Who is sponsoring NCT01010126?

NCT01010126 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT01010126?

Interventions in NCT01010126: Bevacizumab, Temsirolimus.

What condition does NCT01010126 study?

NCT01010126 studies Adult Hepatocellular Carcinoma, Advanced Adult Hepatocellular Carcinoma, Endometrial Serous Adenocarcinoma, Localized Non-Resectable Adult Liver Carcinoma, Lung Carcinoid Tumor, Malignant Pancreatic Gastrinoma, Malignant Pancreatic Glucagonoma, Malignant Pancreatic Insulinoma, Malignant Pancreatic Somatostatinoma, Metastatic Digestive System Neuroendocrine Tumor G1, Ovarian Carcinosarcoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Surface Papillary Adenocarcinoma, Pancreatic Alpha Cell Adenoma, Pancreatic Beta Cell Adenoma, Pancreatic Delta Cell Adenoma, Pancreatic G-Cell Adenoma, Pancreatic Polypeptide Tumor, Recurrent Adult Liver Carcinoma, Recurrent Digestive System Neuroendocrine Tumor G1, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Pancreatic Neuroendocrine Carcinoma, Recurrent Primary Peritoneal Carcinoma, Recurrent Uterine Corpus Carcinoma, Regional Digestive System Neuroendocrine Tumor G1, Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIA Uterine Corpus Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer, Stage IIIB Uterine Corpus Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IIIC Uterine Corpus Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer, Stage IVA Uterine Corpus Cancer, Stage IVB Uterine Corpus Cancer, Uterine Carcinosarcoma.

Is NCT01010126 still recruiting?

NCT01010126 is currently completed. Last updated 25 January 2019.

Are results published for NCT01010126?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-01-25 · How we verify

NCT01010126

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer

Completed Phase 2 Results posted Last updated 25 January 2019

What this trial tests

Phase 2 trial testing Bevacizumab in Adult Hepatocellular Carcinoma in 252 participants. Completed in 13 March 2017.

Timeline

8 September 2009

Primary endpoint
13 March 2017

13 March 2017

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	252
Start date	8 September 2009
Primary completion	13 March 2017
Estimated completion	13 March 2017
Sites	61 locations across Canada, United States

Drugs / interventions tested

Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
Temsirolimus (temsirolimus) — full drug profile →

Conditions studied

Adult Hepatocellular Carcinoma — all drugs for Adult Hepatocellular Carcinoma →
Advanced Adult Hepatocellular Carcinoma — all drugs for Advanced Adult Hepatocellular Carcinoma →
Endometrial Serous Adenocarcinoma — all drugs for Endometrial Serous Adenocarcinoma →
Localized Non-Resectable Adult Liver Carcinoma — all drugs for Localized Non-Resectable Adult Liver Carcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Adult Hepatocellular Carcinoma or Advanced Adult Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression Free Survival Rate Primary · 6 months

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The 6-month progression free survival rate is the proportion of evaluable patients progression-free 6 months from registration. The 6-month progression-free rate is defined as the total number of efficacy evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of evaluable p

Group	Value	95% CI
Endometrial Cohort	0.52	0.35 – 0.77
Ovarian Cohort	0.40	0.29 – 0.55
Hepatocellular Cohort	0.71	0.54 – 0.94
Carcinoid Cohort	0.84	0.75 – 0.95
Islet Cell (Double Agent) Cohort	0.85	0.75 – 0.95
Islet Cell (Bevacizumab-only) Cohort	0.87	0.74 – 1.00

Tumor Response Rate Primary · Up to 3 years

Tumor response rate defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of efficacy evaluable patients enrolled on study. Patients were evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. In brief, a Complete Response (CR) means the complete disappearance of all target lesions and a reduction in each lymph node to \<1 cm. A Partial Response (PR) is defined as a 30% decrease in the sum of the longest diameter of the non-nodal target lesion from baseline. Ea

Group	Value	95% CI
Endometrial Cohort	0.31	0.14 – 0.52
Ovarian Cohort	0.31	0.20 – 0.45
Hepatocellular Cohort	0.19	0.06 – 0.38
Carcinoid Cohort	0.12	0.05 – 0.24
Islet Cell (Double Agent) Cohort	0.40	0.27 – 0.53
Islet Cell (Bevacizumab-only) Cohort	0.17	0.05 – 0.37

Duration of Response Secondary · Time from date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 3 years

Duration of response is defined for all evaluable patients who have achieved a response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Objective response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) as described in Primary Objective 2 in this report. Median duration of response and the confidence interval for the median duration will be computed.

Group	Value	95% CI
Endometrial Cohort	25.1	0 – 35.5
Ovarian Cohort	6.4	3.7 – 10.8
Hepatocellular Cohort	6.4	0 – 11.1
Carcinoid Cohort	15.0	0 – 18.8
Islet Cell (Double Agent) Cohort	11.3	8.8 – 21.2
Islet Cell (Bevacizumab-only) Cohort	10.9	3.7 – 34.1

Incidence of Adverse Events Secondary · Every cycle of treatment, up to 3 years

Adverse events are defined as events that are classified as either possibly, probably, or definitely related to study treatment, graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0. The number of patients reporting grade 3 or higher adverse events at least possibly related to treatment are reported here. For a complete list of all reported adverse events, please see the adverse events section of this report.

Grade 3 Adverse Event

Group	Value	95% CI
Endometrial Cohort	17
Ovarian Cohort	32
Hepatocellular Cohort	24
Carcinoid Cohort	32
Islet Cell (Double Agent) Cohort	36
Islet Cell (Bevacizumab-only) Cohort	13

Grade 4 Adverse Event

Group	Value	95% CI
Endometrial Cohort	1
Ovarian Cohort	6
Hepatocellular Cohort	0
Carcinoid Cohort	6
Islet Cell (Double Agent) Cohort	8
Islet Cell (Bevacizumab-only) Cohort	0

Grade 5 Adverse Event

Group	Value	95% CI
Endometrial Cohort	1
Ovarian Cohort	0
Hepatocellular Cohort	1
Carcinoid Cohort	2
Islet Cell (Double Agent) Cohort	0
Islet Cell (Bevacizumab-only) Cohort	0

Overall Survival Secondary · Time from registration to death, assessed up to 3 years

Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method.

Group	Value	95% CI
Endometrial Cohort	11.5	6.5 – NA
Ovarian Cohort	16.3	11.1 – 21.9
Hepatocellular Cohort	14.8	9.7 – 18.1
Carcinoid Cohort	32.7	25.2 – 38.3
Islet Cell (Double Agent) Cohort	35.0	14.6 – NA
Islet Cell (Bevacizumab-only) Cohort	NA	30.6 – NA

Time to Disease Progression Secondary · Time from registration to disease progression, assessed up to 3 years

Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for evaluation, that patient will be censored for progression of disease at day one post-registration.

Group	Value	95% CI
Endometrial Cohort	6.0	2.5 – 9.8
Ovarian Cohort	5.6	4.3 – 6.4
Hepatocellular Cohort	8.0	5.8 – 10.9
Carcinoid Cohort	15.2	11.4 – 24.2
Islet Cell (Double Agent) Cohort	13.1	11.2 – 16.6
Islet Cell (Bevacizumab-only) Cohort	18.0	10.6 – 37.0

Time to Treatment Failure Secondary · Time from study entry to the date patients end treatment, assessed up to 3 years

Time to treatment failure is defined as the time from study entry to the date patients end treatment.Time to treatment failure will be evaluated using the method of Kaplan-Meier.

Group	Value	95% CI
Endometrial Cohort	3.8	2.3 – 6.4
Ovarian Cohort	4.5	2.7 – 5.6
Hepatocellular Cohort	6.5	2.3 – 8.0
Carcinoid Cohort	5.5	4.4 – 8.1
Islet Cell (Double Agent) Cohort	11.3	8.6 – 13.3
Islet Cell (Bevacizumab-only) Cohort	11.8	5.8 – 18.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Endometrial Cohort

Serious: 16/26 (62%)

Deaths: 2/26

Ovarian Cohort

Serious: 34/58 (59%)

Deaths: 1/58

Hepatocellular Cohort

Serious: 13/27 (48%)

Deaths: 3/27

Carcinoid Cohort

Serious: 36/57 (63%)

Deaths: 3/57

Islet Cell (Double Agent) Cohort

Serious: 27/55 (49%)

Deaths: 0/55

Islet Cell (Bevacizumab-only) Cohort

Serious: 6/24 (25%)

Deaths: 0/24

Serious adverse events (141 terms)

Reaction	System	Endometrial Cohort	Ovarian Cohort	Hepatocellular Cohort	Carcinoid Cohort	Islet Cell (Double Agent) …	Islet Cell (Bevacizumab-on…
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—
Hemoglobin decreased	Blood and lymphatic system disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—
Colonic perforation	Gastrointestinal disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Gastrointestinal disorder	Gastrointestinal disorders	—	—	—	—	—	—
Fever	General disorders	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—
Blood glucose increased	Metabolism and nutrition disorders	—	—	—	—	—	—
Serum potassium decreased	Metabolism and nutrition disorders	—	—	—	—	—	—
Serum sodium decreased	Metabolism and nutrition disorders	—	—	—	—	—	—
Muscle weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Confusion	Psychiatric disorders	—	—	—	—	—	—
Vaginal fistula	Reproductive system and breast disorders	—	—	—	—	—	—
Cardiac disorder	Cardiac disorders	—	—	—	—	—	—
Myocardial ischemia	Cardiac disorders	—	—	—	—	—	—
Ear, nose and throat examination abnormal	Gastrointestinal disorders	—	—	—	—	—	—
Hemorrhoids	Gastrointestinal disorders	—	—	—	—	—	—
Lower gastrointestinal hemorrhage	Gastrointestinal disorders	—	—	—	—	—	—

Other adverse events (238 terms — click to expand)

Reaction	System	Endometrial Cohort	Ovarian Cohort	Hepatocellular Cohort	Carcinoid Cohort	Islet Cell (Double Agent) …	Islet Cell (Bevacizumab-on…
Platelet count decreased	Investigations	—	—	—	—	—	—
Hemoglobin decreased	Blood and lymphatic system disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Serum cholesterol increased	Investigations	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—
Leukocyte count decreased	Investigations	—	—	—	—	—	—
Protein urine positive	Renal and urinary disorders	—	—	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—	—	—
Ear, nose and throat examination abnormal	Gastrointestinal disorders	—	—	—	—	—	—
Serum triglycerides increased	Metabolism and nutrition disorders	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Blood glucose increased	Metabolism and nutrition disorders	—	—	—	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—
Mucositis oral	Gastrointestinal disorders	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Serum potassium decreased	Metabolism and nutrition disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Rash desquamating	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Hemorrhage nasal	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Rash acneiform	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Alkaline phosphatase increased	Investigations	—	—	—	—	—	—
Weight loss	Investigations	—	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—	—
Creatinine increased	Investigations	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Edema limbs	General disorders	—	—	—	—	—	—
Bilirubin increased	Investigations	—	—	—	—	—	—
Serum sodium decreased	Metabolism and nutrition disorders	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—
Serum albumin decreased	Metabolism and nutrition disorders	—	—	—	—	—	—
Taste alteration	Nervous system disorders	—	—	—	—	—	—
Skin disorder	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—
Serum calcium decreased	Metabolism and nutrition disorders	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Hemorrhoids	Gastrointestinal disorders	—	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Dehydration, Hemoglobin decreased, Nausea, Small intestinal obstruction, Vomiting, Fatigue, Hypertension.

Data from ClinicalTrials.gov NCT01010126 adverse events section.

Sponsor's own description

This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Role of lysosomes in physiological activities, diseases, and therapy.
Zhang Z, Yue P, Lu T, Wang Y, et al · · 2021 · cited 238× · PMID 33990205 · DOI 10.1186/s13045-021-01087-1
Targeting the PI3K/Akt/mTOR Pathway in Hepatocellular Carcinoma.
Sun EJ, Wankell M, Palamuthusingam P, McFarlane C, et al · · 2021 · cited 199× · PMID 34829868 · DOI 10.3390/biomedicines9111639
Therapeutic targeting of autophagy in disease: biology and pharmacology.
Cheng Y, Ren X, Hait WN, Yang JM. · · 2013 · cited 188× · PMID 23943849 · DOI 10.1124/pr.112.007120
Tumor Microenvironment in Ovarian Cancer: Function and Therapeutic Strategy.
Yang Y, Yang Y, Yang J, Zhao X, et al · · 2020 · cited 168× · PMID 32850861 · DOI 10.3389/fcell.2020.00758
Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
Role of the Mammalian Target of Rapamycin Pathway in Liver Cancer: From Molecular Genetics to Targeted Therapies.
Lu X, Paliogiannis P, Calvisi DF, Chen X. · · 2021 · cited 104× · PMID 32394479 · DOI 10.1002/hep.31310
PI3K/AKT/mTOR Pathway in Ovarian Cancer Treatment: Are We on the Right Track?
Gasparri ML, Bardhi E, Ruscito I, Papadia A, et al · · 2017 · cited 92× · PMID 29093603 · DOI 10.1055/s-0043-118907
Multicenter Phase II Trial of Temsirolimus and Bevacizumab in Pancreatic Neuroendocrine Tumors.
Hobday TJ, Qin R, Reidy-Lagunes D, Moore MJ, et al · · 2015 · cited 88× · PMID 25488966 · DOI 10.1200/jco.2014.56.2082

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01010126 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 25 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01010126.

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