 2.
Part 2: Progression Free Survival (PFS).
Time frame: Progression free survival is defined as the time from the date of the randomization to the first documented disease progression (according to RECIST v1.1) or death due to any cause. The Time frame for Part 2 was up to 29.0 months
PFS was defined as the time from randomization to the date of first documentation of disease progression based on RECIST (version 1.1) or to death due to any cause, whichever occurred first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. RECIST 1.1 defines disease progression as an increase of at least a 20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression)
10 secondary outcomes
Part 1: Progression Free Survival (PFS).
Time frame: The time frame for Part 1 of the study was up to 21.6 months
Part 1: Overall Survival (OS). [The Time Frame for Part 1 of the Study Was up to 21.6 Months]
Time frame: Up to 21.6 months
Part 1: Objective Response Rate (ORR)
Time frame: Up to 21.6 months from randomization in Part 1 of the study
Part 1: Disease Control Rate (DCR)
Time frame: From randomization up to 21.6 months in Part 1 of the study
Part 1: Duration of Response (DoR)
Time frame: From randomization up to 21.6 months in Part 1 of the study.
Part 2: Progression Free Survival (PFS) for the Subset of Participants With 2 or More Lines of Prior Systemic Chemotherapy
Time frame: Progression free survival is defined as the time from the date of the randomization to the first documented disease progression (according to RECIST v1.1) or death due to any cause. The Time frame for Part 2 was up to 29.0 months
Part 2: Overall Survival.
Time frame: Patients to be contacted every 3 months for up to 12 months (anticipated) for survival follow-up, as well as tumor assessment scans if progression of disease has not previously been documented. The time frame for Part 2 was up to 29.0 months
Part 2: Objective Response Rate.
Time frame: Assessed at 30 days after last dose of study drug; up to 29.0 months for Part 2 of the study
Part 2: Duration of Response
Time frame: Assessed at 30 days after the last dose of study drug; up to 29.0 months for Part 2 of the study.
Part 2: Disease Control Rate.
Time frame: Assessed at 30 days after last dose of study drug. The time frame for Part 2 was up to 29.0 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30951193Voss MH, Bhatt RS, Vogelzang NJ, Fishman M, Alter RS, Rini BI, Beck JT, Joshi M, Hauke R, Atkins MB, Burgess E, Logan TF, Shaffer D, Parikh R, Moazzam N, Zhang X, Glasser C, Sherman ML, Plimack ER. A phase 2, randomized trial evaluating the combination of dalantercept plus axitinib in patients with advanced clear cell renal cell carcinoma. Cancer. 2019 Jul 15;125(14):2400-2408. doi: 10.1002/cncr.32061. Epub 2019 Apr 5.
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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.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dalantercept and axitinib in people with Advanced Renal Cell Carcinoma, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA at 36 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 24 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: stopped early, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability. (time frame: Assessed from time of first dose to approximately 30 days after last dose. Participants were allowed to remain on treatment until documented disease progression. The time frame for Part 1 of the study was up to 21.6 months). 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 NCT01727336, 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 Oct 2022.