Trial · NCT01012817
Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
NCT01012817, Phase 1, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2023-07-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer. Trials, record NCT01012817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01012817
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
- NCT number
- NCT01012817
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 88 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Malignant Solid Neoplasm, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Unresectable Solid Neoplasm
- Interventions
- Laboratory Biomarker Analysis, Pharmacogenomic Study, Pharmacological Study, Topotecan Hydrochloride, Veliparib
- First posted
- 2009-11-13
- Last updated
- 2026-09-14
- Results first posted
- 2023-07-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) | 4 weeks | The number of patients with a dose limiting toxicity will be reported. Dose-limiting toxicity (DLT) will be defined as a cycle 1 adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria: Grade 4 anemia, grade 4 neutrophil count decrease, grade 4 platelet count decrease, Serum creatinine \>= 2 times baseline or ≥ 2 times the upper limit of normal if baseline is \< the upper limit of normal, or other \>= Grade 3 as per NCI Common Terminology Criteria for Adverse Events CTCAE version 4.0. \>= Grade 3 nausea, vomiting, or diarrhea with maximal supportive treatment(s) will be considered dose-limiting. Grade 3 fatigue or anorexia will not be considered dos |
| Primary | Percent of Patients With Tumor Response, Defined as Complete Response or Partial Response as Assessed Using Response Evaluation Criteria In Solid Tumors | Up to 48 weeks (12 courses) | The proportion of successes will be estimated by the number of successes(CR or PR) divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner (1987). Complete Response (CR) is defined as disappearance of all target lesions and, if non target lesions exist, the disappearance of all non-target lesions and normalization of tumor maker level. At least 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum. |
| Secondary | Overall Survival | The time from registration to death due to any cause, assessed up to 5 years | The distribution of survival time for phase 2 patients will be estimated using the method of Kaplan-Meier. |
| Secondary | Progression Free Survival | The time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years | The distribution of progression free survival will be estimated using the method of Kaplan-Meier. |
| Secondary | Duration of Response | Up to 5 years | Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a complete response or partial response to the earliest date progression is documented. |
| Secondary | Time to Treatment Failure | The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, assessed up to 5 years | Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. |
| Secondary | Adverse Events, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 5 years | The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) | 4 weeks | All phase 1 patients that received treatment per protocol and evaluated for adverse events. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percent of Patients With Tumor Response, Defined as Complete Response or Partial Response as Assessed Using Response Evaluation Criteria In Solid Tumors | Up to 48 weeks (12 courses) | All treated patients that were evaluated for disease response | percent of patients with response | NUMBER |
| SECONDARY | Overall Survival | The time from registration to death due to any cause, assessed up to 5 years | |||
| SECONDARY | Progression Free Survival | The time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years | |||
| SECONDARY | Duration of Response | Up to 5 years | |||
| SECONDARY | Time to Treatment Failure | The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, assessed up to 5 years | |||
| SECONDARY | Adverse Events, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 5 years |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) | Phase 1 Dose Level 1 | 0 | Participants | ||
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) | Phase 1 Dose Level 2 | 0 | Participants | ||
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) | Phase 1 Dose Level 3 | 0 | Participants | ||
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) | Phase 1 Dose Level 4 | 0 | Participants | ||
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) | Phase 1 Dose Level 5 | 3 | Participants | ||
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) | Phase 1 Dose Level 6 | 2 | Participants | ||
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) | Phase 1 Dose Level 7 | 0 | Participants | ||
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) | Phase 1 Dose Level 8 | 0 | Participants | ||
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) | Phase 1 Dose Level 9 | 0 | Participants | ||
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) | Phase 1 Dose Level 10 | 1 | Participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1 Dose Level 1 | 3 | |
| Overall Study | STARTED | Phase 1 Dose Level 2 | 3 | |
| Overall Study | STARTED | Phase 1 Dose Level 3 | 3 | |
| Overall Study | STARTED | Phase 1 Dose Level 4 | 4 | |
| Overall Study | STARTED | Phase 1 Dose Level 5 | 6 | |
| Overall Study | STARTED | Phase 1 Dose Level 6 | 7 | |
| Overall Study | STARTED | Phase 1 Dose Level 7 | 3 | |
| Overall Study | STARTED | Phase 1 Dose Level 8 | 4 | |
| Overall Study | STARTED | Phase 1 Dose Level 9 | 3 | |
| Overall Study | STARTED | Phase 1 Dose Level 10 | 6 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events3,192
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Dose Level 1 | 3 | 3 | 40 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Dose Level 10 | 6 | 6 | 36 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Dose Level 11 | 5 | 5 | 22 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Dose Level 12 | 6 | 7 | 53 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Dose Level 13 | 3 | 3 | 21 |
| other | Anemia | Blood and lymphatic system disorders | Phase 2 | 21 | 31 | 45 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Dose Level 2 | 2 | 3 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Dose Level 3 | 3 | 3 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Dose Level 4 | 4 | 4 | 11 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Dose Level 5 | 6 | 6 | 112 |
1 to 10 of 3,192Source ClinicalTrials.gov
See all 3,192 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 Dose Level 1 | 0 | 3 |
| Total, all-cause mortality | Phase 1 Dose Level 10 | 2 | 6 |
| Total, all-cause mortality | Phase 1 Dose Level 11 | 0 | 5 |
| Total, all-cause mortality | Phase 1 Dose Level 12 | 1 | 7 |
| Total, all-cause mortality | Phase 1 Dose Level 13 | 1 | 3 |
| Total, all-cause mortality | Phase 2 | 2 | 31 |
| Total, all-cause mortality | Phase 1 Dose Level 2 | 0 | 3 |
| Total, all-cause mortality | Phase 1 Dose Level 3 | 1 | 3 |
| Total, all-cause mortality | Phase 1 Dose Level 4 | 1 | 4 |
| Total, all-cause mortality | Phase 1 Dose Level 5 | 1 | 6 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants5
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P50CA136393 | Mayo Clinic Ovarian Cancer SPORE | KAUFMANN, SCOTT H; Bakkum-Gamez, Jamie N | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 2009 to 2026 | NIH RePORTER |
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| UM1CA186686 | NCI Experimental Therapeutics-Clinical Trials Network with Phase 1 Emphasis | ADJEI, ALEX A. | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 2014 to 2019 | NIH RePORTER |
| P50CA083639 | The University of Texas M. D. Anderson Cancer Center SPORE in Ovarian Cancer | BAST, ROBERT C | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1999 to 2015 | NIH RePORTER |
| U01CA069912 | Phase I Clinical Trials of Anticancer Agents | ERLICHMAN, CHARLES | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1995 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01012817
GET https://conductscience.org/api/trials/v1/NCT01012817/results?page=2